086 - OTC Hearing Aids: Hearing Device Manufacturers Share Perspective on FDA's Final Regulations

086 - OTC Hearing Aids: Hearing Device Manufacturers Share Perspective on FDA's Final Regulations

In 2022 the FDA has now finally issued its final regulations for over-the-counter (OTC) hearing aids in the United States. Many years in the making, as part of the development of the OTC guidelines, the FDA received input from various stakeholders, including those who actually manufacture hearing devices for people with hearing loss.

After commenting on the draft regulations that were issued in early 2021, how does the industry feel about the changes that were made in the final rule issued by the FDA? Do they believe the prescriptive hearing aid market will change significantly due to OTC? What risks or concerns do they have?

In this special episode, we hear from representatives of four hearing device manufacturers: *Dave Fabry, PhD, Starkey *Gary Rosenblum, Oticon, Inc *Laurel Christensen, PhD, GN Hearing *John Luna, Nuheara

We also sought out opinions from consumers and from hearing professionals, which can be viewed below:

  • Consumer Perspective on OTC: https://youtu.be/91g639J7PoE
  • Professional Perspective on OTC: https://youtu.be/5IE0TwZ54kc

Jaksot(351)

049 - Reaching More People with Hearing Loss: Interview with Anthony Florek and Chris Boven of Soundwave Hearing

049 - Reaching More People with Hearing Loss: Interview with Anthony Florek and Chris Boven of Soundwave Hearing

In January of 2022, Soundwave Hearing announced the launch of its new self-fitting Sontro AI hearing aids and mobile app. In this week's episode, Soundwave CEO, Anthony Florek, and company CTO, Chris...

29 Maalis 202223min

048 - History and Evolution of Balanced Armature Receivers and Personalized Audio with Matt Skindzier of Knowles

048 - History and Evolution of Balanced Armature Receivers and Personalized Audio with Matt Skindzier of Knowles

As hearing aids and consumer audio devices converge, a wider range of people with hearing difficulties will have choices on the type of product they want to wear. At the heart of this convergence are ...

24 Maalis 202222min

047 - OTC Hearing Aid Regulation - Has the FDA's Proposal Become Obsolete Before it Even Begins?

047 - OTC Hearing Aid Regulation - Has the FDA's Proposal Become Obsolete Before it Even Begins?

Is it possible that the FDA's proposed rule on OTC hearing aids is obsolete, even before it becomes finalized? Andy Bellavia and Dave Kemp discuss how the long-awaited regulations from the FDA may alr...

22 Maalis 202245min

046 - Diabetes Management and the Role of the Audiologist: Interview with Kathy Dowd, AuD

046 - Diabetes Management and the Role of the Audiologist: Interview with Kathy Dowd, AuD

This week, Dr. Kathy Dowd, Executive Director of The Audiology Project, joins host Amyn Amlani in discussing the connection between hearing loss and diabetes, as well as the role audiologists play in ...

15 Maalis 202225min

045 - Audiology Beyond Hearing: Opportunities in Assessment of Cognitive, Balance and Vestibular Function

045 - Audiology Beyond Hearing: Opportunities in Assessment of Cognitive, Balance and Vestibular Function

In today's episode, Dr. Richard Gans, the Executive Director and Founder of the American Institute of Balance, and Tom O'Neill, the President and CEO of Cognivue, join Dave Kemp to discuss the benefit...

8 Maalis 202246min

044 - Promoting Hearing Health By Design - Interview with Tom Woods of Hearing Birdsong

044 - Promoting Hearing Health By Design - Interview with Tom Woods of Hearing Birdsong

A group in the United Kingdom has re-innovated how to test hearing sensitivity using five bird calls in a forest soundscape. The bird calls are digitized and occupy similar frequencies to that of a tr...

3 Maalis 202230min

043 - Combating Chronic Vertigo: Interview with Sam Owen and Didier Depireux of Otolith Labs

043 - Combating Chronic Vertigo: Interview with Sam Owen and Didier Depireux of Otolith Labs

Otolith Labs is pioneering the first medical wearable for the treatment of vertigo, a symptom experienced by more than 15 million Americans. Company CEO, Samuel Owen, and Chief Science Officer, Dr. Di...

1 Maalis 202227min

042- App Based Tinnitus Management: Interview with Ed Farrar and Anna Pugh of Oto

042- App Based Tinnitus Management: Interview with Ed Farrar and Anna Pugh of Oto

This week, host Dave Kemp is joined by Dr. Edmund Farrar and Anna Pugh of UK-based startup: Oto Oto is an app-based digital health solution for people suffering from tinnitus. Over the past year, the...

23 Helmi 202232min

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