Tuesday, 30 November 2021

FDA Proposed OTC Hearing Aid Rule Comment Period Closes January 18, 2022

Posted in ADA News

ADA Analysis Underway

On October 20, 2021, the U.S. Food and Drug Administration (FDA) released a Proposed Rule Establishing Over-the-Counter Hearing Aids (Proposed Rule) with a 90-day deadline for comments (due by January 18, 2022).

The rulemaking process follows President Biden’s Executive Order of July 9, 2021 and initiates implementation of the Over-the-Counter Hearing Aid Act, ADA-supported, bipartisan legislation that was passed and signed into law as part of the FDA Reauthorization Act (FDARA) in 2017. FDARA directs the FDA to create a category of Over-the-Counter Hearing and develop regulations of OTC hearing aids that do the following:

  • Provide reasonable assurances of safety and efficacy;
  • Establish output limits and labeling requirements; and
  • Describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.

ADA is diligently analyzing the Proposed Rule against the statutory requirements imposed by FDARA, alignment with ADA’s commitment to the delivery of evidence-based audiology services, professional autonomy for audiologists, and patient access and choice, and the degree to which the Proposed Rule specifically mitigates concerns brought forward by ADA’s 2021 Issue Brief, State Laws and Hearing Aid Sales: Home Field Advantage or House of Cards.

ADA will hold a Members-Only Town Hall Session in early January prior to the end of the comment period to present ADA’s analysis of the Proposed Rule and ADA’s draft comments for member input (more information coming soon). ADA will also provide members with a template to use to submit individual comments to the FDA.