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)

005 - Leveraging AI for Next-Generation Hearing Enhancement: Knowles and Chatable Partnership

005 - Leveraging AI for Next-Generation Hearing Enhancement: Knowles and Chatable Partnership

In recent surveys, up to 60% of hearables users said they would find conversational enhancement desirable. Such large percentages mean people who do not measure as having hearing loss also wish to hea...

16 Elo 202127min

004 - Understanding Your Value & Leveraging Collaborative Negotiation in the Audiology Workplace - Kaila Howard, AuD, Riley DeBacker, AuD & PhD, Ashley Hughes, AuD

004 - Understanding Your Value & Leveraging Collaborative Negotiation in the Audiology Workplace - Kaila Howard, AuD, Riley DeBacker, AuD & PhD, Ashley Hughes, AuD

Guests: Kaila Howard, AuD & Riley DeBacker, AuD PhD Host: Ashley Hughes, AuD In this week's segment of This Week in Hearing, host Ashley Hughes, AuD, chats with Kaila Howard, AuD, and Riley DeBacker,...

10 Elo 202128min

003 - Hearing Aid Delivery: Leasing and Subscription Models - Jim Kothe, Dan Quall and Bob Traynor

003 - Hearing Aid Delivery: Leasing and Subscription Models - Jim Kothe, Dan Quall and Bob Traynor

Guests: Jim Kothe, Head of Sales for Whisper Hearing; Dan Quall, Director of Strategic Initiatives for Fuel Medical Moderator: Dr. Bob Traynor, Consultant and Professor of Audiology Dr. Bob Traynor in...

3 Elo 202143min

002 - Medicare Audiologist Access and Services Act (MAASA): How Would it Impact Professionals and Patients? - Alicia Spoor, AuD & Amyn Amlani, PhD

002 - Medicare Audiologist Access and Services Act (MAASA): How Would it Impact Professionals and Patients? - Alicia Spoor, AuD & Amyn Amlani, PhD

Guest: Alicia Spoor - Audiologist & Owner of Designer Audiology Moderator: Amyn Amlani - Audiology Professor and Consultant at Otolithic Consulting The Medicare Audiologist Access and Services Act (MA...

28 Heinä 202122min

001 - The Impact of Consumer Audio on Hearing Hearing Healthcare - Brent Edwards, Andy Bellavia & Dave Kemp

001 - The Impact of Consumer Audio on Hearing Hearing Healthcare - Brent Edwards, Andy Bellavia & Dave Kemp

Guests: Brent Edwards, Director of the National Acoustics Lab; Andy Bellavia, Director of Business Development at Knowles Corp Moderator: Dave Kemp, Director of Business Development at Oaktree Product...

28 Heinä 202129min

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