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(349)

333 - World Hearing Day: A Global Effort to Improve Hearing Care

333 - World Hearing Day: A Global Effort to Improve Hearing Care

Every year, World Hearing Day brings global attention to one of the most common — and often overlooked — public health challenges: hearing loss.In this discussion, experts from the World Health Organi...

24 Helmi 27min

332 - Smart Audio Meets Hearing Health: Key Takeaways from CES 2026

332 - Smart Audio Meets Hearing Health: Key Takeaways from CES 2026

What if the future of hearing technology doesn’t sit inside the ear at all? At CES 2026, one of the most important trends was the rapid rise of open-ear hearing devices — from smart hearing glasses an...

17 Helmi 30min

331 - The Convergence of AI, Audio, and Hearing Devices

331 - The Convergence of AI, Audio, and Hearing Devices

What if advanced AI noise reduction could run efficiently on standard hearing device hardware?In this episode, Dave Kemp speaks with Aernout Arends of Absolute Audio Labs and Zengyi “Boltzmann” Li of ...

11 Helmi 23min

330 - Auracast at Marriott Theatre — Audience Reactions and a Behind the Scenes Look

330 - Auracast at Marriott Theatre — Audience Reactions and a Behind the Scenes Look

What does Auracast actually feel like in a real-world performance? In this episode, Andrew Bellavia visits the Marriott Theatre near Chicago, where he was invited to personally experience Auracast dur...

9 Helmi 12min

329 - A Brain-Based Approach to Understanding and Managing Tinnitus

329 - A Brain-Based Approach to Understanding and Managing Tinnitus

What makes tinnitus distressing for some people—but barely noticeable for others?In this in-depth conversation, clinical psychologist and tinnitus researcher Dr. Jennifer Gans explains why tinnitus is...

3 Helmi 38min

328 - Hearing Aids as Fashion Tech? Inside Overtone’s Vision for the Future

328 - Hearing Aids as Fashion Tech? Inside Overtone’s Vision for the Future

What if hearing technology didn’t try to hide—but instead embraced visibility and style? In this conversation, Nick Morgan-Jones shares his personal journey with hearing loss and the stigma that kept ...

27 Tammi 24min

327 - From Ambivalence to Action: Rethinking Patient Counseling in Hearing Care

327 - From Ambivalence to Action: Rethinking Patient Counseling in Hearing Care

Why do so many people delay hearing care—even after acknowledging a problem or receiving a recommendation? In this conversation, hearing instrument specialist and researcher Bobbi-Jo Marlatt explores ...

20 Tammi 24min

326 - Can Auracast Redefine Audio Accessibility in Public Spaces?

326 - Can Auracast Redefine Audio Accessibility in Public Spaces?

What will it take for accessible audio to become the norm rather than the exception in public spaces? In this conversation, Andrew Bellavia is joined by Paul Daft of GN and journalist and accessibilit...

12 Tammi 55min

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