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)

302 - Connecting Hearing and Health: Collaboration, Cognition, and the Future of Care

302 - Connecting Hearing and Health: Collaboration, Cognition, and the Future of Care

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301 - Phonak Virto R Infinio Custom Hearing Aids: Exploring Fit, Features, and First Impressions

301 - Phonak Virto R Infinio Custom Hearing Aids: Exploring Fit, Features, and First Impressions

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300 - Inside the Cochlear Nexa Implant System: Advancing Hearing Outcomes Through Innovation

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299 - OCT Imaging Reveals New Insights into Meniere’s Disease and Other Inner Ear Disorders

299 - OCT Imaging Reveals New Insights into Meniere’s Disease and Other Inner Ear Disorders

For the first time, optical coherence tomography (OCT) is being used to study the human inner ear directly in patients. In this follow-up conversation, Dr. John Oghalai, Professor and Chair of the Car...

21 Elo 202523min

298 - Exploring ReSound Enzo IA Hearing Aids: Super-Power Performance, Advanced Connectivity, and More

298 - Exploring ReSound Enzo IA Hearing Aids: Super-Power Performance, Advanced Connectivity, and More

ReSound has introduced the Enzo IA, its newest super-power hearing aid built for people with severe-to-profound hearing loss. Smaller and rechargeable, Enzo IA offers up to 28 hours of battery life wh...

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297 - From Recipient to Advocate: Angela Irwin’s Mission to Support Cochlear Implant Users

297 - From Recipient to Advocate: Angela Irwin’s Mission to Support Cochlear Implant Users

What happens when the technology that restores your hearing comes with ongoing costs that insurance often won’t cover? Angela Irwin—bilateral cochlear implant recipient, TEDx speaker, confidence coach...

14 Elo 202523min

296 - Therapeutic Approaches to Hidden Hearing Loss with Celia Belline, CEO of Cilcare

296 - Therapeutic Approaches to Hidden Hearing Loss with Celia Belline, CEO of Cilcare

What if we could treat hearing loss before it shows up on a standard audiogram? Celia Belline, CEO and co-founder of Cilcare, shares progress on the company’s lead compound, CIL001, developed to treat...

7 Elo 202517min

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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