Over-the-Counter Hearing Aid Act of 2016

To provide for the regulation of over-the-counter hearing aids. 1. Short title This Act may be cited as the Over-the-Counter Hearing Aid Act of 2016 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 (o) Regulation of Over-the-Counter hearing aids (1) Definition In this subsection, the term over-the-counter hearing aid (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 . (b) Regulations To establish category (1) In general The Secretary of Health and Human Services (referred to in this section as the Secretary 21 U.S.C. 360j (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) 21 U.S.C. 360j(o) (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) (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 21 U.S.C. 301 et seq. (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

Summary: Over-the-Counter Hearing Aid Act of 2016 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 provide reasonable assurances of safety and efficacy and 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 for over-the-counter hearing aids that are not identical to FDA requirements. Until the FDA updates its draft guidance regarding hearing aids, previous draft guidance is in effect.