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H.R. 1652

Over-the-Counter Hearing Aid Act of 2017

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The FDA must update and finalize its draft guidance on hearing products.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.

Referred to the Subcommittee on Health.

Rep. Kennedy, Joseph P., III [D-MA-4](D-MA)Sponsor
14 cosponsors10 D4 R
14cosponsors1committees4actions3related bills7subjects
  1. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  2. IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  3. IntroReferralIntro-H

    Introduced in House

  4. IntroReferral1000

    Introduced in House

Over-the-Counter Hearing Aid Act of 2017 — Informed