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

Episoder(349)

341 - Giants of Audiology: Interview with Harvey Dillon, PhD

341 - Giants of Audiology: Interview with Harvey Dillon, PhD

Dr. Harvey Dillon’s career in audiology spans more than four decades of research, innovation, and leadership that have helped shape modern hearing care around the world. A former Director of the Natio...

1 Apr 54min

340 - NAL-NL3: What’s Changing in Hearing Aid Fitting—and Why It Matters

340 - NAL-NL3: What’s Changing in Hearing Aid Fitting—and Why It Matters

The NAL-NL3 fitting algorithm is now entering clinical practice, following GN’s recent global rollout—marking a significant evolution from the widely used NL2 standard. In this discussion, Pádraig Kit...

30 Mar 31min

339 - Hearing Loss and Media: Bridging the Gap Between Perception and Reality

339 - Hearing Loss and Media: Bridging the Gap Between Perception and Reality

Hearing loss affects millions of people across all ages—but you wouldn’t know it from mainstream media. New data from a multi-country survey reveals just how rarely hearing aids and cochlear implants ...

25 Mar 27min

338 - The Evolution of Cochlear Implants and the Cochlear Care Consensus

338 - The Evolution of Cochlear Implants and the Cochlear Care Consensus

How has cochlear implant care evolved—and are clinical practices keeping pace with today’s technology?Brian Taylor speaks with Dr. Terry Zwolan, Senior Director of Medical Affairs at Cochlear Americas...

23 Mar 22min

337 - MED-EL Remote Care: Supporting CI Patients Beyond the Clinic Visit

337 - MED-EL Remote Care: Supporting CI Patients Beyond the Clinic Visit

What if cochlear implant care didn’t always require a trip to the clinic? Host Shari Eberts speaks with Dr. Kensi Saia, Product Manager at MED-EL, about how new telehealth tools are changing the way c...

18 Mar 19min

336 - Symposium Preview: Quest for the Best in CAPD and Neuroaudiology Returns for Its Third Year

336 - Symposium Preview: Quest for the Best in CAPD and Neuroaudiology Returns for Its Third Year

Central Auditory Processing Disorder (CAPD) remains one of the more complex and often misunderstood areas in audiology. In this week’s episode of This Week in Hearing, host Bob Traynor is joined by Dr...

16 Mar 17min

335 - Holistic Hearing Care and the Tinnitus Patient

335 - Holistic Hearing Care and the Tinnitus Patient

Tinnitus care is no longer just about masking sound—it’s about treating the whole person.This week, Shari Eberts speaks with Dr. Maren Stropahl, Senior Director of Holistic Hearing Care and Head of Au...

12 Mar 24min

334 - ELEHEAR’s David Hogan Talks OTC Hearing Aids and the Future of Consumer Hearing Tech

334 - ELEHEAR’s David Hogan Talks OTC Hearing Aids and the Future of Consumer Hearing Tech

How are over-the-counter (OTC) hearing aids evolving as the market continues to develop? This week, host Bob Traynor speaks with David Hogan, Managing Director of ELEHEAR, about the growth of the OTC ...

9 Mar 34min

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