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(350)

295 - Combining Technology and Human Touch to Improve Access for the Deaf Community

295 - Combining Technology and Human Touch to Improve Access for the Deaf Community

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294 - How Hearing Loss Inspired a Life of Art and Advocacy

294 - How Hearing Loss Inspired a Life of Art and Advocacy

What happens when hearing loss shapes an artist’s path? Priscila Soares—a Brazilian-American artist, illustrator, and mother—draws on her experience with single-sided deafness and raising a child with...

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293 - Bringing the Patient Voice Into Audiology Education

293 - Bringing the Patient Voice Into Audiology Education

What happens when audiology students learn directly from people living with hearing loss?In this episode, Shari Eberts talks with Dr. Kathleen Cienkowski, audiologist and professor at the University o...

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292 - How GN and Han Kjøbenhavn Used Fashion to Challenge Hearing Aid Stigma

292 - How GN and Han Kjøbenhavn Used Fashion to Challenge Hearing Aid Stigma

What happens when a global hearing aid manufacturer and a fashion house join forces to challenge stigma?In this episode, host Andrew Bellavia speaks with Marie Schleimann Nordlund, Director of Communi...

16 Jul 202525min

291 - Making Guided Meditation More Accessible for People with Hearing Loss

291 - Making Guided Meditation More Accessible for People with Hearing Loss

For many with hearing loss, traditional meditation practices fall short—one woman is working to change that. Janaki Zaremba is a lifelong meditator who also lives with hearing loss, she’s developing a...

14 Jul 202521min

290 - Giants of Audiology: Interview with Tena McNamara, AuD

290 - Giants of Audiology: Interview with Tena McNamara, AuD

Dr. Tena McNamara’s audiology journey has spanned clinical practice, academic leadership, advocacy, and national service. With more than four decades of experience and dual certification in audiology ...

10 Jul 202555min

289 - Exploring Phonak’s Approach to Real-World Hearing Aid Testing

289 - Exploring Phonak’s Approach to Real-World Hearing Aid Testing

Hearing care professionals often face challenges when trying to evaluate and compare performance claims across hearing aid brands. Andrew Bellavia speaks with Michael Preuss, Audiology Manager at Sono...

7 Jul 202523min

288 - Improving Hearing Care Access in Underserved Regions Through Community-Based Training

288 - Improving Hearing Care Access in Underserved Regions Through Community-Based Training

What does it take to build sustainable hearing care infrastructure in underserved regions of the world? In this inspiring interview, Andrew Bellavia is joined by Richard Brown, Chairman and President ...

2 Jul 202543min

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