text: 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.
target: 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.
feat_title: Over-the-Counter Hearing Aid Act of 2017