Academy Submits Comments to the FDA

We recognize that Academy members are working in very challenging times and the Academy continues to work on behalf of our members. We are committed to making sure Academy members are prepared for changes that affect the profession and we will be a resource for the latest information and advocacy.

As an example, on November 10, (Regulation of Over-the-Counter Hearing Aids (Part 1 of 2): Overview), the Academy launched a new member-only web seminar series, “Join the Discussion.” These interactive seminars will take place to inform and engage Academy members on current issues that impact audiology. 

Our most recent seminar, Regulation of Over-the-Counter (OTC) Hearing Aids (Part 2): Academy Analysis of the FDA Proposed Rule and Implications for the Profession (December 8), the Academy provided a forum for members to engage in discussion about the Food and Drug Administration’s (FDA) proposed regulations for OTC hearing aids. Members can still access this web seminar on-demand to learn more about the regulations.

The Academy has submitted comments to the FDA in response to the proposed rule Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids. A subject-matter expert work group of Academy members drafted comments that focus on patient safety, efficacy, consumer protection, and the potential for unintended consequences. The Academy board approved final comments for submission by the organization and also encourages members to submit individual comments.

The work group also prepared a useful comparison table of the legislative mandate for OTC hearing aids (FDAR) with the proposed rule. Feel free to use this information when developing your own comments.

Throughout next year, we will continue to provide OTC-related resources to assist members in navigating these changes in the health care delivery system with an emphasis on how OTC devices may affect the profession.

The Academy looks forward to bringing members additional, timely “Join the Discussion” web seminars and invites members to engage with their colleagues. Future topics include the legislative updates, status of Medicare Audiologist Access and Services Act (H.R. 1587/S. 1731); telehealth; diversity, equity, and inclusion in clinical education; and more. 

Academy members are welcome to submit other topics for the Academy to address in upcoming sessions along with other aspects of the OTC issue, please contact us with suggestions.