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(351)

Technology Spotlight: QuietTV Wireless Headset. Interview with Sandra Porps, AuD

Technology Spotlight: QuietTV Wireless Headset. Interview with Sandra Porps, AuD

In this week's technology spotlight. Dr. Bob Traynor speaks with Sandra Porps, Au.D., Head of Audiology for MDHearing. The pair discuss the company's new QuietTV wireless headset - a device designed t...

5 Marras 202111min

019 - OTC Hearing Aids & Self-Fit Technologies: Interview with Intricon's Delain Wright

019 - OTC Hearing Aids & Self-Fit Technologies: Interview with Intricon's Delain Wright

In this week's episode, Dave Kemp interviews Delain Wright of Intricon - a company that has been a supplier to the hearing aid industry for decades. In recent years, Intricon has shifted focus to t...

3 Marras 202145min

018 - Using Non-Custom Amplifiers and Telehealth in Audiology Clinical Practice

018 - Using Non-Custom Amplifiers and Telehealth in Audiology Clinical Practice

The practice of audiology is rapidly changing. It’s simply not enough to passively wait in your clinic for patients to show up looking for help; audiologists must become actively involved in providing...

2 Marras 202124min

017 - Wax Removal with Push of a Button: Interview with Sahil Diwan and Jackie Phillips of Safkan Health

017 - Wax Removal with Push of a Button: Interview with Sahil Diwan and Jackie Phillips of Safkan Health

Cerumen, better known as earwax, is one reason that hearing aids breakdown and a hinderance to the service delivery model as some providers refer patients to other professionals for cerumen removal. ...

28 Loka 202141min

016 - Addressing the Hearing in Noise Problem: Interview with Dr. Tim Trine, CEO of Noopl

016 - Addressing the Hearing in Noise Problem: Interview with Dr. Tim Trine, CEO of Noopl

In this week's episode, Dave Kemp interviews Dr. Tim Trine, CEO of Noopl. His company was recently named 'Innovator of the Year' by an international panel of judges in the 2021 Hearing Technology Inno...

25 Loka 202130min

015 - OTC Hearing Aids and Legislative Changes in Hearing Healthcare: Interview with Brandon Sawalich, President & CEO of Starkey

015 - OTC Hearing Aids and Legislative Changes in Hearing Healthcare: Interview with Brandon Sawalich, President & CEO of Starkey

Brandon Sawalich, President and CEO of Starkey, sat down with Dr. Bob Traynor to discuss OTC hearing aids and other legislative initiatives impacting the hearing healthcare industry. They discuss th...

20 Loka 202123min

014 - Implantable Hearing Devices: What Clinicians Need to Know. Interview with George Cire, AuD

014 - Implantable Hearing Devices: What Clinicians Need to Know. Interview with George Cire, AuD

George Cire is a true industry veteran with more than 40 years of experience, much of it involving implantable hearing devices. During his conversation with Brian Taylor, George reviews the three type...

19 Loka 202135min

013 - Hearing Aid Fitting: The Value of Customized Gain and Output Measures - Interview with Lindsey Jorgensen, AuD, PhD

013 - Hearing Aid Fitting: The Value of Customized Gain and Output Measures - Interview with Lindsey Jorgensen, AuD, PhD

Lindsey Jorgensen, AuD, PhD is a department chair, clinical director and assistant professor at the University of South Dakota. She sat down with Brian Taylor to discuss the tried and true prescriptiv...

12 Loka 202140min

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