In this 35-minute podcast, well-known hearing industry audiologist Thomas Powers, PhD, and Hearing Review Editor Karl Strom talk about four noteworthy parts of the proposed OTC hearing aid regulations:

 1) Output limits for these new devices;

2) The return-for-credit policies, and if consumers will have some kind of recourse if the hearing device doesn’t work for them;

3) The somewhat wonky area of 510k premarket clearance relative to “wear and go” vs “self-fitting” OTC devices, and why it could be important; and

4) One of the most confusing and potentially consequential parts of the FDA’s proposed regulations: the pre-emption of state laws and what this might actually mean for hearing care professionals, their practices, and state licensing boards.

 Dr Powers also speaks to labeling issues and provides his advice about how hearing care practices and their staff members might prepare for the advent of OTC hearing aids.

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