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August 15, 2008

Division of Dockets Management (HFA-305)

U.S. Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

**VIA ELECTRONIC SUBMISSION**

Re: [Docket No. FDA-2008-N-0148]{.underline}

> [Medical Devices; Hearing Aids; Technical Data Amendments]{.underline}

Dear Sir or Madam:

The Hearing Industries Association (HIA) appreciates the opportunity to
submit comments to the above-referenced proposed and direct final rule,
which the U.S. Food and Drug Administration (FDA) published in the
Federal Register on June 2, 2008. 73 Fed. Reg. 31,390 (June 2, 2008)
(proposed rule); 73 Fed. Reg. 31,358 (June 2, 2008) (direct final rule)
(collectively, the "Proposed Rule"). HIA is a trade association that
represents the interests of hearing health device manufacturers and
their suppliers. Collectively, our members produce the great majority of
the hearing aids sold in the United States.

In the Proposed Rule, FDA would revise the hearing aid regulations
(codified at 21 C.F.R. § 801.420) to reference a more recent version of
the consensus standard adopted by the Acoustical Society of America
(ASA). The consensus standard is used to determine the technical data
that FDA requires to be included in hearing aid labeling.

As discussed below, HIA reads the Proposed Rule to apply prospectively.
Furthermore, we have received an e‑mail from the Office of Compliance in
the Center for Devices and Radiological Health (Office of Compliance)
that we believe represents their agreement that the Proposed Rule is
intended to apply prospectively (a copy of the email is enclosed). If
our understanding is correct, then we support the Proposed Rule.
Otherwise, if FDA intends the Proposed Rule to apply retroactively to
require repeat testing on existing hearing aid models (despite the
seemingly prospective language of the Proposed Rule and the e‑mail
advice from the Office of Compliance), then we believe it imposes
excessive and unnecessary costs that will not provide a significant
benefit to consumers. In that case, we do not support the Proposed Rule
and believe FDA should revise it to apply only prospectively.

**I. [Factual Background]{.underline}**

The current regulation provides:

> "Technical data useful in selecting, fitting, and checking the
> performance of a hearing aid shall be provided in the User
> Instructional Brochure or in separate labeling that accompanies the
> device. The determination of technical 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 C.F.R. part 51." \[21 C.F.R. § 801.420(c)(4).\]

FDA proposes to update this provision to incorporate the most recent
ANSI standard. Specifically, the regulation would now reference the ANSI
S3.22‑2003, which revised the earlier ANSI S3.22‑1996 standard that is
currently referenced in the regulation. 73 Fed. Reg. at 31,360. FDA's
proposal is similar to previous amendments of this regulation to
incorporate periodically updated ANSI standards. *See* 64 Fed. Reg.
59,618, Nov. 3, 1999 (substituting 1996 revision of 1987 ANSI standard);
54 Fed Reg. 52,395 (Dec. 21, 1989) (substituting 1987 revisions of 1982
ANSI standard).

FDA proposes an effective date of October 15, 2008. FDA is proposing to
incorporate the ANSI testing standard issued in 2003 (with an April 2007
Erratum). The rule would become effective on October 15, 2008. FDA
states: "Communications from manufacturers to FDA show that they are
prepared to comply with this standard immediately." 73 Fed. Reg. at
31,359. This sentence appeared verbatim in the 1999 final rule updating
the regulation to incorporate the 1996 ANSI standard. 64 Fed. Reg. at
59,620. However, we are not aware of such communications from our
membership during the current rulemaking.

**II. [Comment]{.underline}**

During the design phase of a new hearing aid model, it undergoes testing
under the applicable ANSI standard required by 21 C.F.R.
§ 801.420(c)(4). This process may be referred to as "characterization"
of the hearing aid model. Once the data from characterization testing
are obtained, they are incorporated in the labeling and remain there
unchanged throughout the life of that model. The characterization
testing is expensive and time‑consuming and is typically a one‑time
event for each hearing aid model. In addition, however, each hearing
*device* within a particular hearing aid model may be calibrated and
tested prior to shipment to the customer (whether as a new device or
after repair). This testing would be intended to show compliance of the
individual device to the standard in effect when the model was
characterized. This latter type of testing may be called "production
testing."[^1]

The Proposed Rule provides: "The determination of technical 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 S3.22‑2003 (Revision of ANSI S3.22‑1996)
(Includes April 2007 Erratum)." 73 Fed. Reg. at 31,360.

We read this language as a prospective mandate applicable to
characterization testing, *i.e.*, when characterization testing is
conducted after the effective date of the Proposed Rule, the 2003
consensus standard "shall be" used. Nothing in this language purports to
retrospectively invalidate the technical values derived from
characterization testing under the 1996 standard prior to the effective
date of the Proposed Rule. Indeed, the reference to "*the* determination
of technical values" appears to reflect an understanding that such
characterization testing typically is a one‑time event for each hearing
aid model.

Thus, we understand this language to mean that characterization testing
conducted after the effective date of the Proposed Rule must comply with
the 2003 ANSI standard, but testing completed prior to the effective
date under the 1996 ANSI standard remains valid for inclusion in hearing
aid labeling.[^2] The Office of Compliance has advised in an e‑mail that
it understands the Proposed Rule to apply prospectively.[^3] If our
understanding is accurate (as confirmed by the Office of Compliance),
then we support the Proposed Rule and do not have an adverse comment.

On the other hand, if FDA intends that under the Proposed Rule all
existing hearing aid models must be retested and relabeled, then we
believe the Proposed Rule is unduly burdensome and costly. A survey of
our membership indicates that the such retesting would involve dozens of
models and, conservatively, would cost the industry millions of dollars.

We believe that the substantial cost of repeating characterization
testing for existing models is not justified by a significant benefit to
consumers. It is true that the updated ANSI standard is better focused
on testing modern digital aids rather than the older analog hearing
aids. Nonetheless, the updating of ANSI standards does not provide a
significant improvement in the ability of hearing aid dispensers to fit
their customers with appropriate aids among existing models. They have
done so successfully until now using characterization testing values
obtained under the 1996 consensus standard, and they can continue to do
so as the older models are phased out. We strongly believe that scarce
industry dollars would be better spent developing new and improved
hearing aid models rather than repeating characterization testing for
old models.

In closing, we request that FDA clarify in the final rule that it is
intended to apply only to characterization testing performed after the
effective date (and that production testing may continue to be congruent
with the standuard under which the characterization testing was
performed). On this basis, HIA supports the Proposed Rule. Conversely,
if the new rule would require recharacterization of each of the existing
models now being sold by HIA members with new testing, then HIA does not
support adoption of the Proposed Rule.

Thank you for your consideration of our comments.

Sincerely,

> Carole M. Rogin\
> HIA Executive Director

Enclosure -- E-mail to Office of Compliance (Aug. 1, 2008) and Response
Thereto (Aug. 7, 2008)

1444 I STREET, NW          SUITE 700          WASHINGTON, DC 20005\
PHONE: (202) 712-9033          FAX: (202) 216-9646         
www.hearing.org

[^1]: Any production testing must be congruent with the characterization
    testing and involve the same ANSI standard.

[^2]: Production testing performed after the effective date would have
    to be congruent with the original characterization testing, and we
    understand it would be similarly grandfathered.

[^3]: It is also our experience that grandfathering was applied on prior
    occasions when the regulation was amended to incorporate updated
    ANSI standards.