Over-the-Counter Hearing Aid Act of 2017

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 The FDA must update and finalize its draft guidance on hearing products.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

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Timeline

1. 21 March 2017

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 21 March 2017

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 21 March 2017 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 21 March 2017

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 21 March 2017

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 21 March 2017

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Warren, Elizabeth [D-MA] · D · Sponsor
• Sen. Grassley, Chuck [R-IA] · R · Sponsor
• Sen. Hassan, Margaret Wood [D-NH] · D · Sponsor
• Sen. Isakson, Johnny [R-GA] · R · Sponsor
• Sen. Collins, Susan M. [R-ME] · R · Cosponsor
• Sen. McCaskill, Claire [D-MO] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to ← Over-the-Counter Hearing Aid Act of 2017
• related to ← FDA Reauthorization Act of 2017
• related to ← FDA Reauthorization Act of 2017