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: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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. This amendment is being

made in order that manufacturers may use state-of-the-art methods to

address technical data in hearing aid labeling. FDA is amending

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the regulations in accordance with its direct final rule procedures.

Elsewhere in this issue of the Federal Register, FDA is publishing a

companion proposed rule under FDA's usual procedures for notice and

comment to provide a procedural framework to finalize the rule in the

event the agency receives a significant adverse comment and withdraws

this direct final rule.

DATES: This regulation is effective March 17, 2000. Submit written

comments on or before January 17, 2000. 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 this direct final rule ends. If timely significant adverse

comments are received, the agency will publish a document in the

Federal Register withdrawing this direct final rule before its

effective date. The Director of the Office of the Federal Register

approves the incorporation by reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51 of certain publications in Sec. 801.420(c)(4)

(21 CFR 801.420(c)(4)), 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. 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) 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 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 Standard Institute'' and is adding in its place the address

for ``Acoustical Society of America.''

II. Rulemaking Action

In the Federal Register of November 21, 1997 (62 FR 62466), FDA

described when and how FDA will employ direct final rulemaking. FDA

believes that this rule is appropriate for direct final rulemaking

because FDA views this rule as a noncontroversial amendment and

anticipates no significant adverse comments. Consistent with FDA's

procedures on direct final rulemaking, FDA is publishing elsewhere in

this issue of the Federal Register a companion proposed rule to amend

part 801 (21 CFR part 801). The companion proposed rule and the direct

final rule are substantively identical. The companion proposed rule

provides a procedural framework within which the rule may be finalized

in the event the direct final rule is withdrawn because of a

significant adverse comment. The comment period for the direct final

rule runs concurrently with the companion proposed rule. Any comments

to the companion proposed rule will be considered as comments regarding

the direct final rule.

FDA is providing a comment period on the direct final rule until

January 17, 2000. If the agency receives a significant adverse comment,

FDA intends to withdraw this final rule by publication in the Federal

Register within 30 days after the comment period ends. 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

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 significant or 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 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

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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.

If FDA withdraws the direct final rule, all comments received will

be considered under the proposed rule in developing a final rule in

accordance with usual Administrative Procedure Act notice-and-comment

procedures.

If FDA receives no significant adverse comment during the specified

comment period, FDA intends to publish a confirmation document within

30 days after the comment period ends confirming the effective date.

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 this direct final rule under

Executive Order 12866 and 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 direct

final rule is consistent with the regulatory philosophy and principles

identified in the Executive Order. In addition, this direct final 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 direct final 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 final rule will not have a significant economic

impact on a substantial number of small entities. This direct final

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

This direct final rule contains no collection of information.

Therefore clearance by the Office of Management and Budget under the

Paperwork Reduction Act of 1995 is no required.

VI. Request for Comments

Interested persons may, on or before January 17, 2000, submit to

the Docket Management Branch (address above) written comments regarding

this direct final rule. The comment period runs concurrently with the

comment period for the companion proposed 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

brackets in the heading of this document. 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

companion proposed rule and this direct final rule. In the event the

direct final rule is withdrawn, all comments received regarding the

companion proposed rule and this direct final rule will be considered

comments on the 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, 21 CFR part

801 is amended as follows:

PART 801--LABELING

1. The authority section 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,

Rockville, MD 20850, and at 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. 99-28209 Filed 11-2-99; 8:45 am]

BILLING CODE 4160-01-F