Title: Over-the-Counter Hearing Aid Act of 2017
Policy area: Health

Summary:
Over-the-Counter Hearing Aid Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.
State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.
The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 670 Introduced in Senate (IS)]

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115th CONGRESS
  1st Session
                                 S. 670

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 21, 2017

  Ms. Warren (for herself, Mr. Grassley, Ms. Hassan, and Mr. Isakson) 
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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Over-the-Counter Hearing Aid Act of 
2017''.

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

    (a) In General.--Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the 
following:
    ``(p) Regulation of Over-the-Counter Hearing Aids.--
            ``(1) Definition.--In this subsection, the term `over-the-
        counter hearing aid' means a device--
                    ``(A) that 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) that is intended to be used by adults over 
                the age of 18 to compensate for perceived mild to 
                moderate hearing impairment;
                    ``(C) that, 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;
                    ``(D) that may--
                            ``(i) use wireless technology; or
                            ``(ii) include tests for self-assessment of 
                        hearing loss; and
                    ``(E) that 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 2(b) of the Over-the-Counter Hearing Aid 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 (p) 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(p) 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, 
        order, or other requirement 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(p) 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.
    (c) 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.
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