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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 9 Introduced in Senate (IS)]

<DOC>

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.

    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 
2016''.

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:
    ``(o) 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 to 
                compensate for perceived mild to moderate hearing 
                impairment;
                    ``(C) that includes tools to allow 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 2016 
        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 (o) 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 proposed regulations are 
        issued, 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, such as appropriate consumer 
                labeling; and
                    (B) 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(o) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(o)), 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 related to the manufacturing, 
        marketing, sale, customer support, or distribution of over-the-
        counter hearing aids (as defined in section 520(o) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(o)), 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.
    (c) Guidance.--
            (1) Withdrawal of guidance.--
                    (A) Withdrawal.--Effective as of the date of 
                enactment of this Act, the Secretary shall not use 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, as the basis 
                for any premarket review under the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 301 et seq.) or for any 
                related compliance or enforcement decisions or actions.
                    (B) Interim guidance.--Until such time as new final 
                guidance is issued under paragraph (2) to replace the 
                guidance described in subparagraph (A), the draft 
                guidance entitled ``Guidance for Industry and FDA 
                Staff: Regulatory Requirements for Hearing Aid Devices 
                and Personal Sound Amplification Products,'' issued on 
                February 25, 2009, shall be in effect.
            (2) New guidance issued.--Not later than the date on which 
        final regulations are issued under subsection (b), the 
        Secretary shall update the draft guidance described in 
        paragraph (1)(A). Such updated guidance shall clarify which 
        products, on the basis of claims or other marketing, 
        advertising, or labeling material, meet the definition of a 
        device, as defined 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.
                                 <all>
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