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

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326 - Can Auracast Redefine Audio Accessibility in Public Spaces?

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325 - Giants of Audiology: Interview with Richard W. Danielson, PhD

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17 Dec 202533min

323 - How Hearing Aid Innovation Happens: Jason Galster on Turning Research Into Real-World Technology

323 - How Hearing Aid Innovation Happens: Jason Galster on Turning Research Into Real-World Technology

Where do the best ideas in hearing aid innovation come from, and how do they reach patients? In this conversation, Dr. Jason Galster, Vice President of Clinical Research at Sonova, explains how hearin...

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322 - Widex Allure Expands With BTE, Rechargeable ITE, Portable Charging & Software Updates

322 - Widex Allure Expands With BTE, Rechargeable ITE, Portable Charging & Software Updates

Widex has expanded its Allure™ hearing aid platform with new form factors and charging options, giving hearing care professionals more flexibility across a wider range of patient needs. In this discus...

9 Dec 202528min

321 - Life With a Fully Implanted Cochlear Implant: Michael Seufer Shares His Experience

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A fully implantable cochlear implant isn’t just a technical milestone—it's a fundamentally different way of living with hearing loss. In a candid conversation, Gael Hannan speaks with Michael Seufer, ...

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320 - Exploring the H1 Hearing Buds: LXE’s Entry Into Earbud-Style OTC Hearing Aids

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A growing number of people are exploring hearing help earlier, and LXE Hearing believes there is a place for devices that bridge the gap between everyday earbuds and traditional hearing aids. In a det...

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