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(351)

026 - Early Identification of Hearing Loss in Adults and the Limitations of the Audiogram

026 - Early Identification of Hearing Loss in Adults and the Limitations of the Audiogram

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The Round Table: Exploring Key Insights on the Changing Hearing Health Landscape

The Round Table: Exploring Key Insights on the Changing Hearing Health Landscape

This Week in Hearing co-hosts, Dave Kemp, Bob Traynor, Amyn Amlani, and Brian Taylor, reflect on insights they've gained and key takeaways they've learned from more than 25 interviews with industry ex...

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025 - Role of the Audiologist in Cognitive Screening: Physician Perspective

025 - Role of the Audiologist in Cognitive Screening: Physician Perspective

This special edition of This Week in Hearing is a candid discussion on the health care landscape, as provided by two accomplished and distinguished physicians: Dr. Ardeshir Z. Hashmi, Endowed Chair of...

7 Des 202150min

024 - Understanding the Relationship between Cognitive Decline and Hearing Loss: ADA Panel Session

024 - Understanding the Relationship between Cognitive Decline and Hearing Loss: ADA Panel Session

The role of cognitive screenings in audiology practice has been and continues to be a topic of discussion. In this special edition of This Week in Hearing, HHTM is partnering with the Academy of Docto...

30 Nov 20211h 29min

023 - Digital Therapeutics in Hearing Healthcare: Interview with Nancy Tye Murray and Chris Cardinal of Amptify

023 - Digital Therapeutics in Hearing Healthcare: Interview with Nancy Tye Murray and Chris Cardinal of Amptify

The benefits of aural rehabilitation (AR) for people with hearing loss has been well established for decades. Yet, for a variety of reasons, very few people diagnosed with hearing loss today receive a...

23 Nov 202131min

022 - Democratizing Access to Better Hearing: Interview with Sarah Voice of Mimi Hearing Technologies

022 - Democratizing Access to Better Hearing: Interview with Sarah Voice of Mimi Hearing Technologies

Ever wish you could fine-tune the frequency response of your favorite electronic devices? Well, Mimi Hearing Technologies allows you to do this in products that license their software development tool...

16 Nov 202119min

021 - Dr. Tom Tedeschi Breaks Down FDA's Proposed OTC Hearing Aid Regulations + ADA Panel Discussion

021 - Dr. Tom Tedeschi Breaks Down FDA's Proposed OTC Hearing Aid Regulations + ADA Panel Discussion

In this special edition of This Week in Hearing, Dr. Tom Tedeschi breaks down the FDA's draft proposal for Over The Counter (OTC) hearing aids. The presentation and subsequent panel discussion was par...

10 Nov 202148min

020 - New Medicare Hearing Benefit and FDA's Proposed OTC Hearing Aid Regulations - Industry Perspective with Brandon Sawalich

020 - New Medicare Hearing Benefit and FDA's Proposed OTC Hearing Aid Regulations - Industry Perspective with Brandon Sawalich

Brandon Sawalich, President and CEO of Starkey, returns to discuss the recently released FDA proposed rule for Over The Counter (OTC) hearing aids, as well as the new Medicare Hearing Benefit currentl...

8 Nov 202126min

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