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(351)

304 - Regenerative Cell Therapy for Hearing Loss: Rincell-1 from Rinri Therapeutics

304 - Regenerative Cell Therapy for Hearing Loss: Rincell-1 from Rinri Therapeutics

Can regenerative medicine move beyond managing symptoms to actually restore natural hearing?Brian Taylor speaks with Simon Chandler, CEO of Rinri Therapeutics, about the company’s pioneering cell ther...

11 Sep 202520min

303 - Regenerative Therapies for Sudden Hearing Loss: AC102 from AudioCure

303 - Regenerative Therapies for Sudden Hearing Loss: AC102 from AudioCure

What if a regenerative therapy could not only halt sudden hearing loss but also help the inner ear repair itself? Dr. Reimar Schlingensiepen, CEO of Berlin-based biotech AudioCure, joins Brian Taylor ...

4 Sep 202525min

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

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

Madison Levine sits down with Dave Kemp to share her journey from founding a private practice to shaping it into a clinic that bridges hearing care with the wider healthcare system, emphasizing the ro...

2 Sep 202531min

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

Phonak has introduced the Virto R Infinio, its first fully rechargeable custom in-the-ear hearing aid. Built on the Infinio platform, Virto R offers a deeply recessed, discreet fit while delivering th...

27 Aug 202523min

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

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

What if a cochlear implant could adapt and improve throughout a patient’s lifetime? Hearing health advocate and author Gael Hannan sits down with Brendan Murray, Vice President of CI Product Portfolio...

25 Aug 202523min

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 Aug 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...

19 Aug 202540min

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 Aug 202523min

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