Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Federal RegisterAug 17, 2022
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 800, 801, 808, and 874
[Docket No. FDA-2021-N-0555]
RIN 0910-AI21
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
AGENCY:
Food and Drug Administration, Department of Health and Human Services (HHS).
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.
DATES:
Effective date:
This rule is effective October 17, 2022.
Compliance dates:
For hearing aids that have been legally offered for sale prior to October 17, 2022, including hearing aids that already have a 510(k) clearance, compliance with the new or revised requirements must be achieved by April 14, 2023. For hearing aids that have not been offered for sale prior to October 17, 2022, or have been offered for sale but are required to submit a new 510(k) due to changes unrelated to this rule, compliance with the new or revised requirements applicable to the hearing aid, and obtaining 510(k) clearance if applicable, must be achieved before marketing the device on or after October 17, 2022.
Incorporation by reference:
The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register as of October 17, 2022.
ADDRESSES:
For access to the docket to read background documents or comments received, go to
https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this final rule, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
With regard to the final rule:
Srinivas Nandkumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6480,
Srinivas.Nandkumar@fda.hhs.gov.
With regard to the information collection:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
Purpose of the Final Rule
Summary of the Major Provisions of the Final Rule
Legal Authority
Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in this Document
III. Background
A. Need for the Regulation
B. History of this Rulemaking and Public Participation
C. Summary of Changes Between Proposed and Final Rules
D. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA's Responses
A. Device Classification and Marketing
B. Scope (§ 800.30(a))
C. Definitions (§§ 800.30(b) and 801.422(b))
D. Labeling (§ 800.30(c))
E. Output Limits (§ 800.30(d))
F. Other Device Requirements (§ 800.30(e) and (f))
G. Conditions for OTC Sale (§ 800.30(g))
H. Preemption Provisions (§ 800.30(h))
I. Repeal of Restrictions and Modifications for Prescription Labeling (§§ 801.420, 801.421, 801.422)
J. Other Amendments
VI. Effective and Compliance Dates
A. Effective Date
B. Compliance Dates for Hearing Aids Not Legally Offered for Sale Prior to the Effective Date
C. Compliance Dates for Hearing Aids Legally Offered for Sale Prior to the Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environment Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention. Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price). FDA is finalizing rules to address some of these concerns.
Moreover, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) directs FDA to establish a category of OTC hearing aids through rulemaking, and FDARA sets forth various requirements for OTC hearing aids, including for reasonable assurance of safety and effectiveness, as well as Federal preemption provisions. In addition to protecting and promoting the public health, these rules establish the OTC category and implement the requirements of FDARA.
B. Summary of the Major Provisions of the Final Rule
FDA is establishing a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids are intended to address perceived mild to moderate hearing loss in people aged 18 or older. Along with the OTC category, we are finalizing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the new OTC category. We have determined that the requirements set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology.
Among other things, FDARA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls. We are finalizing general controls for OTC hearing aids consistent with FDARA.
We are finalizing lower output limits than we proposed but have not substantially changed the other electroacoustic performance requirements for OTC hearing aids. We have simplified the phrasing throughout the required labeling and have restated the maximum insertion depth for OTC hearing aids in terms of a fixed measurement. However, we are not realigning the air-conduction hearing aid classification regulations as proposed.
This rulemaking also affects other regulations that applied to hearing aids. FDA had established device restrictions for hearing aids that included labeling requirements as well as conditions for sale. We are removing these device restrictions for hearing aids and establishing a new regulation for prescription hearing aid labeling. Further, FDA had by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are removing the regulations codifying these decisions and establishing other regulations clarifying some of the effects of statutory preemption under FDARA.
C. Legal Authority
The FD&C Act establishes a comprehensive system for the regulation of devices intended for human use. Hearing aids are devices intended for human use and so are subject to, among other requirements, the device provisions of the FD&C Act. FDA has authority to establish regulatory controls needed to provide reasonable assurance of safety and effectiveness for these devices. As such, FDA is establishing regulatory controls for OTC hearing aids and amending regulatory controls for prescription hearing aids. Moreover, the FD&C Act directs the establishment of an electronic radiation control program, and hearing aids and personal sound amplification products (PSAPs) are electronic products, subject to the electronic radiation control requirements.
Specific to OTC hearing aids, the FD&C Act and FDARA authorize multiple controls, including authority for FDA to establish requirements for device labeling, output limits, conditions for sale and distribution, and other requirements that provide reasonable assurance of safety and effectiveness of OTC hearing aids. FDARA specifically directs FDA to establish a category of OTC hearing aids by regulation that must include the aforementioned requirements.
More generally, the FD&C Act further provides for labeling requirements as general controls such that devices (and other medical products) will not be misbranded. The FD&C Act also authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. We are establishing the following regulations pursuant to these authorities and to fulfill the directive under FDARA.
Additionally, both the FD&C Act and FDARA include preemption provisions applicable to hearing aids.
D. Costs and Benefits
This rule to establish OTC hearing aids and align other regulations generates potential cost savings for consumers with perceived mild to moderate hearing impairment who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online. This rule also generates costs for hearing aid manufacturers for changing labeling of existing hearing aids as well as for reading the rule and revising internal standard operating procedures in response to the rule. We estimate benefits of between $6 million and $147 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $63 million per year. We estimate annualized costs of between $1 million and $2 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $1 million per year. Combining benefits and costs, we used Monte Carlo analysis to estimate annualized net benefits of between $5 million and $145 million per year based on the 5th and 95th Monte Carlo percentile results with a mean of $62 million per year at both 3 percent and 7 percent discount rates.
II. Table of Abbreviations and Acronyms Commonly Used in This Document
Abbreviation/acronym
What it means
510(k)
A premarket notification for certain devices.
ANSI
American National Standards Institute.
APA
Administrative Procedure Act.
ASA
Acoustical Society of America.
ASHA
American Speech-Language-Hearing Association.
CDRH
Center for Devices and Radiological Health.
CFR
Code of Federal Regulations.
cm
3
Centimeter cubed (cubic centimeter).
CTA
Consumer Technology Association.
dB
Decibel.
dBA
A-weighted decibel.
EA
Environmental assessment.
ENT
Ear-Nose-Throat.
FDA
Food and Drug Administration.
FD&C Act
Federal Food, Drug, and Cosmetic Act.
FDARA
FDA Reauthorization Act of 2017.
FONSI
Finding of no significant impact.
FR
Federal Register.
FRIA
Final Regulatory Impact Analysis.
IQA
Information Quality Act.
ISO
International Organization for Standardization.
ITU
International Telecommunication Union.
mm
Millimeter.
ms
Millisecond.
MSW
Municipal solid waste.
NASEM
National Academies of Sciences, Engineering, and Medicine.
NIOSH
National Institute for Occupational Safety and Health.
OMB
Office of Management and Budget.
OSPL90
Output sound pressure level with 90-dB input.
OTC
Over-the-counter.
PRA
Paperwork Reduction Act of 1995.
PSAP
Personal sound amplification product.
Pub. L
Public Law.
RMS
Root mean square.
SPL
Sound pressure level.
U.S.C
United States Code.
WHO
World Health Organization.
III. Background
FDA is defining and establishing general controls for an OTC category of hearing aids. We intend these controls to provide for reasonable assurance of safety and effectiveness for these devices, thereby protecting the public health. We also intend these controls to help improve access to and foster innovation in hearing aid technology for Americans, thereby promoting the public health. We are making various other revisions, as described in this document, to align existing regulations with statutory requirements and the new OTC category.
For brevity, we will use the following terms as shorthand in this document: “Over-the-Counter Hearing Aid Controls” for the general controls for OTC hearing aids that we are finalizing under § 800.30 (21 CFR 800.30).
“Commercial activity involving OTC hearing aids” to refer to any or all of the following activities: servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online.
“Customizable” or “customization,” unless otherwise noted, to refer to the elements of the statutory definition for OTC hearing aids described in section 520(q)(1)(A)(iii) and (iv) of the FD&C Act (21 U.S.C. 360j(q)(1)(A)(iii) and (iv)). That is, for the purposes of this document, a customizable hearing aid is one that, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user's hearing needs. To do so, the hearing aid may use wireless technology or include tests for self-assessment of hearing loss. (See also the response to Comment 1 explaining customization in more technical terms.)
“Involvement of a licensed person” to refer to the supervision, prescription, or other order, involvement, or intervention of a licensed person.
“State or local requirement” to refer to any State or local law, regulation, order, or other requirement.
A. Need for the Regulation
Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life (Refs. 1 and 2). Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention (Ref. 3). The use of hearing aids has been linked to, among other health benefits, reductions in the incidence or severity of cognitive decline, depression, and other health problems in older adults (Refs. 2, 4, and 5). Additionally, benefits of hearing aid use can include improved social participation and a better quality of life.
Besides health benefits for individuals, more-widespread adoption of hearing aids could have broader effects. By increasing social participation, hearing aids could help to improve inclusion of individuals in family, economic, civic, and religious life. Thus, reducing barriers to hearing aid access might contribute to such improvements. This could be particularly true for people of color, rural Americans, low-income individuals, and others for whom barriers to hearing aid access may be especially burdensome.
Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price) (Ref. 6). FDA is finalizing rules to address some of these concerns.
Moreover, section 709 of FDARA directs FDA to establish a category of OTC hearing aids through rulemaking, and sets forth various requirements for OTC hearing aids, including for reasonable assurance of safety and effectiveness, as well as Federal preemption provisions. In addition to protecting and promoting the public health, these rules establish the OTC category and implement the requirements of FDARA.
B. History of This Rulemaking and Public Participation
On October 20, 2021, in the
Federal Register
, FDA proposed multiple regulatory changes, including proposing requirements for OTC hearing aids, that would serve to provide reasonable assurance of safety and effectiveness of hearing aids, address barriers to access to hearing aids, and effectuate the requirements of section 709 of FDARA (86 FR 58150). Although the October 2021 proposal was the first step in this rulemaking, the proposal followed other steps FDA had already taken to initiate an update of the regulatory framework for hearing aids. Please refer to the aforementioned issue of the
Federal Register
for further details on the proposal and other steps taken by FDA.
We received more than 1,000 comments on the proposed rule by the close of the comment period, which was January 18, 2022. Commenters included consumers, professionals, professional associations, hearing aid manufacturers, public health organizations, public advocacy groups, members of Congress, and State agencies. We describe and respond to the comments in section V of this document. We have grouped similar comments together under the same number, and in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which we received comments.
C. Summary of Changes Between Proposed and Final Rules
In response to comments, we have made (and declined) a number of changes for the final rule. The following summarizes the outcomes that may be of greatest interest to readers:
Output limits.
We are finalizing lower output limits than we proposed. The general limit will be 111 decibels of sound pressure level (dB SPL), with 117 dB SPL allowable for devices while input-controlled compression is activated.
Gain limit.
We did not propose, and are not finalizing, a separate gain limit.
Design requirements.
We have revised the allowable insertion depth. The most medial (innermost) component of an OTC hearing aid must be reasonably expected to remain at least 10 millimeters (mm) from the tympanic membrane (eardrum). We are also requiring that all OTC hearing aids have a user-adjustable volume control.
Labeling.
We have improved phrasing throughout the labeling to make it more understandable for hearing aid users (non-experts).
Conditions for sale.
We are not requiring age verification for the sale of OTC hearing aids. Prescription hearing aid sales will be subject to the requirements in § 801.109 (21 CFR 801.109), including that they be sold only to or on the prescription or other order of a practitioner licensed by law to use or order the use of (prescribe) the devices (which is as proposed).
Scope and definitions.
Perceived mild to moderate hearing impairment remains the scope of the intended use of OTC hearing aids, and we are declining to require measurements of hearing loss to establish prospective users' qualification to purchase OTC hearing aids.
OTC category and self-fitting air-conduction hearing aid classification.
We are not requiring that OTC hearing aids be self-fitting devices, and we have provided clarification on the difference between customization and fitting.
Quality System requirements.
OTC hearing aids will be subject to the requirements under part 820 (21 CFR part 820), which describes a quality management system appropriate for medical devices.
We explain those decisions and others, as well as provide our thinking on other topics in the sections that follow.
D. Incorporation by Reference
FDA is incorporating by reference ANSI/CTA-2051, “Personal Sound Amplification Performance Criteria,” dated January 2017, which was approved by the Office of the Federal Register. You may obtain a copy from the Consumer Technology Association (CTA), 1919 S. Eads St., Arlington, VA 22202; https://www.cta.tech, 703-907-7600. Among other things, it describes how to measure frequency response and includes technical data for adaptations for different circumstances and provides a standardized way to quantify frequency response for OTC hearing aids and to meet the related electroacoustic performance requirements.
FDA is also incorporating by reference ANSI/ASA S3.22-2014 (R2020), “Specification of Hearing Aid Characteristics,” dated June 5, 2020, which was approved by the Office of the Federal Register. You may obtain a copy from the Acoustical Society of America (ASA), 1305 Walt Whitman Road, Suite 300, Melville, NY 11747 Telephone: 1 (631) 390-0215, Fax: 1 (631) 923-2875, Email:
asastds@acousticalsociety.org
or the American National Standards Institute (ANSI), 1889 L Street NW, 11th Floor, Washington, DC 20036;
https://www.ansi.org,
202-293-8020. ANSI/ASA S3.22-2014 (R2020) describes tolerances and test methods used for certain measurements of hearing aid performance. The application of ANSI/ASA S3.22-2014 (R2020) provides professional hearing instrument specialists with standardized technical information to help them select the correct hearing aid and ensure optimal fit and performance for hearing aid users.
IV. Legal Authority
The FD&C Act establishes a comprehensive system for the regulation of devices, as defined in section 201(h) of the FD&C Act (21 U.S.C. 321(h)), intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) defines three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for human use and are subject to the FD&C Act. Currently, air-conduction hearing aids are generally either class I or class II devices.
The FD&C Act also directs the establishment of an electronic product radiation control program under section 532(a) to protect the public health and safety (see 21 U.S.C. 360ii(a)), and requires, among other things, that manufacturers of electronic products provide notification of certain defects (see 21 U.S.C. 360
ll
). Section 531(1)(B) of the FD&C Act defines electronic product radiation as, among other phenomena, any sonic, infrasonic, or ultrasonic wave emitted from an electronic product as the result of the operation of an electronic circuit (see 21 U.S.C. 360hh(1)(B)). In turn, any manufactured or assembled product which, when in operation, contains or acts as part of an electronic circuit and emits (or in the absence of effective shielding or other controls would emit) electronic product radiation would be an electronic product (see 21 U.S.C. 360hh(2)(A)). As such, hearing aids and PSAPs emit electronic product radiation and are electronic products, meaning they are subject to the electronic product radiation control requirements.
FDARA amended the FD&C Act to apply requirements specific to certain hearing aids and defined the term “over-the-counter hearing aid” (see 21 U.S.C. 360j(q)). We are issuing these requirements for OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes FDA to establish requirements for labeling, output limits, conditions for sale and distribution of OTC hearing aids, and other requirements that provide for reasonable assurance of safety and effectiveness of these devices.
In addition, the FD&C Act provides that a device is misbranded unless, among other requirements, its labeling bears adequate directions for use (see section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)). Consistent with section 502 of the FD&C Act, FDA has issued regulations that exempt certain kinds of devices from the requirement for adequate directions for use. Section 502(f)(2) further requires adequate warnings against use of a device in those pathological conditions, or by children, where use of the device may be dangerous to health. The labeling must also bear adequate warnings against unsafe dosage or methods or duration of administration or application (see section 502(f)(2) of the FD&C Act). Such warnings must be in such manner and form as are necessary for the protection of the users (see section 502(f)(2) of the FD&C Act).
A device is also misbranded if its labeling is false or misleading in any particular (see section 502(a) of the FD&C Act). Section 201(n) of the FD&C Act states that in determining whether labeling or advertising is misleading, there shall be taken into account not only representations made or suggested but also the extent to which labeling or advertising fails to reveal material facts.
Other misbranding provisions under the FD&C Act would apply as well,
including section 502(c), which deems a device to be misbranded if any word, statement, or other information required by or under authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Additionally, section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act (21 U.S.C. 371(a)). The regulations established in this rulemaking are for the efficient enforcement of the FD&C Act because they will provide standards for the legal marketing of safe and effective hearing aids.
Violations of any final rules from this rulemaking, once in effect, would render the hearing aids adulterated and/or misbranded under sections 501 and/or 502 of the FD&C Act, and subject to enforcement action, for example, seizure (see section 304 of the FD&C Act (21 U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C. 332)), and criminal prosecution (see section 303 of the FD&C Act (21 U.S.C. 333)). Prohibited acts include, among others, introducing an adulterated or misbranded device into interstate commerce (see section 301 of the FD&C Act (21 U.S.C. 331)). Sections 538 and 539 of the FD&C Act additionally set forth prohibited acts and provisions for enforcement for electronic product radiation control (see 21 U.S.C. 360
oo
and 360pp, respectively).
Under section 521 of the FD&C Act, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement that is different from, or in addition to, any requirement applicable under the FD&C Act to the device and that relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C Act also provides that FDA may grant an exemption from preemption under certain circumstances. Section 709(b) of FDARA also includes a preemption provision with respect to requirements for OTC hearing aids.
V. Comments on the Proposed Rule and FDA's Responses
In the proposed rule, FDA welcomed comments on all aspects of the proposal, and we specifically requested comments on certain topics to encourage more-targeted feedback. Such topics included:
the clarity of the definitions and ways to improve them;
labeling requirements;
equitable access to hearing aids and information about them;
whether State or local requirements for returns would promote or restrict or interfere with commercial activities involving OTC hearing aids;
design requirements to limit insertion depth;
proposals for modification of, or alternatives to, the current applicable Quality System requirements for OTC hearing aids;
conditions for sale of OTC hearing aids to prevent sale to or for people younger than 18;
the removal of regulations in 21 CFR part 808 (part 808) regarding exemptions from Federal preemption for State and local requirements respecting hearing aids;
possible effects of the rule on small manufacturers;
data concerning the environmental assessment and our proposal for a finding of no significant impact (FONSI);
topics related to the Paperwork Reduction Act of 1995 (PRA) and associated estimates for recordkeeping burdens; and
potential impacts on Indian Tribes from this rulemaking.
As appropriate, we summarize such comments that we received, along with other pertinent comments, and respond to them in the corresponding subsections that follow. As we indicated in the proposal, we considered only comments submitted to the docket for this rulemaking that were timely and pertinent (see 86 FR 58150-58161).
The vast majority of comments that we received supported rulemaking to encourage wider adoption of safe and effective hearing aids for people who could benefit from them. FDA agrees that rulemaking can encourage wider adoption of such devices, and we expect this final rule to do so. Many commenters conveyed enthusiasm for affordable hearing aids and/or wider availability without the involvement of a licensed person, telling us that they expect the difference to make hearing aids accessible to them—in some cases, for the first time. Some comments observed that hearing impairment often correlates with lower income, suggesting that lower prices may be particularly helpful for people who may want to use hearing aids and that OTC hearing aids could serve an important role in achieving equitable health outcomes.
Still, many commenters voiced both support and concern for the role of licensed persons and the value of professional services for hearing health. In finalizing this rule, FDA is not suggesting that licensed persons or their professional services are unimportant or not valuable. Indeed, we recommend consulting licensed persons in several circumstances, including for the diagnosis of hearing impairment and in the fitting and continued use of OTC hearing aids when consumers choose to seek such services. Many commenters asserted that the professional services are worth the cost. In that vein, one comment suggested that, like providing alternative distribution channels, increasing the number of audiologists and other hearing health care providers would also improve accessibility. This final rule, however, focuses on subjects within FDA's purview, establishing device requirements that provide reasonable assurance of safety and effectiveness for OTC hearing aids without the involvement of a licensed person, as directed by FDARA.
As for specific provisions, the comments generally supported establishing requirements for labeling, output (volume) limits, electroacoustic performance requirements, and other design requirements for OTC hearing aids. However, individual comments varied on the extent to which they supported specific proposals or proffered alternatives. Comments that provided a rationale and/or evidence generally lent more insight for FDA's consideration.
We acknowledge that some comments did not support this rulemaking, many of them stating that hearing aids are medical devices and should not be regulated as consumer electronics. We interpret such comments to mean that OTC hearing aids should not have a relaxed standard for safety or effectiveness, nor should OTC hearing aids be subject to less stringent requirements for product quality than other medical devices. We agree that OTC hearing aids must meet the same standard as other devices for having reasonable assurance of safety and effectiveness, consistent with the FD&C Act and section 709 of FDARA, and that OTC hearing aids be subject to the quality system requirements applicable to other devices. However, we note that different device types and categories will raise different issues related to safety and effectiveness. Thus, while devices must meet the same standard of having reasonable assurance of safety and effectiveness, different device types and categories can engender different regulatory requirements to achieve the same standard. This final rule establishes requirements specific to hearing aids and although the requirements for OTC and prescription hearing aids are not the same, these requirements, along with other applicable requirements under the FD&C Act, provide for reasonable assurance of safety and effectiveness for
both categories of hearing aids (we note that in this document when we describe the requirements in § 800.30 (21 CFR 800.30) or § 801.422 (21 CFR 801.422) as providing reasonable assurance of safety and effectiveness, we mean in conjunction with other applicable requirements under the FD&C Act).
A. Device Classification and Marketing
We received several comments about the interplay among device classification regulations, the OTC Hearing Aid Controls, and premarket notification requirements. Generally, we agree that clarification on such issues will help ensure that manufacturers identify and follow the appropriate regulatory requirements for their devices.
(Comment 1) Multiple comments requested clarification on the difference between self-fitting hearing aids classified under § 874.3325 (21 CFR 874.3325) and hearing aids that, through tools, tests, or software allow users to control the hearing aids and customize them to the users' hearing needs. Many such comments pointed out that the clarification will help manufacturers determine the applicability of premarket notification requirements and special controls.
(Response) Under section 520(q)(1)(A) of the FD&C Act, an OTC hearing aid must be controllable by the user and customizable to the user's hearing needs. We interpret the requirement for customization to hearing needs to mean that the device must allow the user to cause frequency-dependent changes based on the user's preference. This is because a single profile for gain versus frequency is unlikely to accommodate the majority of hearing needs for perceived mild to moderate impairment. For example, a flat gain profile across frequency is unlikely to meet the hearing needs of users with sloping hearing loss, the kind of impairment often associated with aging, as well as a non-flat gain profile across frequency would. However, a flat gain profile across frequency may be preferable for some people with a different kind of hearing loss. In short, to have reasonable assurance of safety and effectiveness of OTC hearing aids, the devices must offer capabilities for a variety of perceived mild to moderate hearing impairments, and customization is the method or process that allows the user to match the device output to individual preference.
We interpret the requirement for user control to mean that the user can access or select the output characteristics most significant to the user's hearing perception. For an OTC hearing aid, we consider these characteristics to include the frequency-dependent output profile and the output volume. The controls must allow the user to select the output volume and profile according to preference. The user may control the output profile, for example, with a physical toggle switch, a selection through a software interface, or providing preferences for software to select the optimal profile dynamically.
FDA views customization as a more-general concept than self-fitting. Fitting is a customization process that instills in the device frequency-dependent settings for the specific user. A self-fitting process instills frequency-dependent settings through the user interacting with the device or an accessory to the device. Self-fitting hearing aids incorporate technology, including software, that integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings (see § 874.3325(a)). A self-fitting strategy is a fitting process, with the selected output profile intended to correspond to the user's audiogram more closely than a hearing aid that is not fitted. Many hearing aids that are customizable but not fitted have a limited set of standardized output profiles, often called “presets.”
In considering whether a hearing aid is self-fitting, FDA takes into account, among other things, the device's design and labeling. For purposes of distinguishing fitting a hearing aid from selecting among standardized output profiles, we focus on the determination and configuration of device settings that would be appropriate for the specific user, especially the frequency-dependent settings. (However, this focus does not exclude other factors that would still be relevant to determining intended use.) For example, a hearing aid outputting a preset likely would not be self-fitting, but a hearing aid that allowed the user to make frequency-dependent modifications to a preset to suit the user's preferences likely would be self-fitting.
FDA recognizes that, because a preset may approach a user's ideal fitting, a device with several presets may be difficult to distinguish from a self-fitting device. However, we note that devices with a small number of presets, for example, three, are not ordinarily considered self-fitting when the user chooses the profile. However, a hearing aid with a greater number of profiles would more closely resemble a fitting process, with the selected output profile intended to correspond to the user's audiogram more closely, in which case the hearing aid likely would be considered self-fitting. Similarly, toggling between a small number of programs, for example, for noise reduction or scene selection, would generally not indicate self-fitting, but setting or adjusting compression knee points in frequency sub-bands, would tend to indicate self-fitting. Moreover, FDA would likely consider a device that includes self-fitting functionality to be self-fitting, regardless of whether the individual user takes advantage of the functionality.
In sum, customization need not entail self-fitting, though self-fitting is a kind of customization. Whether a hearing aid is self-fitting depends on its intended use, which may be shown by, among other things, the device's design and labeling (see § 801.4 (21 CFR 801.4)). Some limited feature sets would not ordinarily cause a device to be a self-fitting hearing aid, while more advanced adjustment capability, especially for frequency-dependent settings, would tend to indicate that the device is a self-fitting hearing aid. FDA has made a minor revision to the requirement to provide specific instructions for use of tools, tests, or software to clarify that such instructions need not always refer to self-fitting; such instructions must include instructions for self-fitting only when the OTC hearing aid is a self-fitting device (see final § 800.30(c)(2)(vii)(B)).
(Comment 2) Many comments urged FDA: to clarify that the definition of OTC hearing aids under section 520(q)(1)(A) of the FD&C Act is synonymous with the identification for self-fitting air-conduction hearing aids under § 874.3325(a); to declare that self-fitting hearing aids are OTC devices; to declare that OTC hearing aids must be self-fitting; and/or to require that OTC hearing aid labeling bear the description “self-fitting” or a similar description.
(Response) Although FDA expects that many OTC hearing aids will be self-fitting, we do not agree with these comments. As explained in the response to Comment 1, a hearing aid may be customizable in the manner required under section 520(q)(1)(A)(iii) of the FD&C Act yet not be intended to entail fitting. Thus, we are not requiring that OTC hearing aids be self-fitting devices.
By extension, we are not requiring in this final rule that OTC hearing aids bear labeling that describes the devices as “self-fitting” or a similar description. However, § 801.61 (21 CFR 801.61) still applies, and this provision requires, among other things, a statement of identity on the principal display panel of an OTC device. (See also the responses to Comment 21, regarding other considerations for self-fitting
capabilities of OTC hearing aids, and Comment 18, regarding identifying and selling OTC hearing aids.)
Moreover, FDA intends that any hearing aid that uses the same fundamental scientific technology as those defined under §§ 874.3300(a) (21 CFR 874.3300(a)), 874.3305 (21 CFR 874.3305), and 874.3325 (21 CFR 874.3325) qualify as an OTC hearing aid (provided it satisfies all other applicable requirements). Some future hearing aid device types may also meet the statutory definition (and satisfy all other applicable requirements) to be available over the counter. Requiring that OTC hearing aids be a currently classified air-conduction hearing aid could have the effect of limiting the OTC category to current technologies rather than allowing the category to extend to new types of hearing aids.
(Comment 3) Some comments requested clarification on what would qualify as “tools, tests, or software” for the purposes of controlling an OTC hearing aid and customizing it to the user's hearing needs. Similar comments requested that FDA clarify which legacy and wireless air-conduction hearing aids would satisfy the customization requirement but not be a self-fitting hearing aid.
(Response) FDA interprets the requirement for tools, tests, or software broadly. We would, for example, consider a device that allows the user to cycle through output profiles with a push-button selector switch and to set the volume with a knob to meet the requirement. Should such a hearing aid be sufficiently customizable, and should it not incorporate wireless or self-fitting technology, then it would presumably be an air-conduction (“legacy”) hearing aid classified under § 874.3300 and could be made available OTC. (See the response to Comment 1 for more about distinguishing customization and fitting.)
(Comment 4) Comments expressed concerns about the potential to bypass premarket notification requirements and special controls if non-self-fitting hearing aids could be later configured or modified, for example, if the manufacturer “unlocks” self-fitting software or provides the user with options for “advanced settings” or the like. They urged FDA to finalize rules to prevent such an outcome.
(Response) Existing requirements already address modifications to devices, including hearing aids. Under § 807.81(a)(3) (21 CFR 807.81(a)(3)), a 510(k) is required if the device is about to be significantly changed or modified, namely, a major change or modification in the intended use or other kind of change or modification that could significantly affect the safety or effectiveness of the device. For example, a change or modification that causes a device to fall within a different classification regulation would be considered significant. Additionally, as explained in the response to Comment 1, aspects of the device's design and labeling can demonstrate the device's intended use (see § 801.4). If a wireless air-conduction hearing aid later incorporates self-fitting technology (for example, by downloading software) or such technology is later made accessible to the user (for example, by “unlocking” after an additional purchase), such a change would almost certainly demonstrate that the modified device was a self-fitting air-conduction hearing aid classified under § 874.3325 (assuming it was not a new device type). As such, it would be subject to the premarket notification requirements and special controls that apply to self-fitting air-conduction hearing aids.
In sum, a change in intended use or other aspect can cause a change in applicable requirements, and a device must comply with applicable regulatory requirements. As such, if a manufacturer intends to unlock or similarly upgrade its hearing aid with self-fitting technology such that it would fall within the self-fitting air-conduction hearing aid classification regulation, then prior to initial introduction into interstate commerce of the device, the manufacturer must comply with applicable requirements, including 510(k) requirements and compliance with the special controls. (See also the response to Comment 6 about the information a 510(k) should include.)
(Comment 5) Several comments requested clarification on when manufacturers of OTC hearing aids would need to submit a premarket notification, also called a 510(k). Many of these comments urged FDA to require 510(k)s for all OTC hearing aids.
(Response) FDA's existing requirements and related policies for submitting 510(k)s apply to hearing aids intended for OTC availability and use. We are not imposing additional general requirements for 510(k)s.
For manufacturers that have already legally introduced self-fitting air-conduction hearing aids into interstate commerce, changes to their devices to satisfy the OTC Hearing Aid Controls may require submission of a 510(k). However, in certain situations FDA intends not to enforce the requirement for a 510(k), as discussed in section VI on effective and compliance dates.
This policy also applies to non-self-fitting devices (wireless air-conduction and legacy air-conduction hearing aids). However, manufacturers of non-self-fitting devices may wish to consider the implications of using a test for somebody besides the user to fit the device. For devices intended for fitting based off of a user-supplied audiogram, a requirement for the involvement of a licensed person to produce the audiogram may cause the device not to be an OTC hearing aid as defined in section 520(q)(1)(A) of the FD&C Act.
Further, if a manufacturer or other non-licensed person obtains hearing ability data to customize (or even fit) a hearing aid, the manufacturer should consider whether the instrument used to obtain the data is a diagnostic (or other) device. Using a hearing aid with a diagnostic device may implicate changes to a hearing aid concerning the compatibility or interoperability with other devices, including other components or accessories, that could significantly affect the hearing aid's risk profile, necessitating a 510(k).
Notwithstanding these general principles, in each case, manufacturers should evaluate any changes in light of FDA's guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” issued October 25, 2017, which describes specific changes that generally do or do not require premarket notification.
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1
The document is available online at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
To illustrate: If a manufacturer of a wireless air-conduction hearing aid updates device labeling and adds a user self-assessment test intending the test to enable the user to independently customize and derive the fitting and settings (the device is intended to entail fitting), then FDA would anticipate the manufacturer would need to submit a 510(k). FDA's guidance document lists several considerations that would likely apply. In this example, the changes included:
the directions for use, including the use and application of the self-test to the device settings (see A4 of the aforementioned guidance on deciding when to submit a 510(k), “Could the change affect the directions for use of the device?”);
the control mechanism and/or operating principle (see B2 of the same guidance, “Is it a control mechanism, operating principle, or energy type change?”);
the device's design, specifically changes to its performance, components
or accessories, and human factors of the interface (see B5 of the same guidance, “Is it any other change in design (
e.g.,
dimensions, performance specifications, wireless communication, components or accessories, or the patient/user interface)?”); and
those that significantly affect its use, potentially necessitating clinical validation data (see B5.1 and B5.3 of the same guidance, “Does the change significantly affect the use of the device?” and “Are clinical data necessary to evaluate safety or effectiveness for purposes of design validation?”).
Each of those changes in this example could require a 510(k), depending on the specifics of the changes. In deciding whether to submit a 510(k), manufacturers may want to review the guidance in its entirety since the considerations for the example are not exhaustive and may or may not be applicable, depending on the specific device. Manufacturers may also want to review FDA's guidance, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” issued October 25, 2017.
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2
The document is available online at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device.
Note that, although a wireless air-conduction hearing aid classified under § 874.3305, or a legacy air-conduction hearing aid classified under § 874.3300, is exempt from requirements for premarket notification, some changes could exceed the limitations of exemption under § 874.9 (21 CFR 874.9), depending on the specifics.
(Comment 6) Commenters requested clear guidance on the specific information manufacturers would need to submit in a 510(k) to bring devices to market quickly, avoiding unnecessary delays or unnecessarily hindering innovation.
(Response) In addition to the required information specified in the 510(k) procedures under 21 CFR part 807, subpart E, the specific information that a manufacturer should submit will vary based on the new device or specific changes made to an existing device. Therefore, providing specific guidance for all manufacturers in this final rule is not feasible. However, FDA's usual policies on the content and format of 510(k)s apply to submissions for hearing aids, including for modifications made to satisfy applicable special controls and the OTC Hearing Aid Controls. Manufacturers may wish to review publicly available information regarding the De Novo classification of self-fitting air-conduction hearing aids. (See the response to Comment 5 regarding when to submit a 510(k).)
In the case of OTC hearing aids, we anticipate that many manufacturers that submit a 510(k) could avail themselves of the Abbreviated 510(k) Program, as described in FDA's guidance of that name, issued on September 13, 2019.
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Should a manufacturer incorporate self-fitting (or other) technology into one of its existing legacy or wireless devices and need to submit a 510(k), we would expect that the manufacturer could leverage the similarity with exempt devices as a least-burdensome way to obtain marketing authorization for the device that is not exempt from premarket notification requirements. Manufacturers of existing devices may not need to re-address questions, for example, related to electromagnetic compatibility (EMC), provided the manufacturer has not made changes that would affect EMC and require a 510(k) under our usual policies. Further, summary reports describing how the hearing aid complies with applicable special controls may be especially useful in addressing clinical data that support the effectiveness of the self-fitting strategy, usability testing, and software verification, validation, and hazard analysis.
3
The document is available online at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/abbreviated-510k-program.
Moreover, manufacturers that have decided to submit a 510(k), whether traditional or abbreviated, may wish to review FDA's guidance, “Format for Traditional and Abbreviated 510(k)s,” issued on September 13, 2019.
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The guidance provides a general framework for the format and content of a 510(k).
4
The document is available online at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-510ks.
(Comment 7) Commenters requested that FDA exempt certain kinds of hearing aids, including self-fitting devices, from premarket notification requirements. Some posited that FDA would accrue sufficient experience with self-fitting air-conduction hearing aids to evaluate the potential for 510(k) exemption 2 years after the effective date of this final rule. Others requested that FDA explain how OTC hearing aids will become 510(k)-exempt.
(Response) FDA's usual policies for exempting devices from premarket notification requirements apply to self-fitting air-conduction hearing aids. Stakeholders may wish to review FDA's guidance, “Procedures for Class II Device Exemptions from Premarket Notification,” issued February 19, 1998.
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The guidance lists several factors that FDA may consider for exemption, including:
5
The document is available online at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
The history (if any) of false or misleading claims or of risks associated with inherent characteristics of the device, such as device design or materials (FDA considers the risks associated with false or misleading claims, and the frequency, persistence, cause, or seriousness of the inherent risks of the device);
How characteristics of the device necessary for its safe and effectiveness performance are well established;
How changes in the device that could affect safety or effectiveness will either be readily detectable or not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment;
How any changes to the device would not be likely to result in a change in the device's classification; and
The role of the limitations of exemption.
Although the amount of time that has passed since the classification of the device in question may affect how FDA views the factors, for example, the history of false or misleading claims, the amount of time since classification is not generally directly relevant. That is, 2 years after the effective date of this final rule may or may not afford sufficient experience and information to exempt all self-fitting air-conduction hearing aids from premarket notification requirements. We did not propose to exempt self-fitting air-conduction hearing aids and are not doing so now (see 86 FR 58150 at 58171).
B. Scope (§ 800.30(a))
We received several comments on which devices should be subject to the OTC Hearing Aid Controls and, conversely, which devices should be prescription. Sometimes these comments referred to definitions rather than scope. In this section, we respond to comments on scope, including comments where the suggested changes to the definitions affect the scope. The next section of this document, specifically for definitions, responds to comments that relate more directly to the clarity of terms or the usefulness of different terms.
(Comment 8) Comments requested clarification on the applicability of the OTC Hearing Aid Controls in circumstances in which software intended for compensation for hearing loss operates or adapts the output of other hearing products such as earbuds or headphones.
(Response) To date, FDA has not classified a device that adapts the output of other hearing products, such as earbuds, to compensate for perceived mild to moderate hearing impairment, including a device that accomplishes this through software. Overall, FDA encourages innovation of hearing products that are safe and effective and, to that end, intends to consider developing guidance to provide clarification on the applicability of laws and regulations implemented by FDA in circumstances where software would operate or adapt the output of hearing products to compensate for perceived mild to moderate hearing impairment. However, considering that in such circumstances, the software might be distributed separately from the hearing product, FDA has added requirements in the OTC Hearing Aid Controls for software device labeling. Similar requirements for software device labeling were also added to § 801.422. (See Additional Revision 3 in section III.D.6 describing the labeling requirements for hearing aid software.
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) The software device labeling requirements take into consideration certain aspects associated with software not distributed with the hearing product, including that such software may not be provided in a package.
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We refer to “additional revisions” to indicate changes that FDA has made in further consideration of comments and the issues involved in this rulemaking, but that are additional to the suggestions made explicitly in comments. We have numbered the Additional Revisions in the order that they appear in this document, which depends upon the subject of the revision—definitions, outside package labeling, etc.—not the order in which the Additional Revisions are cross-referenced in our responses to comments.
(Comment 9) A comment questioned whether a software interface for professionals such as audiologists or hearing instrument specialists would cause a hearing aid to be a prescription device if the professional could adjust the output in excess of the applicable limit.
(Response) If a manufacturer markets an OTC hearing aid that meets the OTC hearing aid definition and complies with all applicable requirements of the OTC Hearing Aid Controls—but also offers an additional separate feature, a software interface for professionals that allows only licensed persons to adjust the device output—FDA likely would not consider the hearing aid to be a prescription device, but the software interface for professionals would be a prescription device and therefore must comply with §§ 801.422 and 801.109. (Note that a software interface for an air-conduction hearing aid, which is the subject of this response, would be distinct from the hypothetical hearing-aid software device, described in the response to Comment 8, that operates or adapts the output of other hearing products such as earbuds or headphones.)
However, the intended use of a device can change after initial introduction into interstate commerce (see § 801.4). If a manufacturer intends prescription uses of a device, the manufacturer should consider how to ensure the device will satisfy all applicable requirements, for example, prescription labeling requirements. Should a manufacturer provide or allow users, and not just licensed persons, ready access to an interface that allows the user to configure the device to provide output in excess of that allowed for OTC hearing aids, this would indicate the device is intended for users (not limited to licensed persons) to set an excessively high output. FDA would be more likely to determine that the intended use was not for perceived mild to moderate hearing impairment. Additionally, such a device would not meet the required output limits in the OTC Hearing Aid Controls. Therefore, such a device would be considered a prescription hearing aid and must meet applicable requirements, including those under §§ 801.422 and 801.109; otherwise, it would be in violation of the FD&C Act.
(Comment 10) Some comments suggested that FDA limit the scope of the OTC Hearing Aid Controls to devices intended only for people with perceived mild, but not moderate, hearing impairment. Some of these comments suggested that perceived moderate hearing impairment requires the involvement of a licensed person for successful treatment, and as such, hearing aids intended for perceived moderate hearing impairment should not be available over the counter.
(Response) FDA disagrees that the involvement of a licensed person is necessary for hearing aids intended for perceived moderate hearing impairment. We are retaining perceived moderate hearing impairment within the scope of the OTC Hearing Aid Controls. The question of whether the involvement of a licensed person would benefit an individual's hearing healthcare is separate from whether the individual would benefit from the use of an OTC hearing aid. In other circumstances, the availability and use of OTC medical products to treat an illness or impairment does not imply the illness or impairment is not serious. Similarly, the availability and use of OTC medical products does not negate the benefit of a licensed person's involvement. FDA considers the use of OTC hearing aids, even when intended for perceived moderate hearing impairment, to be such a set of circumstances.
Further, by statute, OTC hearing aids include devices that are intended to compensate for perceived moderate hearing impairment, and such devices are to be available to consumers over the counter without the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(ii) and (v)). Section 709(b) of FDARA requires FDA to issue regulations that include, among other requirements, provisions for reasonable assurance of safety and effectiveness. This rule will provide reasonable assurance of safety and effectiveness, without the involvement of a licensed person, for OTC hearing aids, including for hearing aids intended for perceived moderate hearing impairment.
Thus, while the involvement of a licensed person may benefit people with perceived hearing impairment, whether of a mild or moderate degree, FDA does not agree that consumers must attempt to obtain such a benefit prior to purchasing hearing aids over the counter. FDA is maintaining perceived moderate hearing impairment within the scope of the OTC Hearing Aid Controls.
(Comment 11) Some comments objected to the inclusion of “perceived” when referring to the kind of hearing impairment for which OTC hearing aids are intended. The commenters express concern that a person's perception of hearing loss may be too subjective, and that the use of OTC hearing aids should be based on more objective measures. Some of the comments suggested that FDA require prospective users to obtain audiograms, which are graphs or test results showing the person's ability to hear different frequencies, from a licensed person prior to purchasing an OTC hearing aid.
Besides obtaining an audiogram, other comments suggested a more general testing or examination requirement by a licensed person for prospective users, prior to purchase. In this way, these commenters suggested, OTC hearing aid users would have more certainty that OTC hearing aids would appropriately compensate for their hearing impairment, and/or the prospective user does not have an underlying, medically treatable cause of hearing impairment, for example, one of the “red flag” conditions. (A “red flag” condition is a sign or symptom that should prompt a consultation with a doctor, preferably an ear-nose-throat doctor.)
(Response) FDA disagrees. We are retaining “perceived” in reference to a
person's degree of hearing impairment and the intended use of OTC hearing aids for legal and policy reasons. The term “perceived” is used in section 520(q)(1)(A)(ii) of the FD&C Act to describe the intended use for OTC hearing aids. Moreover, objective measurements of hearing impairment are not necessary for reasonable assurance of safety and effectiveness of OTC hearing aids.
Relying on perceptions of hearing impairment is also appropriate because the type and degree of impairment exist on a continuum, as does a person's perception and experience of the impairment. A given degree (quantification) of hearing impairment will not necessarily reflect whether an OTC hearing aid is likely to benefit a specific individual. We have therefore focused on communication and other perceptual experiences (such as listening to music) in which an intended user is likely to suspect or notice—that is, to perceive—hearing impairment. FDA expects this approach based on perception to assist users and prospective users better than an approach that does not.
Additionally, while FDA agrees that an audiogram would provide a prospective user with an objective measure of hearing impairment, we do not agree that the scope of the OTC Hearing Aid Controls should include only hearing aids for objectively measured impairments. Such a limitation is counter to the objectives of section 709 of FDARA, including making available hearing aids OTC, without the involvement of a licensed person, to consumers through in-person transactions, by mail, or online.
We acknowledge that this places some onus on users and prospective users. However, this is the case with respect to OTC availability of many medical products, and we are establishing requirements that will provide reasonable assurance of safety and effectiveness for such availability of hearing aids. We also observe that, while an audiogram might help a user or a licensed person tailor the hearing aid, or initially select it, even a hearing health care provider would still ask the user how the device sounds to the user. The user's perception would help the hearing health care provider make further adjustments. A person's desire to seek and use hearing aids depends more directly upon that person's perception of their hearing impairment than the definitive degree of impairment, and even a licensed person fitting and adjusting the device would also account for the user's perception. (See also the response to Comment 24 about defining hearing loss numerically.)
Further, FDA has included information in the labeling requirements for OTC hearing aids intended to help users understand whether the devices are suitable based on their perceptions, realistic expectations for hearing aid use, and suggestions on when to obtain professional assistance before and after purchase. Should prospective OTC hearing aid users still feel uncertain about their perceptions of impairment, notwithstanding the availability of the aforementioned information, they may choose to obtain or undergo professional testing prior to purchase.
(Comment 12) Some commenters suggested that FDA require a prescription for OTC hearing aids.
(Response) FDA disagrees. Requiring a prescription to purchase an OTC hearing aid would be contrary to the purposes of this rulemaking, the definition of OTC hearing aids in the FD&C Act, and FDARA which includes the mandate to establish requirements for hearing aids to be available over the counter (see section 520(q)(1)(A)(v) of the FD&C Act and section 709(b)(1) and (b)(2)(D) of FDARA). It also would negate the probable health benefits created by wider availability of hearing aids, as we described in the proposal (see 86 FR 58150 at 58152).
(Comment 13) Multiple comments suggested FDA remove dispensing from the list of commercial activities that FDA included in the definition of “licensed person.” The definition listed commercial activities involving OTC hearing aids for which a State or locality could not require the involvement of a licensed person. For example, a State could not require a person representing as a dispenser of OTC hearing aids to undertake special licensing or equivalent activities solely for that reason.
Such comments cited various reasons, for example, that State regulatory regimes impose obligations on people representing as dispensers, so referring to the term in the OTC Hearing Aid Controls would create an inconsistency with State regulatory requirements. Other comments pointed out that people expect dispensers to have licenses, and FDA's regulations would be inconsistent with such expectations. Still others cited the need for dispensers to acquire and/or demonstrate qualifications prior to dispensing OTC hearing aids.
Similar comments suggested that FDA instead refer to dispensers as “sellers,” “vendors,” “merchants,” or other such terms. These terms, the comments assert, would distinguish salespeople from hearing health care providers.
(Response) FDA is not modifying the scope of the OTC Hearing Aid Controls or the definition of “licensed person” to exclude dispensing of OTC Hearing Aids. As we explained in the proposed rule, FDARA lists certain activities that may be undertaken with respect to OTC hearing aids for which a State or locality cannot require the involvement of a licensed person (see 86 FR 58150 at 58158). One such activity that FDARA explicitly lists is the dispensing of OTC hearing aids. This means that, under Federal law, a State or locality cannot require a dispenser of OTC hearing aids to undertake special licensing or equivalent activities because that would in essence require the involvement of a licensed person, contrary to section 709(b)(2)(D) of FDARA and section 520(q)(1)(A)(v) of the FD&C Act.
Additionally, in establishing the OTC category for hearing aids, we have developed requirements to provide reasonable assurance of safety and effectiveness for OTC hearing aids without the involvement of a licensed person (see section 709(b)(2) of FDARA). Imposing special licensing requirements or equivalent activities, therefore, is not necessary to provide reasonable assurance of safety and effectiveness of OTC hearing aids. Although not required, a purchaser of OTC hearing aids can still seek the assistance of a licensed person when selecting a hearing aid.
Since a person may dispense OTC hearing aids without a specialized license or the need to involve a licensed person, referring to dispensers by another term such as “vendor” or “seller” is not necessary to distinguish dispensing from activities requiring specialized licensure or the involvement of a licensed person. Moreover, we have previously defined dispensers as persons engaged in the sale, lease, or rental of hearing aids (see prior § 801.420(a)(3)). The regulations we are finalizing in this rulemaking use essentially the same definition. In sum, using alternative titles for dispensers may serve to confuse consumers by unnecessarily establishing another term for a legally permissible activity as well as incorrectly implying that FDA's interpretation of the term has changed.
FDA recognizes that State and local requirements sometimes incorporate the term “dispenser,” and multiple States impose requirements on account of dispensing hearing aids. However, FDARA section 709(b)(4), to summarize, provides that no State or local government shall continue in effect certain State or local requirements that are different from, in addition to, or otherwise not identical to the
regulations issued under FDARA section 709(b). Thus, regardless of whether a State or locality amends or otherwise updates its requirements, it may not continue in effect the inconsistent requirements prior to their amendment or repeal.
As we explained in the proposal, despite the fact that licensure is not required for dispensing OTC hearing aids, some persons may voluntarily identify as a “licensed dispenser,” (see 86 FR 58150 at 58168). Although a State or locality could not require dispensers (or other persons) to undertake special licensing solely on account of commercial activity involving OTC hearing aids, a State or locality could still establish licensure criteria that would apply to those voluntarily identifying as licensed persons. In such a case, the dispenser's identification as a licensed person would imply that the dispenser complies with applicable State or local licensing requirements, albeit voluntarily. (See also the responses to Comment 15, discussing other licensing considerations, and Comment 127, discussing the involvement of a licensed person for prescription hearing aids.)
In sum, in light of Federal statutory and other requirements, including those that provide reasonable assurance of safety and effectiveness of OTC hearing aids, FDA is not narrowing the scope of the OTC Hearing Aid Controls to exclude dispensing. This does not, however, prevent dispensers of OTC hearing aids from voluntarily subjecting themselves to State or local licensing requirements to obtain a license (or its equivalent).
(Comment 14) Comments suggested that OTC hearing aids be available for all degrees of hearing impairment, including degrees greater than moderate. Some of these comments further noted that Medicare does not currently pay for or reimburse the cost of hearing aids. As such, the comments asserted that OTC hearing aids should be usable as lower-cost alternatives to prescription hearing aids for individuals with more-profound impairments.
(Response) For the reasons explained in the response to Comment 10, FDA is establishing requirements for perceived mild to moderate hearing impairment. Thus, the appropriate device output limit that we are establishing would not extend to hearing impairment that would require a greater output than that which is appropriate for perceived moderate hearing impairment.
However, devices of the same type may generally be intended either for prescription or OTC use. For example, a manufacturer marketing an OTC wireless hearing aid could also market another wireless hearing aid with a higher output than that permitted for OTC hearing aids. This higher output would render it a prescription device. As with other products that have differing uses but share manufacturing similarities, a hearing aid manufacturer may be able to realize economies of scale by selling an OTC version and a prescription version of hearing aids that fall within the same type, which in turn could lower the prices for prescription hearing aids. (See also the response to Comment 17 about limitations on FDA's authority to require reimbursement for devices.)
(Comment 15) Some comments suggested FDA define which activities involving hearing aids would require licensure.
(Response) FDA does not generally determine which activities involving medical products require licensure. However, section 709(b)(4) of FDARA lists several activities for which States or localities may not require specialized licensure for, or the involvement of a licensed person in, commercial activity involving OTC hearing aids. These listed activities are the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online. As we explained in the proposal, we interpret the listed activities broadly, so for example, the term “sale” would include leases or rentals (see 86 FR 58150 at 58165).
States usually determine the requirements for licensure or the involvement of licensed persons. States may still do so with respect to hearing aids when not prohibited by section 709(b)(4) of FDARA (and other applicable laws). Where section 709(b)(4) of FDARA does not list an activity, when construing the terms broadly, a State may require licensure for that activity as it relates to OTC hearing aids. We note that the proposal provided a discussion and some examples (see 86 FR 58150 at 58167-58168). Thus, for example, a State may require a license for a hearing aid fitter, because “fitting” is not listed among the activities in section 709(b)(4) of FDARA, and we do not interpret any of the listed activities to include fitting. A person could not be a fitter in that State, even for OTC hearing aids, without a license. However, the State could not require a hearing aid fitting prior to a user purchasing an OTC hearing aid because that would restrict or interfere with commercial activity involving OTC hearing aids. See the response to Comment 13 for further explanation.
Thus, a State may still establish criteria for licensing dispensers should a person voluntarily decide to become a licensed dispenser of OTC hearing aids. In other words, although a State cannot require a license for dispensing OTC hearing aids, a State can establish what a person must do to obtain, and claim to have, a license for dispensing hearing aids. FDA expects that States may wish to continue in effect licensing requirements to dispense prescription hearing aids, and we expect that some hearing aid dispensers may wish to obtain a license in the event they desire to advertise as “licensed” and/or to sell prescription hearing aids in addition to OTC hearing aids.
(Comment 16) Some comments urged FDA to limit the scope of OTC availability as much as possible, at least in the beginning. These comments conveyed concerns for the absence of a licensed person in various roles, including education and counseling. One such comment suggested that a more-limited scope would be easier to broaden later than the reverse, limiting a broader scope.
(Response) In the proposed rule, we explained that several barriers likely impede people's access to hearing aids, including among others, Federal and State regulatory requirements (see 86 FR 58150 at 58152, 58154). We are undertaking this rulemaking in part to remove or reduce such barriers to access by establishing requirements that will provide reasonable assurance of safety and effectiveness while encouraging broad availability (see 86 FR 58150 at 58158). Moreover, we received a wealth of thoughtful and nuanced comments about the scope of the OTC Hearing Aid Controls, including this Comment, and we have determined that a more-restrictive approach is not necessary for reasonable assurance of safety and effectiveness of OTC hearing aids. Considering our purpose to broaden access and our determinations regarding reasonable assurance of safety and effectiveness, we do not agree that narrowing the scope of the OTC Hearing Aid Controls, with the intention of considering a broader scope later, is currently an appropriate strategy.
(Comment 17) Some comments noted the role of health insurers, including Medicare, in a person's ability to obtain hearing aids. Comments suggested that FDA focus on payments or reimbursements for hearing aids, potentially including financial incentives.
(Response) FDA does not have authority to require payors to pay for or reimburse the cost of hearing aids or to offer financial incentives to obtain the
devices. However, we intend this rule, among other ends, to broaden access to hearing aids by eliminating certain kinds of requirements that likely add to the cost of accessing the devices. For example, we are establishing rules to make OTC hearing aids available without the involvement of a licensed person.
C. Definitions (§§ 800.30(b) and 801.422(b))
This section focuses on explaining the final definitions. Generally, commenters sought clarity, and we have generally accepted or declined suggestions with the goal of improving clarity of the definitions.
(Comment 18) Multiple comments proposed that FDA use another name to identify OTC hearing aids. For example, some comments proposed “over-the-counter hearing device,” “self-fit over-the-counter hearing device,” “hearing amplifiers,” and “hearing devices.” Generally, these commenters sought to avoid confusion with existing devices for both consumers and State regulators. Otherwise, commenters believed, consumers may be misled into believing that OTC hearing aids are equivalent to prescription hearing aids with respect to performance, safety, and effectiveness, and there may be regulatory issues for State licensing boards. Other comments argued that the availability of OTC devices through retailers such as grocery or department stores would suggest that these devices are not hearing aids, so referring to them as such would be inappropriate.
By identifying OTC hearing aids in a different way, consumers, regulators, and other stakeholders would, the comments argued, have a clearer indication of devices subject to the new regulatory category. Many such comments noted that the use of a term other than “hearing aid” was recommended by the National Academies of Sciences, Engineering, and Medicine (NASEM) in their report, “Hearing Health Care for Adults: Priorities for Improving Access and Affordability,” and by the Hearing Care Associations in their Consensus Paper, “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness” (Ref. 7).
(Response) FDA will continue to use the term “hearing aids” to refer to the OTC and prescription devices subject to this rulemaking because the use of this term is appropriate. Hearing aids, whether OTC or prescription, are wearable sound-amplifying devices intended to compensate for impaired hearing. The term “hearing aid” describes several device types reflected in various classification regulations. Although OTC hearing aids use air-conduction technology, prescription hearing aids may do so as well (for example, an air-conduction hearing aid that provides a higher output than that specified in the OTC Hearing Aid Controls would be prescription). Therefore, the use of the term “hearing aid” is appropriate to reflect both OTC and prescription devices that fall within the same device type (for example, wireless air-conduction hearing aids under § 874.3305). Moreover, section 520(q)(1)(A) of the FD&C Act explicitly uses and defines the term “over-the-counter hearing aid[s],” and section 709(b)(1) of FDARA requires the establishment of “a category of over-the-counter hearing aids.” Thus, referring to the devices by a different name would not only be inconsistent with the applicable classification regulations and statutes, but also FDA expects that doing so would cause confusion and uncertainty for consumers considering purchasing an OTC hearing aid.
Further, we expect this rulemaking to broaden the kinds of retailers that sell OTC hearing aids, helping to increase the availability of the devices. By extension, the availability of OTC hearing aids (by that name) in grocery and department stores would help fulfill one of the purposes of this final rule. Moreover, many technologically similar products are available and go by several names, including “personal amplifier.” Based on their intended use(s), some of these may not be devices and/or meet applicable requirements for devices, yet they may appear to some prospective purchasers to be suitable alternatives to safe and effective devices.
7
We expect that consumers are familiar with the name “hearing aid,” and using that name will better support broadened use of the devices. At the same time, we expect that introducing yet another name for a similar technology, albeit regulated as a device, would only serve to increase confusion in the marketplace because prospective purchasers may think that a hearing aid could be marketed under other names, including those used for products that do not meet applicable device requirements. Thus, we have determined that the best way to indicate whether the device is subject to this rulemaking is to use the name “hearing aid” as used for the device types in the applicable classification regulations, and the name that is established in the FD&C Act and FDARA, OTC hearing aids.
7
FDA is finalizing a guidance alongside this rulemaking to help stakeholders distinguish hearing aids from PSAPs. To summarize, a PSAP is an electronic product intended for non-hearing-impaired people to amplify sounds in certain environments. A PSAP is not intended to aid with or compensate for impaired hearing.
To assist consumers further, as well as ease determining the applicability of the OTC Hearing Aid Controls, we are modifying the labeling and conditions for sale for OTC hearing aids. See Additional Revisions 2 (section III.D.3) and 4 (section III.G), respectively, for further explanation.
Although the technical specifications are different for OTC hearing aids and prescription hearing aids, as explained elsewhere in this document, FDA believes the technical specifications for each category are appropriate. Additionally, information on the technical specifications is required to be provided in the device labeling. FDA believes that OTC hearing aids that comply with § 800.30 and other applicable requirements (for example, Quality System requirements) will have reasonable assurance of safety and effectiveness for people aged 18 and older with perceived mild to moderate hearing impairment.
(Comment 19) A comment suggested that the definition of “hearing aid” should include an explicit statement that PSAPs are not hearing aids. The comment mentioned the draft guidance we are finalizing concurrently with this final rule, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,” which is published elsewhere in this issue of the
Federal Register
and is also available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products,
and characterized the draft of the guidance as “provid[ing] essential distinctions between [hearing aids] and PSAPs.”
(Response) FDA agrees that distinguishing between hearing aids (devices) and PSAPs (non-devices) can be an important interest for purchasers, manufacturers, and other stakeholders. We are finalizing requirements for the principal display panel on the package of an OTC hearing aid to bear the marks “OTC” and “hearing aid” (see Additional Revision 2 in section III.D.3). We are also finalizing a corresponding condition for sale that sellers may only make a hearing aid available OTC when its package bears the requisite marks (see Additional Revision 4 in section III.G). Moreover, we are finalizing the aforementioned draft guidance document, intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.
We are not, however, modifying the definition of “hearing aid” to state that PSAPs are not hearing aids. As we explained in the proposed rule, the name of a product on its own would not ordinarily demonstrate intended use (86 FR 58150 at 58154). Thus, merely excluding PSAPs from the definition of hearing aid does not remove a product from device regulation under the FD&C Act if, for example, its labeling demonstrated that the product was intended to compensate for hearing loss. We think the actions we are taking will better assist stakeholders to distinguish between products than modifying the definition of “hearing aid” in the OTC Hearing Aid Controls.
(Comment 20) Some comments suggested adding definitions to the classification regulation for self-fitting hearing aids (§ 874.3325). For example, comments suggested FDA define “programming the hearing aid” and “self-fitting strategy.”
(Response) FDA is not adding definitions for purposes of the self-fitting air-conduction hearing aid classification at this time. In considering possible definitions to add, including those suggested in the comments, we sought to balance clarity with flexibility. The phrasing of § 874.3325(a) is intended to cover a range of technologies, both present and future, without unduly constraining innovation. For example, the regulation refers to a “self-fitting strategy,” rather than a more prescriptive description. Under this regulation, manufacturers could choose different strategies to achieve self-fitting by the user while still being substantially equivalent to other devices of the same type. After considering the comments, we have decided not to constrain the classification further.
However, we recognize that these commenters desired to clarify the classification of different types of air-conduction hearing aids, including the applicability of special controls and premarket notification requirements. We have provided our thinking and expectations in section V.A. of this document to address such concerns. Further, FDA may issue guidance on this subject in the future following our Good Guidance Practices and inviting additional comments (see 21 CFR 10.115).
(Comment 21) Several comments requested that FDA define self-fitting hearing aids in such a way as to clarify that the devices must be manipulable by the general public. Many of these comments showed concern about predatory business practices, through which manufacturers might prevent users from customizing device output, because they did not view self-fitting capability as clearly required for OTC hearing aids.
(Response) FDA agrees that OTC hearing aids must be somehow manipulable by lay users; however, we are not adopting these suggestions.
As explained in the response to Comment 1, not all OTC hearing aids are self-fitting devices classified under § 874.3325. Thus, FDA declines to define self-fitting hearing aids in the way suggested by comments.
Further, modifying the self-fitting hearing aid classification regulation in the suggested way is not necessary. By definition, self-fitting air-conduction hearing aids allow
users
to program their hearing aids, and the devices integrate user input with a
self
-fitting strategy and enable users to
independently
derive and customize their hearing aid fitting and settings. Should users themselves be unable to derive or customize the fitting and settings independently, or program their hearing aids, FDA likely would not consider it a self-fitting air-conduction hearing aid.
More generally, section 520(q)(1)(A)(iii) the FD&C Act defines an OTC hearing aid, in part, as a device that allows the
user
to control the hearing aid and customize it to the user's hearing needs. Should users of a hearing aid be unable to control and customize the device in the manner required, the hearing aid would not be an OTC hearing aid as defined in the FD&C Act or final § 800.30, and thus, would be a prescription device.
FDA also notes that the FD&C Act, the OTC Hearing Aid Controls, and the classification regulation for self-fitting air-conduction hearing aids all refer to the “user” of the hearing aid. Referring to manipulation by the general public may not accurately or adequately represent the intended user(s) of a hearing aid because the intended user(s) may differ in significant ways from the general population. However, FDA agrees that manufacturers should generally assume that users are laypeople (not experts) regarding OTC hearing aids, and we are finalizing the definition of “tools, tests, or software” as proposed. The definition specifically requires that a lay user be able to control and customize an OTC hearing aid. Further, because OTC hearing aids are not prescription devices (and are not otherwise exempt from certain labeling requirements), the labeling must include adequate directions for use, which are directions under which a layperson can use the device safely and for its intended use(s) (see § 801.5 (21 CFR 801.5)).
(Comment 22) A comment suggested that FDA explicitly require that users have control of the device output to customize the device to their hearing needs. This comment argued the phrasing of the definition for “tools, tests, or software” that FDA proposed is ambiguous, potentially allowing manufacturers to restrict control of the device to physical fit but not the sound output.
(Response) As explained in the response to Comment 21, section 520(q)(1)(A)(iii) of the FD&C Act defines an OTC hearing aid as a device that, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user's hearing needs. In final § 800.30(b), we define “tools, tests, or software” as components that allow lay users to control the device and customize the device
sufficiently.
As explained in the response to Comment 1, we interpret the requirement for customization to hearing needs to mean that the device must allow the user to cause frequency-dependent changes based on the user's preference, and the requirement for user control to mean that the user can access or select the output characteristics most significant to the user's hearing perception. These elements sufficiently describe the requisite controllability and customization without unnecessarily constraining future technologies that could be available OTC. We are not modifying the OTC Hearing Aid Controls as suggested. However, as explained elsewhere in this document, we added a user-adjustable volume control to the design requirements for OTC hearing aids so users will be able to control this aspect of the sound output.
(Comment 23) Comments suggested that FDA include in the definition of “used hearing aid” a stipulation that a bona fide hearing aid evaluation extend through a trial period that might last as long as 90 days. That is, a device would not be considered a “used hearing aid” solely because a prospective purchaser wore it for an extended trial period, without the presence of the dispenser or a hearing health professional selected by the dispenser.
(Response) FDA is not adopting this suggestion because purchasers should be aware of use of the device outside of observation to ensure appropriate operating conditions. This is because a device will be in contact with the ultimate user's skin for extended periods, and the device contains sensitive electronics. Without observation, a device that a prospective
user is evaluating may be used in a way that would make the device unsanitary for the ultimate user, or the device could have been subjected to damaging conditions.
However, we are revising the definitions and labeling requirements to clarify labeling terms to convey information better. If a manufacturer inspects and tests a used hearing aid, makes any necessary modifications to the hearing aid to ensure it satisfies applicable requirements to be available OTC, including for labeling, electroacoustic performance, and design, and the manufacturer has adequately reprocessed the hearing aid for the next user, then the manufacturer may describe the device as “rebuilt” in the required labeling rather than “used.”
(Comment 24) Multiple comments proposed that FDA define mild to moderate hearing impairment in terms of objective criteria. For example, these comments suggested that FDA adopt thresholds used by the American Speech-Language-Hearing Association (ASHA) or the World Health Organization (WHO) to categorize hearing impairment. Others suggested more generally that labeling describe hearing impairment in detail so that prospective OTC hearing aid users would “understand exactly” their degree of hearing impairment.
(Response) FDA is declining to define hearing impairment for purposes of the OTC Hearing Aid Controls in terms of objective measurements because defining hearing impairment in such a way is neither necessary for, nor consistent with, establishing an OTC category of hearing aids.
Inconsistency would arise because the requirements to establish the OTC category focus on the hearing aid user's perception as well as making devices available without the involvement of a licensed person. Specifically, section 520(q)(1)(A)(ii) of the FD&C Act refers to “perceived” impairment in defining the intended use of OTC hearing aids. As explained in the response to Comment 11, the subjective nature of hearing impairment is integral to the regulatory category we must establish for OTC hearing aids.
Further, an objective definition based on measurement of hearing impairment would imply the need to involve a licensed person, such as an audiologist or hearing instrument specialist, to administer a test or otherwise provide an exact understanding. However, OTC hearing aids must be available without the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(v)), and FDA has determined that an objective measurement of hearing impairment is not necessary for reasonable assurance of safety and effectiveness of OTC hearing aids. Thus, defining the degrees of impairment in objective terms, using one of several available schemes for categorization, would be contrary to the purposes of this final rule as well as unnecessary.
We acknowledge that many licensed persons use audiometric threshold-based hearing loss categories to describe hearing loss severity, and this information may be useful to OTC hearing aid users should they choose to seek it out. However, the perception of hearing difficulties is on a continuum that is not confined to specific audiometric threshold categories. For example, two people with the same audiometric thresholds may have different subjective perceptions of, and different personal preferences for addressing, the impairment. The intended user population will have a broad range of perceptual difficulties and communicative function because of the wide variability and overlap in perception of hearing impairment within and across hearing loss severity.
The ASHA and WHO hearing loss categories each reflect a continuum while providing high-level clinical guidance. These categories do not represent discrete perceptual boundaries for the patient or for the treating professional. Furthermore, these hearing loss categories were not formulated to determine regulatory questions such as whether an individual should have access to OTC hearing aids. We are declining to adapt and apply such a scheme in that way.
Nonetheless, we are establishing labeling requirements to help consumers recognize perceived mild to moderate hearing impairment. See the response to Comment 35 for more on this topic. Further, the labeling encourages users and prospective users to seek professional services in several circumstances, and people who wish to measure their degree of hearing impairment objectively or definitively may still obtain such measurements voluntarily.
(Comment 25) One comment suggested that the definition of “prescription hearing aid” be revised to further state that these devices are dispensed by a State-licensed professional.
(Response) FDA declines to revise the definition of “prescription hearing aid” as suggested because it is unnecessary. Prescription hearing aids are prescription devices and as such, they are subject to § 801.109. Under § 801.109(a), a prescription device is a device that is: (1) either in the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device or in the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device and (2) is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice. Because prescription hearing aids are required to be in the possession of persons lawfully engaged in the retail distribution (or certain other activities) of such devices, and must be sold only to or on the prescription or other order of a licensed practitioner, the revision suggested in the comment is unnecessary.
(Additional Revision 1) After further consideration, FDA is modifying the definition of “dispenser” for the purposes of prescription hearing aids under final § 801.422(b). FDA proposed that the term refer to any person engaged in the sale of prescription hearing aids. However, we observed a potential for confusion based on comments we received, because a person engaged in the sale of OTC hearing aids would also be a dispenser. Thus, while the definition of the term in § 801.422(b) is for the purposes of prescription hearing aid labeling, the definition as proposed may have appeared to create an inconsistency with the use of the term outside of § 801.422. To avoid the potential inconsistency and confusion, we are removing “prescription” from the final definition of “dispenser.”
D. Labeling (§ 800.30(c))
FDA received many comments related to labeling for OTC hearing aids. Most of these comments focused on ensuring the information would be easy to understand for most people, that is, people who are not professionals in a field related to hearing impairment. Commenters suggested various means to improve the labeling, including different phrasing, formatting, or positioning. Others provided general feedback and emphasized Plain Language principles, and a need to avoid jargon or overly technical phrasing, to help readers understand information in the labeling. FDA agrees that Plain Language principles apply in the case of labeling for hearing aid users, and that Plain Language will help users to understand the information in the device labeling.
1. User-Friendly Labeling
(Comment 26) Some comments expressed concern that FDA did not validate the labeling of the OTC hearing aids. Many of these comments are concerned that without labeling validation, a consumer's ability to self-diagnose their hearing loss will be hindered. These comments suggested that a requirement for manufacturers to validate labeling will help to ensure that users can properly self-diagnose their hearing loss.
(Response) FDA is declining to adopt labeling validation requirements for OTC hearing aids at this time. The labeling requirements we are finalizing benefitted from extensive input from many sources, including docket comments and public workshops, such as the one convened by NASEM. Additionally, self-fitting air-conduction hearings aids under § 874.3325 are subject to a special control requiring usability testing, which inherently includes testing the directions for use by the user. Further, any device must have labeling bearing adequate directions for use unless subject to an exemption (see section 502(f)(1) of the FD&C Act and § 801.5). This means that the directions for use for an OTC hearing aid must allow a lay user to use the device safely and for its intended purposes (see § 801.5). Given these requirements, and the extensive input we have received for labeling, a requirement for additional validation is not needed for reasonable assurance of safety and effectiveness.
(Comment 27) Multiple comments proposed that labeling refer to an “Ear-Nose-Throat Doctor,” “ENT,” or similar terms instead of referring to an “ear specialist.” These comments suggested that “ear specialist” is not specific enough because it might imply somebody besides a physician. For example, it could refer to an audiologist or a hearing aid dispenser, neither of whom need be a physician. As such, “ear specialist” may confuse or inadvertently mislead hearing aid users.
(Response) FDA agrees that “ear-nose-throat doctor” and “ENT” are more descriptive and likely more common than “ear specialist.” We have revised labeling throughout to adopt this suggestion when referring to physicians.
(Comment 28) A comment suggested that labeling refer to “physicians” rather than “doctors” because people who are not physicians may be doctors, for example, people who hold Ph.D.s (philosophical doctors) or chiropractors (some of whom are doctors of chiropractic).
(Response) We are not adopting this suggestion. We are adopting suggestions to refer to “ear-nose-throat doctors” instead of “ear specialists” to provide better guidance to people who may be unfamiliar with hearing healthcare delivery (see the response to Comment 27). However, we do not expect that people will seek the assistance of philosophical doctors or chiropractors for their hearing needs just because the labeling for OTC hearing aids refers to a “doctor” rather than a “physician.” Instead, we expect people who seek the assistance of a doctor for their hearing needs will exercise reasonable judgment in discerning which kind of doctor might help them with their hearing needs, in the same way they might exercise reasonable judgment to find appropriate providers when suggested by OTC labeling for other health concerns.
(Comment 29) A comment requested that “doctor” and “physician” in the labeling be revised to “licensed healthcare practitioner.” The comment argued that use of “licensed healthcare practitioner” is consistent with FDARA and would ensure that patients see qualified individuals, yet not confuse and limit consumers about whom they can consult.
(Response) FDA is declining to replace all references to “doctor” or “physician” with “licensed healthcare practitioner” because there are certain aspects of hearing care where it is warranted that a patient consult a “doctor.” As discussed in the response to Comment 27, FDA is updating the term “ear specialist” to “ear-nose-throat doctor (ENT)” to avoid confusion as to whom a consumer should consult. Where FDA now uses the term “ENT” it is to clarify who is best positioned for a patient to consult on a particular matter. For example, an ENT would generally be the kind of provider who has the necessary qualifications and expertise to conduct an examination for the diagnosis of Red Flag conditions. We acknowledge, however, that not all hearing healthcare providers need to be physicians and there are many situations, such as consumers continuing to have difficulty hearing even after beginning use of OTC hearing aids, where consulting licensed healthcare providers would be necessary or appropriate.
(Comment 30) A few comments recommended rewording the “red flag” condition warnings to present the issue first and then the solution. Comments suggested the warning should be updated to read, “[p]rior to purchasing this device, if you have any of the following you should promptly consult with a licensed physician, preferably, an Ear-Nose-Throat (ENT) doctor.”
(Response) FDA agrees that a different presentation would more effectively communicate the warning. In response to comments proposing rewording to increase readability, we have retitled the warning and reordered the introduction in the manner suggested and adopted slightly different phrasing that we think will be more user-friendly.
(Comment 31) A comment expressed concern about the caution that hearing aids are not hearing protection. Some comments argued that it is impracticable for hearing aid users to take out their hearing aids in situations where a loud sound is passing by. Comments recommended the caution be updated to advise individuals to mute or turn off their hearing aids when experiencing a loud sound and only recommend removal of hearing aids if the hearing aid does not provide any hearing protection.
(Response) FDA is declining to implement this revision. FDA has included information in the labeling requirements to help users have realistic expectations when using hearing aids. This particular caution is intended to assist users in the day-to-day use of their hearing aid and to notify them that they should not rely on their hearing aid for hearing protection. Additionally, the labeling includes a caution that individuals should turn down the volume or remove the device if the sound is uncomfortably loud or painful. These two cautions provide appropriate guidance to help ensure safety when experiencing a loud sound.
(Comment 32) A few comments requested revisions to the note regarding expectations about what a hearing aid can do to use more positive framing. Comments argued that the note was more a notice of what hearing aids cannot do, and a more positive framing would increase readability and product desirability.
(Response) FDA agrees that it is important for users to read and understand the labeling easily, and we have updated the note to include language about the benefits as well as limitations of OTC hearing aids. The language was further updated to provide notice that users may need to wait a few weeks to get used to their hearing aids.
(Comment 33) A few comments requested that FDA require a minimum font size so that consumers can read and understand the particulars of each OTC hearing aid. Comments recommended requiring font sizes from 12-14 points.
(Response) FDA is declining to implement this suggestion. This rule applies to a large number of manufacturers and their various hearing aids so FDA believes some flexibility is
warranted. Additionally, we do not believe a minimum font size is necessary to ensure users can read and understand the labeling for OTC hearing aids because there are requirements that address this. For example, under section 502(c) of the FD&C Act, a device is misbranded if any word, statement, or other information required by or under authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use (see 21 U.S.C. 352(c)). Given this and other requirements, and the need for some flexibility as the rule applies to a variety of devices, FDA does not believe a minimum font size is warranted.
(Comment 34) A few comments recommended that the descriptions of functions of the hearing aids include figures and videos alongside text to provide additional clarity on how to use hearing aids.
(Response) To help users after purchase, the inside labeling must include, among other information, a description of accessories; illustration(s) of the OTC hearing aid that indicates operating controls, user adjustments, and battery compartment; adequate directions for use; technical specifications; and a description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid. The labeling requirements will allow a lay user to use the device safely and for its intended purposes (see § 801.5). The additions suggested by comments are not necessary for reasonable assurance of safety and effectiveness.
2. User Education
(Comment 35) A comment suggested that device package labeling describe hearing impairment in terms of common perceptual difficulties. In specific, it proposed that labeling describe mild impairment as having difficulty hearing soft-spoken people and young children. According to the comment, people with mild impairment are often able to hear loud or more-intense vowel sounds but may miss some of the softer consonant sounds. Thus, they may have to ask people to speak up or repeat themselves on occasion. The comment further stated that for someone with typical hearing, this is comparable to placing a finger in one's ears.
The comment proposed that labeling describe moderate impairment as having additional difficulty hearing vowel sounds in addition to missing consonant sounds. According to the comment, this means that when someone is speaking at a normal volume, a person with moderate hearing impairment is unable to hear most of the speech sounds. Accordingly, people with moderate hearing impairment often comment that they hear sounds but cannot always understand speech.
(Response) To help users determine whether they have perceived mild to moderate hearing impairment, FDA has revised the package labeling requirements by simplifying the language and making it less formal. (See the response to Comment 41 for more about these revisions.) However, while we agree that the suggested descriptions may also be useful for prospective users, other factors impact determining the labeling requirements. These factors include, for example, the limited space available for the outside package labeling, as many comments emphasized, and whether the information is necessary to provide reasonable assurance of safety and effectiveness. The descriptions suggested in the comment would add to the length of the material on the outside packaging for OTC hearing aids. Additionally, the required information under final § 800.30(c)(1)(B) sufficiently helps to provide reasonable assurance of safety and effectiveness, without the addition of the suggested text, because it contains enough information for someone to identify whether an OTC hearing aid may be intended for their particular hearing impairment. Therefore, we are not revising this final rule in the way suggested by the comment.
However, as stated above, the additional information described in the comment may still be useful so we intend to add similar information to FDA's website, which has pages focused on hearing aids and hearing loss. You can access the main web page at:
https://www.fda.gov/medical-devices/consumer-products/hearing-aids.
You may also wish to review information from the National Institute on Deafness and Other Communication Disorders. You can access their web pages at:
https://www.nidcd.nih.gov/health/hearing-ear-infections-deafness.
These websites provide more information for people interested in learning about hearing aids and hearing loss.
(Comment 36) A few comments expressed concern that, without proper warnings on the label, purchasers would not be informed on the limitations of OTC hearing aids with regard to their degree of hearing impairment.
(Response) FDA agrees and is finalizing the clear statement that we proposed, with an updated, more user-friendly list of common symptoms of mild to moderate hearing impairment. We are also finalizing the requirement, with similarly improved language, that the labeling describe signs of more severe impairment.
(Comment 37) A few comments expressed concern about the statement that hearing aids will not restore normal hearing and that training and counseling from a hearing healthcare professional may increase satisfaction. Comments argued that these ideas are based upon current limitations of hearing aids and recommended the statement be removed because, they argued, future hearing aids may have the capability to restore hearing to a normal level.
(Response) FDA is declining to remove this statement. The note informs consumers of the limitations and benefits they should expect from an OTC hearing aid. Since many purchasers will be selecting and using OTC hearing aids without the involvement of a licensed person, FDA has included statements, including the one discussed above, to help consumers have realistic expectations about OTC hearing aids. This helps provide reasonable assurance of safety and effectiveness.
(Comment 38) A few comments requested that labeling include a warning of when to stop use of OTC hearings aids. The comments expressed concerns that some hearing aid users may be unaware that they should stop use of OTC hearing aids due to the onset of certain conditions, for example, ear drainage, pain, and balance issues.
(Response) FDA agrees that certain conditions should suggest that users consult with a hearing healthcare provider, but we do not agree that the onset of such conditions necessarily indicates the user should stop using OTC hearing aids. FDA has revised the labeling to make it more general so that it warns users to see a doctor, preferably an ear-nose-throat doctor, if the user experiences any of the listed problems before or after purchase.
(Comment 39) A few comments recommended an additional warning on the inside package labeling to alert individuals that there is potential harm when wearing hearing aids for longer than recommended. Comments proposed a warning to users to exercise special care in the use of the device. It would warn against use of the hearing aid for more than 12 hours a day, for example, and against use if the device becomes uncomfortable, either due to the loudness of sound or the physical fit of the device. Such proposed warnings sought to mitigate the risk of further
impairment if the device was set to the maximum output level and worn for periods of time exceeding these recommendations.
(Response) FDA is declining to implement such suggestions. OTC hearing aids are designed to be worn all waking hours in a variety of listening environments and situations. The labeling required in this rule provides reasonable assurance of safety and effectiveness, including through notices that the hearing aid sound output should be neither uncomfortable nor painful, and that the hearing aid should not cause pain or discomfort when inserting or placing it.
(Comment 40) A few comments expressed concern that the labeling lacked reference to how a hearing healthcare professional can assist and benefit a person purchasing an OTC hearing aid. Comments recommended FDA develop labeling that includes guidance that, due to their specialized knowledge, hearing healthcare professionals are better at assisting in hearing tests and maximizing the benefits of a hearing aid.
(Response) FDA declines to make this addition to the labeling. This rule includes requiring specific language to assist consumers in determining whether an OTC hearing aid best meets their needs and when to consult a licensed professional. As mandated by FDARA, this rule establishes requirements to provide reasonable assurance of safety and effectiveness of OTC hearing aids without the involvement of a licensed person; therefore, while FDA agrees that licensed professionals provide valuable services, FDA will not be incorporating further requirements to include additional information about the benefit of licensed professionals in the labeling.
(Comment 41) FDA proposed that the outside package labeling include a statement that the device may not be useful for more significant hearing loss or complicated hearing needs. Some comments expressed concern that the warning used “significant hearing loss” without providing a definition of how to distinguish mild to moderate from significant hearing loss. These comments suggested that FDA further delineate mild to moderate from significant hearing loss, some of them suggesting we use objective criteria rather than more-subjective perceptual terms.
(Response) The final labeling requirements include the signs suggestive of both perceived mild to moderate hearing impairment and more significant hearing impairment. FDA included this information to assist consumers in determining whether OTC hearing aids can meet their needs. We have improved the phrasing of this information to be more understandable to inexperienced hearing aid users, including by removing the phrases the comments characterized as not defined well enough. However, as discussed in the response to Comment 24, FDA is declining to define hearing impairment in terms of objective criteria for the reasons explained in that response. We are continuing to delineate the different degrees of severity with perceptual terms as we believe this will be most useful to the intended users.
(Comment 42) Comments expressed concern that the symptoms suggesting perceived mild to moderate hearing impairment can also be indications of more significant hearing loss.
(Response) FDA infers these comments are concerned that consumers may mistake their degree of hearing loss due to the commonality of symptoms. FDA disagrees. FDA has specified some listening scenarios that represent some of the most common perceptual difficulties a user with perceived mild to moderate hearing impairment may experience. Although these symptoms may apply to multiple types and degrees of impairments, they are most common to perceived mild to moderate hearing impairment and therefore helpful to prospective users of OTC hearing aids. Further, FDA is also requiring that the symptoms commonly experienced by individuals with more significant impairment, with a recommendation to consult with a hearing healthcare professional, be included on the outside package labeling. Although FDA is finalizing more user-friendly language, we are declining to modify the symptoms for perceived mild to moderate hearing impairment. We believe that this information, along with the information required in the labeling to assist people with more severe impairment, will help prospective users determine whether an OTC hearing aid is a good choice for them.
(Comment 43) A few comments suggested labeling requirements include notice to individuals younger than 18 years old who are experiencing hearing issues that they should visit a hearing healthcare provider prior to using hearing aids due to complications that can cause auditory impairment and developmental issues.
(Response) FDA agrees with the concerns expressed by these comments and believes the labeling requirements address these concerns. For example, the labeling requirements in the proposed rule, which are being finalized here, include language that individuals under the age of 18 should consult with a doctor and refrain from using OTC hearing aids. It emphasizes the possible need for medical testing and the potential for hearing impairment in younger people to affect speech and learning.
(Comment 44) A few comments recommended that labeling include an explanation on the differences between prescription hearing aids, OTC hearing aids, and PSAPs to help consumers to select the appropriate device.
(Response) FDA is declining to require in the labeling an explanation of the differences between OTC hearing aids, prescription hearing aids, and PSAPs. Although this information may be helpful to know, it is not necessary for reasonable assurance of safety and effectiveness of OTC or prescription hearing aids. The labeling requirements for OTC hearing aids include common symptoms of those with mild to moderate hearing impairment and symptoms of more significant hearing loss to help consumers decide whether an OTC hearing aid is a good choice for them. Further, as discussed elsewhere in this document, prescription hearing aids must be sold only to or on the prescription or other order of a licensed practitioner (see § 801.109). Therefore, a licensed practitioner will be involved in determining whether a prescription hearing aid is appropriate for an individual with hearing impairment. Additionally, FDA is issuing a guidance with this final rule that will provide additional clarification of the differences between hearing aids and PSAPs. The notification of availability for the guidance appears elsewhere in this issue of the
Federal Register
.
(Comment 45) A few comments requested that OTC hearing aid labeling include a warning that people should not use OTC hearing aids if they have tinnitus. Comments expressed concern that tinnitus can be an indicator of serious medical conditions requiring proper management from a hearing healthcare professional, and failure to seek immediate treatment could cause further harm.
(Response) In the labeling requirements, FDA has included tinnitus in one ear as a condition for which users should seek medical evaluation. FDA is declining to expand upon this labeling requirement to include tinnitus in both ears since bilateral tinnitus often occurs in the presence of any degree of hearing loss. As such, the warning would be overly broad if it were to include bilateral tinnitus.
(Comment 46) A few comments suggested modifying the proposed language recommending users consult a hearing healthcare professional if they remain concerned about their hearing or struggle to use the device. The comments suggested that the labeling recommend users first contact the manufacturer to allow them an opportunity to resolve any issues.
(Response) FDA is declining to implement this suggestion. The statement notifies users that dissatisfaction with the compensation for impaired hearing may call for the attention of a hearing healthcare professional. Although FDA sees the potential benefit in users consulting with manufacturers to resolve certain technical or use questions, the purpose of the note is not to assist with device troubleshooting. Manufacturers may, however, include a troubleshooting section (or similar section) in the user instructions and provide suggestions for when users should consult them for technical or use issues that would not necessarily call for the involvement of a hearing healthcare professional.
(Comment 47) Some comments requested FDA require the labeling on and/or inside the package of OTC hearing aids include information about telecoils. Comments expressed concern that first-time hearing aid purchasers will not be able to make informed decisions about telecoils without an explanation of telecoil capabilities. Specific labeling suggestions varied, but they included statements of whether the device includes telecoils, explanations of what telecoils are, and the benefits telecoils may provide.
(Response) FDA is declining this suggestion because not all OTC hearing aids will have telecoils, and existing requirements would apply, for example for adequate directions for use (see section 502(f)(1) of the FD&C Act and § 801.5). (See also the response to Comment 94 about requiring telecoils.) Including the information about the feature could be confusing to consumers when the device does not include telecoils. Conversely, if a hearing aid includes telecoils, information about them would be necessary to provide adequate directions for use, so the information would have to appear in the labeling (see section 502(f)(1) of the FD&C Act and § 801.5).
(Comment 48) Some comments requested that labeling for OTC hearing aids include a questionnaire to assist consumers in deciding if OTC hearing aids are appropriate for them. Comments recommended the questionnaire to assist consumers in determining if they have a medical condition that requires a visit to a hearing health care provider prior to using OTC hearing aids.
(Response) FDA will not be implementing this suggestion. The labeling requirements we are finalizing, including information on Red Flag conditions and symptoms of more significant hearing loss, are sufficiently informative to provide reasonable assurance of safety and effectiveness without the additional time and effort necessary to complete a questionnaire and assess the results for purposes of deciding whether an OTC hearing aid is appropriate.
(Comment 49) A few comments expressed concern about the note regarding what a hearing aid can do, which includes a statement that, if a user has hearing loss in both ears, use of hearing aids for both ears (bilateral hearing aids) may provide more benefit than just one hearing aid. Comments suggested that this may discourage individuals who wish to begin with only one hearing aid. Comments recommended removing this paragraph from the note.
(Response) FDA disagrees that this statement would deter individuals from using one hearing aid. This statement does not suggest that individuals must use two hearing aids in all cases. This statement in the note simply conveys that two OTC hearing aids may provide more benefit in the case of hearing loss in both ears. Moreover, should individuals with hearing loss in both ears start with one OTC hearing aid and desire more benefit, this information would be useful to help them understand how to achieve greater benefit.
(Comment 50) A few comments requested that the labeling include guidance as to what to do when an eartip gets stuck in the ear canal.
(Response) FDA infers that the information requested by comments is meant to assist users in determining when to consult a healthcare professional. FDA agrees that providing guidance to users on this issue is important. We have updated the labeling to help users decide when to seek medical help (see new § 800.30(c)(2)(iii)(C)).
3. Outside Package Labeling and Purchasing Decisions
(Comment 51) A few comments recommended a statement for individuals with ability limitations, such as a developmental disability, similar to statements directing people under the age of 18 to seek examination and evaluation by hearing healthcare professionals. Commenters implied that, just as with individuals under 18, individuals with ability limitations may not have the same ability to determine their hearing loss or the presence of more serious medical issues; therefore, evaluation by a licensed professional would be necessary.
(Response) FDA is declining to implement this suggestion. The statements addressed to those under age 18 concern hearing healthcare needs that are specific to younger people, such as speech and learning difficulties. Additionally, as explained in the proposal, the use of OTC hearing aids in people younger than 18 presents risks to health beyond those typically associated with use in older people. Whereas hearing loss in older adults is most commonly related to noise exposure and aging, the etiology (causes) of hearing loss in younger people is varied and may result from conditions that warrant prompt diagnosis to avoid serious risks to health (see 86 FR 58150 at 58158). The comments provided no information to support that adults with ability limitations face similar risks to those younger than 18.
Further, we have revised the labeling with more user-friendly terms throughout. We believe the information required in the labeling, including statements identifying Red Flag conditions and advising users to consult with a hearing healthcare professional if they continue to struggle with or remain concerned about their hearing, are appropriate for adults with perceived mild-to-moderate hearing impairment. We do not agree that revising the labeling or limiting purchases for certain adults in the manner suggested by the comments is necessary to provide reasonable assurance of safety and effectiveness of OTC hearing aids.
(Comment 52) A comment requested that FDA standardize the names of hearing aid features so that interested people could compare products more easily. In that vein, multiple comments suggested that FDA develop a rating system to compare features. The commenter expressed that information should be accessible to lay users and that relying on a regulatory guidance document, should FDA issue one in the future, to convey such information is unlikely to assist most consumers, who are not experts in hearing aid technology. Similar comments desired a rating system for device performance in certain conditions, for example, live concerts.
(Response) FDA agrees that interested people should have sufficient information to compare products as easily as possible, and we have made various revisions in this final rule to
improve the usefulness of the required labeling for laypeople. We are also finalizing a requirement for a conspicuous mark identifying the hearing aid as OTC that we expect will help purchasers and others distinguish product categories (see Additional Revision 2 in section III.D.3). Further, FDA's website describes common hearing aid technologies and features to help orient consumers with the technology and terminology, available at:
https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids.
However, we are not making additional revisions in the final rule to standardize the names of device features.
We note that a number of regulatory requirements will nevertheless assist consumers to compare devices and features. For example, the applicable classification regulation for a device specifies the name of the device type (so is standardized in that way), and the principal display panel on the package of an OTC device must display a statement of identity that includes the common name of the device, in bold typeface (see § 801.61). Further, the labeling must include adequate directions for use that allow a layperson to use the device safely and for its intended purpose(s) (see § 801.5). And for OTC hearing aids, we proposed and are finalizing a requirement under new § 800.30(c)(4) that the labeling include certain technical specifications. Purchasers interested in the electroacoustic performance could use this information to compare across devices.
We acknowledge that manufacturers may use proprietary names for device features, even when other manufacturers offer a similar feature under a different name (perhaps also proprietary). However, FDA expects that hearing aid technology will continue to evolve and that device features will similarly evolve, including the specific capabilities. Precisely identifying, describing, and naming those features and ways to compare them by regulation, even for the present, is neither practical nor necessary. Further, individuals may have different preferences as to which features are more valuable in a hearing aid. For similar reasons, a rating system is neither practical nor necessary. Even with additional standardization of terminology, the import of each feature may still not be apparent to purchasers, and similarly, rating systems may not reflect (rate highly) the features of a device that a given purchaser would value. Thus, finalizing regulatory requirements for such a system of comparison is not likely to communicate useful information to purchasers and may hinder innovation by codifying current characteristics of device features.
To communicate useful information, we expect that manufacturers will describe their devices' features in ways that best appeal to the intended users, and the labeling of a hearing aid will have to be available to prospective users prior to purchase (see new §§ 800.30(c)(2) and 801.422(c)(2)). Moreover, the labeling of a device must not be false or misleading in any particular (see 21 U.S.C. 352(a)(1)). These requirements will help ensure that purchasers have accurate information about a hearing aid and its features in a way that allows them to compare these devices.
As for ratings for device performance in certain conditions, given the subjective nature of user preferences, developing a useful rating system is impracticable. We expect that purchasers will have access to a wealth of opinions from other purchasers, product testers or reviewers, and consumer information organizations. This will allow purchasers to find ratings that reflect their interests more than any possible criteria standardized by regulation. For example, a purchaser may prefer OTC hearing aids that users rate highly for use in a restaurant. Additionally, user preferences may change in the future, so any rating system may become quickly outdated.
Regarding device performance more generally, as we explained in the proposal, we are establishing electroacoustic performance requirements for high-fidelity amplification (see 86 FR 58150 at 58163). A hearing aid must meet these requirements to be available OTC, but the device need not outperform them. By extension, a device need not perform better than a high-fidelity level of amplification. Establishing a rating system for compliant devices, that is, for those that would already have high fidelity, would incorrectly imply some devices are substandard. We are not finalizing requirements for describing how well a device performs beyond the electroacoustic performance specifications in the labeling, the performance itself being required to meet a standard for high fidelity.
(Comment 53) A few comments recommended that information about whether a battery was included, and what type of battery is required, be included on the labeling. Comments recommended the inclusion of this information so that consumers can purchase the necessary batteries at the same time as the OTC hearing aid and adequately compare OTC hearing aids.
(Response) We agree that it is important for manufacturers to include information about the type, as well as the number, of batteries, and whether batteries are included because this is information consumers will need to use the hearing aid. Therefore, FDA is revising the final rule to require this information on the labeling outside the package of the hearing aid so that consumers are aware of the battery requirements prior to, or at the time of, purchase.
(Comment 54) A few comments recommended including a description of any smartphone compatibility requirements to operate the hearing aid on the outside package labeling. Comments argued this would allow consumers to determine if they have the necessary device and programming to operate the hearing aid prior to purchase.
(Response) FDA agrees with the comments that this information is important for consumers to know when comparing OTC hearing aids at the retailer. Similar to the battery information discussed above, information on the control platform is necessary for use of the hearing aid. Therefore, FDA is revising the final rule to require that the outside package labeling indicate whether a mobile device or other non-included control platform is required, such as a smartphone, a remote sold separately, or a personal computer. The labeling also will have to indicate the type of control platform and how the hearing aid connects to the control platform, for example, via Bluetooth and/or USB-C.
(Comment 55) A few comments suggested that the rule require a list of other basic features of each OTC hearing aid (for example, mobile operating system, volume controls, feedback, telecoil, or accessories) on the outside package. Comments expressed concern that, without a list of features, consumers may have difficulty comparing different OTC hearing aids and make an informed decision.
(Response) FDA is declining to implement this suggestion in its entirety. The packaging provides limited space for required labeling, and while we have adopted some such suggestions—see the responses to Comment 53, about batteries, and Comment 54, about smartphone compatibility—we have not determined that the other information is necessary on the outside package labeling to provide reasonable assurance of safety and effectiveness. Additionally, we are finalizing the requirements as proposed
that the inside package labeling, among other requirements, provide illustration(s) of the OTC hearing aid that indicates operating controls, user adjustments, and the battery compartment (see § 800.30(c)(2)(iv)), provide information on the function of all controls intended for user adjustment (see § 800.30(c)(2)(v)), and describe any accessory that accompanies the OTC hearing aid (see § 800.30(c)(2)(vi)). As the inside package labeling must be made available prior to purchase (see § 800.30(c)(2)), consumers will be able to access this information prior to purchase. Further, as discussed in the response to Comment 26, any OTC hearing aid must have labeling that bears adequate directions for use that allow a lay user to use the device safely and for its intended purposes (see § 801.5). In cases where necessary for adequate directions for use, information on other features not specified in § 800.30(c) will have to appear in the labeling, and prospective users will have access to the labeling prior to purchase.
(Comment 56) Some comments expressed concerns for device labeling that states an OTC hearing aid is “FDA approved,” “FDA cleared,” or otherwise endorsed by the FDA. The comments asserted that such labeling indicates that: FDA has inspected an OTC device for quality and/or compliance with applicable legal requirements, that FDA has approved the device for use by the individual purchaser, and/or that FDA favors the device over others without such labeling. The comments argued that such indications are misleading for purchasers.
(Response) FDA does not endorse particular devices and representations of such in labeling can be false or misleading. The determination of whether “FDA cleared,” “FDA approved,” or similar language on a device's labeling suggests FDA endorsement of the device or is otherwise false or misleading is made on a case-by-case basis.
Clearance of a device indicates that FDA has determined the device to be substantially equivalent to a class I or II device. It does not in any way denote official approval of a device or in any way imply that the device is in compliance with any other pertinent sections of the FD&C Act (see 41 FR 37458 at 37462, September 3, 1976). Likewise, a grant of a De Novo classification request under 21 CFR 860.260(a)(1) or compliance with registration and listing requirements under part 807 does not denote official approval or imply compliance with other pertinent device requirements. Any representation that creates an impression of official approval of a device due to complying with requirements for premarket notification or registration is misleading and constitutes misbranding (see §§ 807.97 and 807.39, respectively).
The labeling of a device may be false or misleading for other reasons too. For example, if a statement in the labeling creates an impression that FDA officially favors one classified device over another, it would likely be false or misleading. Or, if the labeling uses FDA's logo, creating an impression that FDA has endorsed the product, it would likely be false or misleading.
8
A device would be deemed to be misbranded under section 502(a)(1) of the FD&C Act if its labeling included such false or misleading statements. The FD&C Act prohibits doing or causing certain acts with respect to a misbranded device (see,
e.g.,
21 U.S.C. 331(a)-(c), (k)).
8
FDA's logo is not for use on private sector materials, including device packaging. For more information, you may wish to review FDA's logo policy, available at:
https://www.fda.gov/about-fda/website-policies/fda-logo-policy.
(Comment 57) A comment requested clarification on the applicability of prescription labeling requirements under new § 801.422 to the implantable components of a bone-conduction hearing aid. The comment argued that applying the labeling requirements to the implantable components is unnecessary because a surgeon has already decided to implant specific components, and the labeling under new § 801.422 is neither necessary nor helpful for the surgeon or the hearing aid user. In contrast, the non-implantable components of a bone-conduction hearing aid, such as the sound processor, are often marketed separately and not necessarily through a physician.
(Response) FDA agrees that the labeling requirements under § 801.422 are not necessary for reasonable assurance of safety and effectiveness with respect to the implantable components of a bone-conduction hearing aid. We have modified the classification regulation to clarify that the labeling requirements for prescription hearing aids apply only to the non-implantable components of a bone-conduction hearing aid. In cases where the implantable components are not sold or distributed with the non-implantable components, the implantable components need not bear the labeling under new § 801.422.
(Comment 58) One comment requested that FDA strike § 801.422(c)(1)(ii)(A). The comment stated that the decision to offer trial rentals or purchase options is a trade issue and does not relate to the safety or effectiveness of the device.
(Response) FDA has decided to retain § 801.422(c)(1)(ii)(A) (in the final rule, this information is in § 801.422(c)(1)(i)(C)). FDA notes that § 801.422(c)(1)(ii)(A) does not require offering a trial-rental or purchase-option program. Instead, this provision just requires that the outside package labeling for a prescription hearing aid include information advising prospective users to inquire about the availability of a trial-rental or purchase-option program.
FDA also notes that § 801.422(c)(1)(ii)(A) is substantially identical to what was already required to be included in the user instructional brochure for a hearing aid under former § 801.420(c)(3). In other words, the information required under § 801.422(c)(1)(ii)(A) is not new and has been required to be in hearing aid labeling for many years. The only differences between §§ 801.420(c)(3) and 801.422(c)(1)(ii)(A) are: § 801.422(c)(1)(ii)(A) applies only to prescription hearing aids, § 801.422(c)(1)(ii)(A) requires that the information be provided on the outside package labeling for a prescription hearing aid, and the required statement under § 801.422(c)(1)(ii)(A) uses language that is easier to understand.
FDA continues to believe that this labeling requirement is necessary to provide reasonable assurance of safety and effectiveness of prescription hearing aids. When FDA included the requirement in former § 801.420(c)(3) to provide information in the user instructional brochure advising prospective users to inquire about the availability of a trial-rental or purchase-option program, FDA acknowledged the difficulty of determining in advance whether an individual will benefit from a hearing aid, and we noted that voluntary trial-rental or purchase-option programs for prospective hearing aid users were available (42 FR 9286 at 9289).
FDA believed that trial-rental or purchase-option programs, which provide prospective hearing aid users the opportunity to wear the selected hearing aid so that the user can make an informed judgment on whether a benefit is obtained from the use of the hearing aid, were important to the welfare of the hearing impaired and therefore, required that the user instructional brochure contain information advising prospective users to inquire about the availability of such program (42 FR 9286 at 9289). FDA explained that this information would help assure that the
selected hearing aid would be beneficial and would encourage hearing aid use among those prospective users who lack the motivation to try a hearing aid because of the fear that they will spend a great deal of money with no guarantee of benefit (42 FR 9286 at 9289). FDA believes that the reasons for requiring this information in labeling continue to apply for prescription hearing aids, which are typically sold through licensed hearing aid dispensers, many of whom offer such programs.
(Additional Revision 2) In response to various concerns evident in the comments, we are including in this final rule a requirement that the principal display panel of the outside package labeling of an OTC hearing aid bear the conspicuous marks, “OTC” and “hearing aid.” FDA intends these marks to clarify for purchasers and others, including retailers and State agencies, whether a product is a hearing aid (regulated as a device), and whether it is available OTC. (See also the response to Comment 18 discussing hearing aid terminology.) However, these marks do not in any way denote official approval of the device, and any representation that creates an impression of official approval because of complying with these marking requirements or with the OTC Hearing Aid Controls would be considered false or misleading and constitute misbranding. (See also the response to Comment 56 regarding other false or misleading statements.) The marking is necessary for reasonable assurance of safety and effectiveness of OTC hearing aids because it provides assurances that non-OTC hearing aids or non-devices will not be confused for OTC hearing aids.
The marks must have the same prominence as required under § 801.61(c) for the device's statement of identity, and a manufacturer may satisfy this new marking requirement if the statement of the device's common name includes both “OTC” and “hearing aid.” For example, a manufacturer may label its product as a “Self-Fitting OTC Hearing Aid” (assuming the device's common name is “self-fitting hearing aid”). Such a device would meet this new marking requirement as well as the requirement for the common name in the statement of identity. Alternatively, the manufacturer may, for example, label its product without including the marks in the common name of the device, perhaps by placing “OTC” in a corner of the principal display panel with the required prominence (assuming the device's common name includes “hearing aid”). Formatting the marks, for example, by outlining them with a box, would be permissible provided the formatting does not cause the marks to lack the required prominence (see 21 CFR 801.15(a)(6)).
4. Labeling Inside the Package and Technical Matters
(Comment 59) A few comments requested that the frequency response and ANSI S3.22 specifications of OTC hearing aids be included in the user manual.
(Response) FDA infers this request is to assist in selecting an OTC hearing aid with optimal performance. We are not requiring the requested information in OTC hearing aid labeling because, as we explained in the proposal, this information is highly technical and generally not useful to the lay user (see 86 FR 58150 at 58163). However, we are finalizing the proposed requirement that OTC hearing aid labeling include key electroacoustic performance specifications that are more likely to assist prospective lay users in comparing and selecting the devices, including the values for maximum output, full-on gain, total harmonic distortion, self-generated noise, latency, and upper and lower cutoff frequencies for the acoustic bandwidth.
(Comment 60) A few comments expressed concern that requiring summaries of clinical studies conducted by or for the manufacturer on the inside labeling is not practical. Comments suggested that providing a link to an online library of the clinical studies and a summary of each study on the manufacturer's website would suffice.
(Response) FDA disagrees that providing summaries of clinical studies in the labeling inside the package is impractical. While we understand that fully appreciating the outcomes of a study can entail a lengthy technical document, presenting the most important findings regarding the performance of the OTC hearing aid, in a user-friendly format, need not take significant space in the labeling. We are finalizing the requirement as proposed.
(Comment 61) A few comments requested that the labeling include information on how the OTC hearing aid can be fixed or repaired. Comments requested that the information include whether a local hearing healthcare professional can repair the device or if it needs to be sent to the manufacturer. Comments argued this would allow prospective users to make an informed decision when purchasing their devices.
(Response) FDA agrees that manufacturers should provide users with information on how to have their hearing aid repaired because this information may be difficult for users to obtain on their own. The inside package labeling requirements now include information on how and where to obtain repair service or replacements, with at least one specific address where the user can go or send the OTC hearing aid to obtain such repair service or replacements.
(Comment 62) A few comments expressed concern that estimating the expected battery life will be difficult for manufacturers due to inconsistencies between batteries and use conditions. Comments proposed removing this requirement from the labeling inside the package.
(Response) FDA recognizes that battery performance can vary but will retain this requirement in the final rule because this information will help prospective purchasers determine whether a hearing aid will be suitable for their circumstances. Recognizing that performance can vary from device to device, we did not propose, and are not requiring, a specific method of estimating the battery life. However, manufacturers may want to review Clause 4.7 (Battery Life) of ANSI/CTA-2051:2017, which currently provides an acceptable method to estimate the battery life (Ref. 8).
(Comment 63) A comment proposed a requirement for OTC hearing aid labeling to include information about the transport methods for configuration information and other data to and from the OTC hearing aid with all points along the supply chain.
(Response) FDA is not adopting this proposal because such information is focused on the electronic transfer of non-diagnostic data and is not generally necessary for reasonable assurance of safety and effectiveness of all OTC hearing aids. We note, however, that should States establish or continue in effect requirements to disclose such information, and the requirements are not specifically applicable to hearing products, section 709(b)(4) of FDARA likely would not preempt them. However, FDA is not opining on whether such disclosure requirements likely would or would not be preempted under section 521(a) of the FD&C Act. (See also the response to Comment 115 concerning the collection of personal information as part of a sale of an OTC hearing aid.)
(Comment 64) A comment requested that FDA require labeling that specifies the latency of any wireless streaming technologies the OTC hearing aid uses.
(Response) In certain circumstances, latency information in the labeling may be necessary under existing requirements. For example, if the information is necessary to provide adequate directions for use or necessary
for practitioners licensed by law to use the device safely and for its intended purpose(s), then the latency information would have to appear in the device labeling (see §§ 801.5 and 801.109(c), respectively).
However, as a general matter for hearing aids that incorporate wireless streaming technology, FDA has determined that stating the streaming latency is not necessary to provide reasonable assurance of safety and effectiveness. Additionally, a variety of factors can affect wireless streaming latency, including nearby radio interference, distance between the transmitter and receiver, and the presence of materials that absorb certain radiofrequencies. As such, a standardized wireless streaming latency value may not reflect a particular device's design or the environment in which the user wears the hearing aid; and thus, FDA is not adding a requirement to include wireless streaming latency information for all OTC hearing aids in this rule. We note that FDA is finalizing requirements for OTC hearing aid labeling to include manufacturer contact information. If users or prospective users are interested in the streaming latency specifically, they will be able to contact the manufacturer.
(Comment 65) A few comments requested a labeling requirement describing the fitting range across different frequencies (500, 1000, 2000, and 4000 Hertz) to help consumers determine the suitability of different OTC hearing aids to meet their needs.
(Response) FDA understands that traditionally, hearing aids are designed and marketed with a specific fitting range in mind, and manufacturers may maintain this practice. However, OTC hearing aids are intended to be available without the involvement of a licensed person (see 21 U.S.C. 360j(q)(1)(A)(v)). As such, FDA is not using audiometry-defined thresholds or ranges of hearing loss in the final rule. Instead, FDA is using descriptions of common symptoms of mild to moderate hearing impairment in the labeling. As such, describing the fitting ranges across different frequency bands is not necessary for reasonable assurance of safety and effectiveness of OTC hearing aids. However, manufacturers may choose to include this information in device labeling, and prospective users will have access to the manufacturer's contact information prior to purchase should they desire to inquire about the fitting ranges.
5. Adverse Event Reporting
(Comment 66) The proposed labeling included instructions on reporting adverse events through the MedWatch portal,
https://www.fda.gov/Safety/Medwatch,
or by phone, 1-800-FDA-1088. A few comments requested that email and mailing options also be provided for adverse event reporting. Comments further recommended that FDA provide a receipt of the complaint to individuals.
(Response) We are declining to include a mailing address in the labeling because submissions by mail should be on a MedWatch form, for example, the Consumer Voluntary Reporting Form (FDA 3500B), which contains the address along with additional instructions. Reference to just the address in hearing aid labeling may result in reports submitted in an unexpected manner and format, potentially causing confusion, incomplete reports, and significant delays in processing them. However, in addition to reporting events through the MedWatch portal and 1-800-FDA-1088, consumers can submit their adverse event reporting form to FDA by fax or the mailing address according to the instructions on the form. Submitters will receive a reply from FDA after we receive their report. Email is not currently an alternative to the MedWatch online submission system.
(Comment 67) A few comments recommended that in addition to labeling information on reporting adverse events to FDA, contact information for manufacturers should be required so that manufacturers are provided the opportunity to review adverse events. Comments implied that providing manufacturers with awareness about adverse events and opportunity to address them would be beneficial to consumers.
(Response) To help facilitate communications between users and manufacturers, FDA has added the manufacturer's email and mailing address to the labeling requirements (see final § 800.30(c)(1)(i)(E)). Should users wish to report adverse events to the manufacturer, they may use this information to do so. Manufacturers may also include instructions in the labeling, that do not conflict with the labeling requirements, on how to directly report adverse events to them.
(Comment 68) FDA included in the proposed labeling examples of adverse events to be reported to FDA: irritation of the ear canal or outer ear skin, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting lodged in the ear canal, and sudden increased severity in hearing loss with the device. Some commenters suggested limiting the list to more-serious conditions to avoid the adverse reporting system being overwhelmed by reports of minor adverse events. Commenters expressed concern that if the labeling were finalized as proposed, more serious adverse events may get lost in the volume of what the commenters see as minor. Commenters recommended adverse event reporting be limited to significant injury and/or death.
(Response) FDA is declining to limit the examples of adverse events, or the reporting of adverse events, to significant injury and/or death. FDA is interested in receiving information on all adverse events to have a better understanding of OTC hearing aid product safety and performance. Additionally, under section 709(d) of FDARA, FDA is required to submit a report to Congress “analyzing any adverse events related to over-the-counter hearing aids.” FDA is prepared to review adverse event reports and has experience in sorting through adverse event reporting data to identify safety signals and trends.
(Comment 69) Comments requested that users of prescription hearing aids be able to report adverse events to FDA similar to how OTC hearing aid users can report through the MedWatch portal at
https://www.fda.gov/Safety/Medwatch,
or by phone, 1-800-FDA-1088.
(Response) We agree that prescription hearing aid users should also report adverse events to FDA. We proposed and are finalizing the same note for prescription hearing aids to notify users of how to report adverse events to FDA.
6. Miscellaneous Labeling Considerations
(Comment 70) Some comments recommended that restrictions on the use of OTC hearing aids by individuals under the age of 18 be removed. Comments expressed the need for cost effective hearing aids for individuals under 18. Additionally, comments asserted that individuals under 18 are increasingly suffering from hearing loss as a result of exposure to loud sounds, which they argued is hearing loss that can be addressed by OTC hearing aids.
(Response) FDA is declining to allow the sale of OTC hearing aids to individuals under the age of 18. This condition for sale is consistent with section 709(b)(2)(C) of FDARA and section 520(q)(1)(A)(ii) of the FD&C Act, which establish that OTC hearing aids are only intended for people aged 18 and older. The use of OTC hearing aids
in people younger than 18 presents risks to health beyond those typically associated with use in older people. While FDA appreciates th
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