Medical Devices; Hearing Aids; Technical Data Amendments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 99N-2550]

Medical Devices; Hearing Aids; Technical Data Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its regulations governing hearing aid labeling to reference the most

recent version of the consensus standard used to determine the

technical data to be included in labeling for hearing aids. FDA is

proposing to amend the regulation in order that manufacturers may use

state-of-the-art methods to address technical data in hearing aid

labeling. This proposed rule is a companion document to the direct

final rule published elsewhere in this issue of the Federal Register.

DATES: Submit written comments on or before January 18, 2000. If FDA

receives any significant adverse comment regarding this rule, FDA will

publish a document withdrawing the direct final rule within 30 days

after the comment period ends. FDA then and will proceed to respond to

the comments under this proposed rule using the usual notice and

comment procedures. Any parties interested in commenting on this

document should do so at this time.

If FDA receives no significant adverse comments within the

specified comment period, the agency intends to publish a document

confirming the effective date of the final rule in the Federal Register

within 30 days after the comment period on the direct final rule ends.

The direct final rule will be effective March 17, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David A. Segerson, Center for Devices

and Radiological Health (HFZ-460), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850 301-594-2080.

SUPPLEMENTARY INFORMATION:

I. Regulatory Framework

This proposed rule is a companion to the direct final rule

published in the final rules section of this issue of the Federal

Register. This companion proposed rule is substantively identical to

the direct final rule. This proposed rule will provide a procedural

framework to finalize the rule in the event the agency receives a

significant adverse comment and the direct final rule is withdrawn. FDA

is publishing the direct final rule because the rule contains

noncontroversial changes, and FDA anticipates that it will receive no

significant adverse comments. A detailed discussion of this rule is set

forth in the preamble of the direct final rule. If no significant

comment is received in response to the direct final rule, no further

action will be taken related to this proposed rule. Instead, FDA will

publish a confirmation document within 30 days after the comment period

ends confirming that the direct final rule will go into effect on March

17, 2000. Additional information about FDA's direct final rulemaking

procedures is set forth in a guidance published in the Federal Register

of November 21, 1997 (62 FR 62466).

If FDA receives a significant adverse comment regarding this rule,

the agency will publish a document withdrawing the direct final rule

within 30 days after the comment period ends and will proceed to

respond to the comments under this rule using usual notice-and-comment

procedures. The comment period for this companion proposed rule runs

concurrently with the direct final rule's comment period. Any comments

received under this companion proposed rule will also be considered as

comments regarding the direct final rule. A significant adverse comment

is defined as a comment that explains why the rule would be

inappropriate, including challenges to the rule's underlying premise or

approach, or would be ineffective or unacceptable without a change. In

determining whether a significant adverse comment is sufficient to

terminate a direct final rulemaking, FDA will consider whether the

comment raises an issue serious enough to warrant a substantive

response in a notice-and-comment process. Comments that are frivolous,

insubstantial, or outside the scope of the rule will not be considered

adverse under this procedure. For example, a comment requesting a

change in provisions of the hearing aid rule unrelated to the subject

matter addressed in the American National Standards Institute's (ANSI)

standard will not be considered a significant adverse comment, because

it is outside the scope of the rule. On the other hand, a comment

recommending an additional change to the rule may be considered a

significant adverse comment if the comment demonstrates why the rule

would be ineffective without the additional change. In addition, if a

significant adverse comment applies to an amendment, paragraph, or

section of this rule and that provision can be severed from the

remainder of the rule, FDA may adopt as final those provisions of the

rule that are not the subject of a significant adverse comment.

II. Background

In the Federal Register of February 15, 1977 (42 FR 9286), FDA

published final regulations establishing requirements for professional

and patient labeling of hearing aids (Sec. 801.420 (21 CFR 801.420))

and governing conditions for sale of hearing aids (Sec. 801.421 (21 CFR

801.421)). The regulations became effective on August 15, 1977. Section

801.421(b)(1) of the regulations provides that, before the sale of a

hearing aid to a prospective user, a hearing aid dispenser is to

provide the prospective user with a copy of the User Instructional

Brochure. Section 801.420(c)(4) requires that technical data useful in

selecting, fitting, and checking the performance of a hearing aid be

provided in the brochure or in separate labeling that accompanies the

device. The regulation further required that the technical data values

provided in the brochure or other labeling be determined according to

the test procedures established by the Acoustical Society of America

(ASA) in the ``American National Standard

[[Page 59696]]

Specification of Hearing Aid Characteristics,'' ANSI S3.22-1976 (ASA

70-1976), which was incorporated by reference in the regulation.

ANSI S3.22 (ASA 70-1976) established measurement methods and

specifications for several definitive hearing aid characteristics, and

provided a method of ascertaining whether a hearing aid, after being

manufactured and shipped, met the specifications and design parameters

stated by the manufacturer for a particular model, within the tolerance

stated by the standard.

In 1982, ASA revised the standard (ANSI S3.22-1982) (ASA 70-1982).

In a final rule published in the Federal Register of July 24, 1985 (50

FR 30153), FDA incorporated the revised standard into

Sec. 801.420(c)(4). ASA revised the standard again in 1987 (ANSI S3.22-

1987) (ASA 70-1987). In a final rule published in the Federal Register

of December 21, 1989 (54 FR 52395). FDA incorporated the newly revised

standard into Sec. 801.420(c)(4).

In 1996, ASA revised the standard again (ANSI S3.22-1996) (ASA 70-

1996). The standard describes air-conduction hearing aid measurement

methods that are particularly suitable for specification and tolerance

purposes. Among the test methods described are output sound pressure

level (SPL with a 90-dB input SPL, full-on gain, frequency response,

harmonic distortion, equivalent input noise, current drain, induction-

coil sensitivity, and static and dynamic characteristics of automatic

gain control hearing aids) the standard gives specific configurations

for measuring the input SPL to a hearing aid. The standard also

describes allowable tolerances in relation to values specified by the

manufacturer for certain parameters. Appendices are provided to

describe an equivalent substitution method, characteristics of battery

simulators, and additional tests to characterize the electroacoustic

performance of hearing aids more completely.

FDA is now incorporating the 1996 standard into Sec. 801.420(c)(4).

This will allow hearing aid manufacturers to use the up-to-date methods

to determine the technical data values for hearing aids. In addition,

FDA is removing from Sec. 801.420(c)(4) the address for ``American

National Standards Institute'' and is adding in its place the address

for ``Acoustical Society of America.''

III. Environmental Impact

The agency has determined under 21 CFR 25.30(k) that this action is

of a type that does not individually or cumulatively have a significant

effect on the human environment. Therefore, neither an environmental

assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

FDA has examined the impact of the proposed rule under Executive

Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) (as

amended by subtitle D of the Small Business Regulatory Fairness Act of

1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of

1995 (Public Law 104-4). Executive Order 12866 directs agencies to

assess all costs and benefits of available regulatory alternatives and,

when regulation is necessary, to select regulatory approaches that

maximize net benefits (including potential economic, environmental,

public health and safety, and other advantages; distributive impacts;

and equity). The agency believes that this proposed rule is consistent

with the regulatory philosophy and principles identified in the

Executive Order. In addition, this proposed rule is not a significant

regulatory action as defined by the Executive Order and so is not

subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The proposed rule amends the existing hearing aid

regulation to refer to the updated consensus standard that is used to

determine the technical data in hearing aid labeling. Communications

from manufacturers to FDA show that they are prepared to be in

compliance with this standard immediately. The agency, therefore,

certifies that this proposed rule, if finalized, will not have a

significant economic impact on a substantial number of small entities.

This proposed rule also does not trigger the requirement for a written

statement under section 202(a) of the Unfunded Mandates Reform Act

because it does not impose a mandate that results in an expenditure of

$100 million or more by State, local, or tribal governments in the

aggregate, or by the private sector, in any one year.

V. Paperwork Reduction Act of 1995

FDA tentatively concludes that this proposed rule contains no

collection of information. Therefore, clearance by the Office of

Management and Budget under the Paperwork Reduction Act of 1995 is not

required.

VI. Request for Comments

Interested persons may, on or before January 18, 2000, submit to

the Dockets Management Branch (address above) written comments

regarding this companion proposed rule. The comment period runs

concurrently with the comment period for the direct final rule. Two

copies of any comments are to be submitted, except that individuals may

submit one copy. Comments are to be identified with the docket number

found in the brackets in the heading of this document. Comments will be

considered to determine whether to amend or revoke this proposed rule.

Received comments may be seen in the office above between 9 a.m. and 4

p.m., Monday through Friday. All comments received will be considered

as comments regarding the direct final rule and this proposed rule. In

the event the direct final rule is withdrawn, all comments received

regarding the direct final rule and this companion proposed rule will

be considered comments on this proposed rule.

List of Subjects in 21 CFR Part 801

Hearing aids, Incorporation by reference, Medical devices,

Professional and patient labeling.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 801 be amended as follows:

PART 801--LABELING

1. The authority citation for 21 CFR part 801 continues to read as

follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

2. Section 801.420 is amended by revising the second and third

sentences in paragraph (c)(4) to read as follows:

Sec. 801.420 Hearing aid devices; professional and patient labeling.

* * * * *

(c) * * *

(4) * * * The determination of technical data values for the

hearing aid labeling shall be conducted in accordance with the test

procedures of the American National Standard ``Specification of Hearing

Aid Characteristics,'' ANSI S3.22-1996 (ASA 70-1996) (Revision of ANSI

S3.22-1987), which is incorporated by reference in accordance with 5

U.S.C. 552(a) and 1 CFR part 51. Copies are available from the

Standards Secretariat of the Acoustical Society of America, 120 Wall

St., New York, NY 10005-3993, or are available for inspection at the

Regulations Staff, CDRH (HFZ-215), FDA, 1350 Piccard Dr., rm. 240,

[[Page 59697]]

Rockville, MD 20580, and the Office of the Federal Register, 800 North

Capitol St. NW. suite 700, Washington DC. * * *

* * * * *

Dated: October 19, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 99-28210 Filed 11-2-99; 8:45 am]

BILLING CODE 4160-01-F