HR 1652 115th Congress House Health Administrative law and regulatory procedures Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Hearing, speech, and vision care Marketing and advertising

Over-the-Counter Hearing Aid Act of 2017

Introduced: March 21, 2017 See on congress.gov

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Mar 24, 2017

Referred to the Subcommittee on Health.

Mar 21, 2017

Referred to the House Committee on Energy and Commerce.

Mar 21, 2017

Introduced in House

Plain-English summary Congressional Research Service

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The FDA must update and finalize its draft guidance on hearing products.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

What's happening now March 24, 2017

Referred to the Subcommittee on Health.

Committees of jurisdiction 2