Over-the-Counter Hearing Aid Act of 2017

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 2017 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 (p) 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 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 . (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; (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) 21 U.S.C. 360j (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 (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 21 U.S.C. 321

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.