Breaking Down the OTC Hearing Aid Guidelines: A Closer Look at the New Regulations

The recent release of the final FDA guidelines on over-the-counter (OTC) and prescriptive hearing aid categories is detailed and complex.

In this episode, Amyn Amlani is joined by David Akbari, Senior Medical Science, Clinical and Regulatory Affairs Liaison at Intricon Corporation, to help breakdown the new regulations. Dr. Akbari provides viewers with an overview of the guidelines and their potential effect on professional scope and business practice.

Karl Strom piece referenced in discussion can be found here:

Be sure to subscribe to our YouTube channel for the latest episodes each week, and follow This Week in Hearing on LinkedIn and Twitter:

Prefer to listen on the go? Tune into the TWIH Podcast on your favorite podcast streaming service, including Apple, Spotify, Google and more.

-Timestamps-
00:00 Introduction
01:46 OTC Legislation Development
03:43 What are OTC Hearing Aids?
08:26 Technical Standards for OTC Hearing Aids
16:00 Volume Control Requirement
17:36 Self Fitting vs. Customization
19:33 Labeling Requirements
21:40 Eartip Insertion Depth
24:35 510k Clearance
28:32 OTC Hearing Aid Candidacy
32:45 Output and Gain Requirements
36:45 OTC Hearing Aid Consumer Protections
38:58 Prescriptive Hearing Aids
43:08 Changes to Prescrptive Hearing Aid Fitting