[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Rules and Regulations]
[Pages 59618-59620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28209]



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.


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.


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 
    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:


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

    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]