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A bill to provide for the regulation of over-the-counter hearing aids.

USA115th CongressS-670| Senate 
| Updated: 3/21/2017
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Cosponsors (5)
Margaret Wood Hassan (Democratic)Claire McCaskill (Democratic)Johnny Isakson (Republican)Susan M. Collins (Republican)Chuck Grassley (Republican)

Health, Education, Labor, and Pensions 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 The FDA must update and finalize its draft guidance on hearing products.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
Introduced in Senate
Mar 21, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 24, 2017

Latest Companion Bill Action

HR 115-1652
Referred to the Subcommittee on Health.
  • March 21, 2017
    Introduced in Senate


  • March 21, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • March 24, 2017

    Latest Companion Bill Action

    HR 115-1652
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 115-2430: FDA Reauthorization Act of 2017
  • HR 115-1652: To provide for the regulation of over-the-counter hearing aids.
  • S 115-934: FDA Reauthorization Act of 2017
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

A bill to provide for the regulation of over-the-counter hearing aids.

USA115th CongressS-670| Senate 
| Updated: 3/21/2017
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
Introduced in Senate
Mar 21, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 24, 2017

Latest Companion Bill Action

HR 115-1652
Referred to the Subcommittee on Health.
  • March 21, 2017
    Introduced in Senate


  • March 21, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • March 24, 2017

    Latest Companion Bill Action

    HR 115-1652
    Referred to the Subcommittee on Health.
Elizabeth Warren

Elizabeth Warren

Democratic Senator

Massachusetts

Cosponsors (5)
Margaret Wood Hassan (Democratic)Claire McCaskill (Democratic)Johnny Isakson (Republican)Susan M. Collins (Republican)Chuck Grassley (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 115-2430: FDA Reauthorization Act of 2017
  • HR 115-1652: To provide for the regulation of over-the-counter hearing aids.
  • S 115-934: FDA Reauthorization Act of 2017
  • 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