WASHINGTON, D.C. — Members of the American Academy of Audiology (AAA) and International Hearing Society (IHS) learned yesterday afternoon that the Over-The-Counter Hearing Aid Act legislation has now been attached to the Medical Device User Fee and Modernization Act (MDUFA). According to AAA President Ian Windmill, the MDUFA bill is considered “must-pass” and is scheduled to be voted on today in the assigned Senate committee.
Under the MDUFA, first passed in 2002, the FDA was given authority to collect user fees from medical device sponsors for review activities. The MDUFA was updated and reauthorized in 2007 and 2012, and the next update to the bill will be in place from October 1, 2017 through September 30, 2022.
Because the current OTC hearing aid legislation has sponsors from both political parties, and now that it has been attached to a must-pass bill, the likelihood of passage has increased significantly.
OTC Hearing Aid Legislation: Likely to Pass in 2017
IHS Past-President, Scott Beall, AuD, has stated his belief that the legislation is likely to pass between now and the end of the year. Posting on the AAA member forum, he encouraged his colleagues to help further shape the language of the bill, specifically getting section 711 “modified or removed”.
The full current draft text of section 711 is shown below for reference:
(a) IN GENERAL.-Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by section 707, is further amended by adding at the end the following:
(q) REGULATION OF OVER-THE-COUNTER HEARING AIDS.-
(1) DEFINITION.-In this subsection, the term over-the-counter hearing aid’ means a device that-
(A) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation);
(B) is intended to be used by adults over the age of 18 to compensate for perceived mild to moderate hearing impairment;
C) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs;
(i) use wireless technology; or
(ii) include tests for self-assessment of hearing loss; and
(E) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.
(2) REGULATION.-An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 710(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations).
(b) REGULATIONS TO ESTABLISH CATEGORY.-
(1) IN GENERAL.-The Secretary of Health and Human Services (referred to in this section as the Secretary”), not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.
(2) REQUIREMENTS.-In promulgating the regulations under paragraph (1), the Secretary shall-
(A) include requirements that provide reasonable assurances of the safety and efficacy of over-the-counter hearing aids;
(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;
(C) include requirements for appropriate labeling of the over-the-counter hearing aid, including how consumers may report adverse events, any conditions or contraindications, and any advisements to consult promptly with a licensed physician; and
(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.
(3) PREMARKET NOTIFICATION.-The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by subsection (a)) require a report under section 510(k) to provide reasonable assurance of safety and effectiveness.
(4) EFFECT ON STATE LAW.-No State or local government shall establish or continue in effect any law, regulation, or order specifically applicable to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.
(e) NEW GUIDANCE ISSUED.-Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled, ”Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”, issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance.
(d) STUDY.-Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report evaluating consumer experience with hearing health care, hearing screening in the primary care setting, and consumer adoption, usage, and outcomes related to hearing technology. The Comptroller General shall update such report not later than 2 years after the final regulations described in subsection (b) are issued, and shall evaluate how implementation of such regulations has impacted hearing health care, including recommendations for improving consumer access to appropriate hearing health care.
OTC Bill Committee Vote
It has come to our attention that the anticipated vote today in the Senate HELP committee on the MDUFA bill, with attached OTC hearing aid legislation, has been postponed in light of the Senate Democratic Caucus holding an emergency meeting to discuss the sudden and unexpected dismissal of FBI Director James Comey.
Post-Publication Update: 5/11/17
The Senate HELP committee held a hearing today at 9:30am, which included discussion of the MDUFA bill. During this morning’s hearing, committee Chairman Sen. Lamar Alexander (R-TN) urged his colleagues to keep the MDUFA bill as bi-partisan as possible and avoid “controversial amendments” that could slow down the process to get the legislation through the Senate and House and onto the President’s desk by July.
The Senate HELP committee later passed the FDA bill with almost unanimous support, by a vote of 21-2. A full recording of the hearing can be watched here.
After delaying the mark up by one day, the Senate Health Education Labor and Pensions (HELP) Committee met on Thursday, May 11 to consider legislation (S. 934) that would reauthorize the US Food and Drug Administration (FDA) drug and device user fees. Before voting, the Senate HELP Committee unanimously adopted the manager’s amendment released on May 8. The manager’s amendment included a number of added provisions, including one that directs the FDA to develop a category of over-the-counter hearing aids. The Senate HELP Committee then voted to approve the device user fee package. This legislation, including the OTC hearing aid provision, will now move to the full Senate for consideration. The current authorization for the user fees expires on September 30 so we anticipate the Senate to act quickly on this legislation.
—American Academy of Audiology, May 11, 2017
Post-Publication Update: 6/8/17
On June 7, the House Energy and Commerce (E&C) Committee held a markup on the FDA Reauthorization Act of 2017. During the markup, changes were made to the OTC hearing aid provision which included the addition of language that strengthens labeling requirements to ensure consumers understand that OTC devices are only intended for adults over the age of 18. Additionally, the amended language also directs HHS to analyze and report adverse events related to OTC hearing aid devices to Congress no later than two years after the regulations are finalized.
According to a AAA news release, Rep. David McKinley also submitted an amendment with language that would have OTC devices include access to a test performed by a licensed hearing care professional. The amendment, however, was later withdrawn.
The House E&C Committee unanimously voted the legislation out of the committee and the bill will now go to the full House of Representatives for final consideration.