II 

114TH CONGRESS 

2D SESSION S. 9 

To provide for the regulation of over-the-counter hearing aids. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 1, 2016 

Ms. WARREN (for herself and Mr. GRASSLEY) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the regulation of over-the-counter hearing 

aids. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Over-the-Counter 

5 Hearing Aid Act of 2016’’. 

6 SEC. 2. REGULATION OF OVER-THE-COUNTER HEARING 

7 AIDS. 

8 (a) IN GENERAL.—Section 520 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by 

10 adding at the end the following: 


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1 ‘‘(o) REGULATION OF OVER-THE-COUNTER HEARING

2 AIDS.— 

3 ‘‘(1) DEFINITION.—In this subsection, the term 

4 ‘over-the-counter hearing aid’ means a device— 

5 ‘‘(A) that uses the same fundamental sci6 entific technology as air conduction hearing 

7 aids (as defined in section 874.3300 of title 21, 

8 Code of Federal Regulations) (or any successor 

9 regulation) or wireless air conduction hearing 

10 aids (as defined in section 874.3305 of title 21, 

11 Code of Federal Regulations) (or any successor 

12 regulation); 

13 ‘‘(B) that is intended to be used by adults 

14 to compensate for perceived mild to moderate 

15 hearing impairment; 

16 ‘‘(C) that includes tools to allow the user 

17 to control the over-the-counter hearing aid and 

18 customize it to the user’s hearing needs; 

19 ‘‘(D) that may— 

20 ‘‘(i) use wireless technology; or 

21 ‘‘(ii) include tests for self-assessment 

22 of hearing loss; and 

23 ‘‘(E) that is available over-the-counter, 

24 without the supervision, prescription, or other 

25 order, involvement, or intervention of a licensed 


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1 person, to consumers through in-person trans2 actions, by mail, or online. 

3 ‘‘(2) REGULATION.—An over-the-counter hear4 ing aid shall be subject to the regulations promul5 gated in accordance with section 2(b) of the Over6 the-Counter Hearing Aid Act of 2016 and shall be 

7 exempt from sections 801.420 and 801.421 of title 

8 21, Code of Federal Regulations (or any successor 

9 regulations).’’. 

10 (b) REGULATIONS TO ESTABLISH CATEGORY.— 

11 (1) IN GENERAL.—The Secretary of Health and 

12 Human Services (referred to in this section as the 

13 ‘‘Secretary’’), not later than 3 years after the date 

14 of enactment of this Act, shall promulgate proposed 

15 regulations to establish a category of over-the16 counter hearing aids, as defined in subsection (o) of 

17 section 520 of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360j) as amended by sub19 section (a), and, not later than 180 days after the 

20 date on which the proposed regulations are issued, 

21 shall issue such final regulations. 

22 (2) REQUIREMENTS.—In promulgating the reg23 ulations under paragraph (1), the Secretary shall— 

24 (A) include requirements that provide rea25 sonable assurances of the safety and efficacy of 


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1 over-the-counter hearing aids, such as appro2 priate consumer labeling; and 

3 (B) describe the requirements under which 

4 the sale of over-the-counter hearing aids is per5 mitted, without the supervision, prescription, or 

6 other order, involvement, or intervention of a li7 censed person, to consumers through in-person 

8 transactions, by mail, or online. 

9 (3) PREMARKET NOTIFICATION.—The Sec10 retary shall make findings under section 510(m) of 

11 the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 360(m)) to determine whether over-the13 counter hearing aids (as defined in section 520(o) of 

14 the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 360j(o)), as amended by subsection (a)) re16 quire a report under section 510(k) to provide rea17 sonable assurance of safety and effectiveness. 

18 (4) EFFECT ON STATE LAW.—No State or local 

19 government shall establish or continue in effect any 

20 law, regulation, order, or other requirement related 

21 to the manufacturing, marketing, sale, customer 

22 support, or distribution of over-the-counter hearing 

23 aids (as defined in section 520(o) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 360j(o)), 

25 as amended by subsection (a)) through in-person 


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1 transactions, by mail, or online, that is different 

2 from, in addition to, or otherwise not identical to, 

3 the regulations promulgated under this subsection. 

4 (c) GUIDANCE.— 

5 (1) WITHDRAWAL OF GUIDANCE.— 

6 (A) WITHDRAWAL.—Effective as of the 

7 date of enactment of this Act, the Secretary 

8 shall not use the draft guidance of the Depart9 ment of Health and Human Services entitled, 

10 ‘‘Regulatory Requirements for Hearing Aid De11 vices and Personal Sound Amplification Prod12 ucts’’, issued on November 7, 2013, as the 

13 basis for any premarket review under the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

15 301 et seq.) or for any related compliance or 

16 enforcement decisions or actions. 

17 (B) INTERIM GUIDANCE.—Until such time 

18 as new final guidance is issued under paragraph 

19 (2) to replace the guidance described in sub20 paragraph (A), the draft guidance entitled 

21 ‘‘Guidance for Industry and FDA Staff: Regu22 latory Requirements for Hearing Aid Devices 

23 and Personal Sound Amplification Products,’’ 

24 issued on February 25, 2009, shall be in effect. 


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1 (2) NEW GUIDANCE ISSUED.—Not later than 

2 the date on which final regulations are issued under 

3 subsection (b), the Secretary shall update the draft 

4 guidance described in paragraph (1)(A). Such up5 dated guidance shall clarify which products, on the 

6 basis of claims or other marketing, advertising, or 

7 labeling material, meet the definition of a device, as 

8 defined in section 201 of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 321) and which prod10 ucts meet the definition of a personal sound amplifi11 cation product, as set forth in such guidance. 

Æ 


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