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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041 - Inclusive Communication and Services for Diverse Communities: Interview with Dr. Alejandra Ullauri

041 - Inclusive Communication and Services for Diverse Communities: Interview with Dr. Alejandra Ullauri

As the U.S. population becomes more diverse, it is imperative for hearing care professionals to provide patient centered care to everyone. Many clinicians around the country, however, lack the necessa...

22 Helmi 202232min

040 - Redesigning Hearing Aids from Scratch: Interview with Nick Morgan-Jones and Gray Dawdy of Decibels

040 - Redesigning Hearing Aids from Scratch: Interview with Nick Morgan-Jones and Gray Dawdy of Decibels

This week, host Dave Kemp is joined by Nick Morgan-Jones and Gray Dawdy of Decibels. Nick has needed hearing aids since the age of 10, but was turned off by the stigma associated with traditional he...

16 Helmi 202239min

039 - Incorporating Tinnitus Management into Clinical Practice: Interview with Jodi Sasaki-Miraglia, AuD, of Widex

039 - Incorporating Tinnitus Management into Clinical Practice: Interview with Jodi Sasaki-Miraglia, AuD, of Widex

This week, host Dave Kemp is joined by Jodi Sasaki-Miraglia, AuD, Director of Education & Training-West Region for Widex USA. The pair discuss the benefits of adding tinnitus evaluation and managem...

15 Helmi 202232min

038 - Fluid In the Ear? New Imaging Technology Aims to Revolutionize Middle Ear Assessment

038 - Fluid In the Ear? New Imaging Technology Aims to Revolutionize Middle Ear Assessment

Young children are prone to middle ear infections. New technology is empowering front-line professionals to increase their sensitivity in identifying fluid in the middle ear. Photonicare has developed...

8 Helmi 202238min

037 - Using Haptic Tech to Address Hearing Loss & Tinnitus: Interview with Dr. David Eagleman

037 - Using Haptic Tech to Address Hearing Loss & Tinnitus: Interview with Dr. David Eagleman

Who would have ever thought the human brain would be compared to Mr Potato Head? With its phenomenal capacity to change and re-wire itself at any age, our guest this week, the incomparable neuroscient...

2 Helmi 202216min

036 - Remote Hearing Care Services: Meeting Consumers Where They Are

036 - Remote Hearing Care Services: Meeting Consumers Where They Are

The manner in which hearing care is delivered is changing. At the forefront of this change is Tuned, an online virtual platform that empowers both the provider and the patient to strive towards improv...

1 Helmi 202241min

035 - FX-322 Hearing Loss Treatment: Clinical Trial Data Shows Promise in Hair Cell Regeneration

035 - FX-322 Hearing Loss Treatment: Clinical Trial Data Shows Promise in Hair Cell Regeneration

The ability of human cochlear hair cells to regenerate has been nothing more than a pipe dream – until recently. Frequency Therapeutics, a publicly traded (NASDAQ) company based in Lexington, Massachu...

25 Tammi 202231min

034 - Cheers to 50 Years! Celebrating 50 Years of Hearing Aid Fitting with Dr. Gus Mueller

034 - Cheers to 50 Years! Celebrating 50 Years of Hearing Aid Fitting with Dr. Gus Mueller

This Week in Hearing co-host, Bob Traynor, is joined by special guest, Dr. Gus Mueller, to celebrate 50 years since his first hearing aid fitting as an audiologist in the US Army stationed at Walter R...

21 Tammi 202240min

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