Over-the-Counter Hearing Aid Act of 2017

HB 1652 Over the Counter Hearing Aid Act of 2017

US Congress 115th Congress

Over-the-Counter Hearing Aid Act of 2017
HB-1652


About HB-1652

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 The FDA must update and finalize its draft guidance on hearing products.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

  

Bill Texts

Introduced 03/23/2017

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History

Referred To The Subcommittee On Health.

03/24/2017

Introduced In House

03/21/2017

Referred To The House Committee On Energy And Commerce.

03/21/2017