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

Avsnitt(352)

344 - Sound Preference: Bridging the Gap in Hearing Aid Fit and Satisfaction

344 - Sound Preference: Bridging the Gap in Hearing Aid Fit and Satisfaction

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343 - How PowerPoint Captions Helped Everyone Follow Along

343 - How PowerPoint Captions Helped Everyone Follow Along

What happens when a once-in-a-lifetime travel experience is made truly accessible?In this conversation, Shari Eberts speaks with Dr. Alison Richard—former Provost of Yale and a leading primatologist—a...

14 Apr 28min

342 - A Brain-Based Approach to Tinnitus (Part 2): Making Sense of Treatment Options

342 - A Brain-Based Approach to Tinnitus (Part 2): Making Sense of Treatment Options

In Part 2 of this conversation, the focus shifts from understanding tinnitus to how it’s actually managed.Dr. Jennifer Gans returns to speak with Shari Eberts about tinnitus management strategies. Bui...

8 Apr 39min

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 Mars 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 Mars 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 Mars 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 Mars 19min

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