FDA seeks input on over-the-counter hearing devices

September 16, 2019

The U.S. Food and Drug Administration (FDA) issued two notices related to hearing aids, referencing the President’s Council of Advisors on Science and Technology (PCAST) report to the President: Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. (A PCAST report summary can be found here and the full report can be found here.) The FDA is also mindful of the ongoing efforts of the Committee on Accessible and Affordable Hearing Health Care for Adults at the Institute of Medicine (IOM).

The two notices are in reference to:

Reopening the comment period on the Personal Sound Amplification Products (PSAPs) Draft Guidance
When the FDA issued the Draft Guidance on PSAPs, it allowed a period of public comment, to which HLAA submitted comments. In light of the PCAST and IOM activities, the FDA is reopening the public comment period. The deadline for comments is May 4, 2016.

The FDA asks parties to comment on three issues raised by PCAST:

  • The degree to which current FDA requirements are a barrier to hearing aid accessibility, affordability and use;
  • The appropriateness of creating a category of “basic” hearing aids with labeling for OTC sale;
  • Whether or not the benefits of OTC hearing aids would outweigh the risks of foregoing the requirement of medical evaluation.

An FDA Public Workshop on Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids – April 21, 2016
Reacting to the PCAST recommendation that the FDA exempt hearing aids from the Quality System Regulations (QSRs), a public workshop is being convened by the FDA to discuss the current QSRs and GMPs for hearing aids and to consider an alternative model for quality verification. The FDA will also consider the possible use of alternative quality standards developed by standards development organizations and key stakeholders. The workshop is open to the public, but requires registration by April 13, 2016. Written comments can be submitted until May 19, 2016.

HLAA will be submitting comments and plans to participate in the Public Workshop on April 21, 2016.