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To provide for the regulation of over-the-counter hearing aids.

USA115th CongressHR-1652| House 
| Updated: 3/24/2017
Joseph P. Kennedy

Joseph P. Kennedy

Democratic Representative

Massachusetts

Cosponsors (14)
Brian Higgins (Democratic)Marsha Blackburn (Republican)Carol Shea-Porter (Democratic)Niki Tsongas (Democratic)Debbie Dingell (Democratic)Earl L. "Buddy" Carter (Republican)Collin C. Peterson (Democratic)Don Bacon (Republican)Eleanor Holmes Norton (Democratic)Jamie Raskin (Democratic)James P. McGovern (Democratic)Yvette D. Clarke (Democratic)Zoe Lofgren (Democratic)Vern Buchanan (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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 The FDA must update and finalize its draft guidance on hearing products.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
Mar 21, 2017

Latest Companion Bill Action

S 115-670
Introduced in Senate
Mar 21, 2017
Introduced in House
Mar 21, 2017
Referred to the House Committee on Energy and Commerce.
Mar 24, 2017
Referred to the Subcommittee on Health.
  • March 21, 2017

    Latest Companion Bill Action

    S 115-670
    Introduced in Senate


  • March 21, 2017
    Introduced in House


  • March 21, 2017
    Referred to the House Committee on Energy and Commerce.


  • March 24, 2017
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 115-2430: FDA Reauthorization Act of 2017
  • S 115-934: FDA Reauthorization Act of 2017
  • S 115-670: A bill to provide for the regulation of over-the-counter hearing aids.
Administrative law and regulatory proceduresConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesHearing, speech, and vision careMarketing and advertising

To provide for the regulation of over-the-counter hearing aids.

USA115th CongressHR-1652| House 
| Updated: 3/24/2017
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Mar 21, 2017

Latest Companion Bill Action

S 115-670
Introduced in Senate
Mar 21, 2017
Introduced in House
Mar 21, 2017
Referred to the House Committee on Energy and Commerce.
Mar 24, 2017
Referred to the Subcommittee on Health.
  • March 21, 2017

    Latest Companion Bill Action

    S 115-670
    Introduced in Senate


  • March 21, 2017
    Introduced in House


  • March 21, 2017
    Referred to the House Committee on Energy and Commerce.


  • March 24, 2017
    Referred to the Subcommittee on Health.
Joseph P. Kennedy

Joseph P. Kennedy

Democratic Representative

Massachusetts

Cosponsors (14)
Brian Higgins (Democratic)Marsha Blackburn (Republican)Carol Shea-Porter (Democratic)Niki Tsongas (Democratic)Debbie Dingell (Democratic)Earl L. "Buddy" Carter (Republican)Collin C. Peterson (Democratic)Don Bacon (Republican)Eleanor Holmes Norton (Democratic)Jamie Raskin (Democratic)James P. McGovern (Democratic)Yvette D. Clarke (Democratic)Zoe Lofgren (Democratic)Vern Buchanan (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 115-2430: FDA Reauthorization Act of 2017
  • S 115-934: FDA Reauthorization Act of 2017
  • S 115-670: A bill to provide for the regulation of over-the-counter hearing aids.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesHearing, speech, and vision careMarketing and advertising