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)

318 - Understanding Hearing Loss Stigma — What New Research Reveals

318 - Understanding Hearing Loss Stigma — What New Research Reveals

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317 - Phonak Infinio Ultra Hearing Aids Combine AI Sound and Easy Maintenance

317 - Phonak Infinio Ultra Hearing Aids Combine AI Sound and Easy Maintenance

At EUHA 2025, Phonak presented the latest advancements to its Infinio platform, including the Virto R Infinio custom rechargeable hearing aid and the new Infinio Sphere Ultra upgrade. In a discussion ...

6 Nov 202524min

316 - Oticon Zeal Hearing Aids Bring AI Sound Processing to a Compact In-the-Ear Design

316 - Oticon Zeal Hearing Aids Bring AI Sound Processing to a Compact In-the-Ear Design

At EUHA 2025, Oticon introduced its newest in-the-ear hearing aid, Oticon Zeal, bringing the company’s second-generation AI sound processing and BrainHearing™ technology to a smaller, ready-to-fit for...

5 Nov 202512min

315 - Exploring Starkey’s Omega AI Hearing Aids: A Conversation with CTO Achin Bhowmik

315 - Exploring Starkey’s Omega AI Hearing Aids: A Conversation with CTO Achin Bhowmik

Earlier this month, Starkey released its Omega AI hearing aid platform, and at EUHA 2025, Chief Technology Officer Achin Bhowmik discussed how the company’s latest generation builds on prior AI-driven...

31 Okt 202525min

314 - Aaron Small and Robin Gillon Talk Hearing Loss, Confidence, and the Power of Connection

314 - Aaron Small and Robin Gillon Talk Hearing Loss, Confidence, and the Power of Connection

Andrew Bellavia joined Phonak ambassadors — Olympian Aaron Small and pro skier Robin Gillon — on stage to share honest conversations about hearing loss, stigma, and the role technology plays in stayin...

30 Okt 202516min

313 - Rethinking Preschool Hearing Screening: An Evidence-Based Approach with Dr. James W. Hall

313 - Rethinking Preschool Hearing Screening: An Evidence-Based Approach with Dr. James W. Hall

Early detection of hearing loss shouldn’t stop at birth. In this episode, Dr. Bob Traynor speaks with Dr. James W. Hall III, an internationally recognized audiologist, educator, and author with more t...

24 Okt 202528min

312 - Inside Audien’s Atom X Hearing Aids: CEO Ishan Patel Talks Innovation and Accessibility

312 - Inside Audien’s Atom X Hearing Aids: CEO Ishan Patel Talks Innovation and Accessibility

With the Atom X, Audien introduces a new touchscreen-based hearing aid designed for simplicity and accessibility. Andy Bellavia speaks with Audien Hearing CEO Ishan Patel about the device’s key featur...

23 Okt 202536min

311 - Advocating for the Medicare Audiology Access Improvement Act | ADA Lobby Day 2025

311 - Advocating for the Medicare Audiology Access Improvement Act | ADA Lobby Day 2025

Audiologists took to Capitol Hill on Thursday, September 25, 2025, to advocate for better patient access to hearing and balance care as part of ADA Lobby Day in Washington, D.C.Held during the Academy...

20 Okt 20258min

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