Hearing Industries Association (HIA) - Comment

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 Medical Devices; Hearing Aids; Technical Data Amendments 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 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 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.” 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. The Office of Compliance has advised in an e mail that it understands the Proposed Rule to apply prospectively. 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