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)

280 - Improving Access to Cochlear Implants: A Surgeon’s Perspective

280 - Improving Access to Cochlear Implants: A Surgeon’s Perspective

Cochlear implants remain vastly underutilized despite decades of evidence showing their ability to restore hearing and improve quality of life. In this episode, neurotologist Dr. Varun Varadarajan joi...

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279 - Cochlear Implants from Consultation to Activation: Navigating the CI Surgeon-Hearing Care Provider Relationship

279 - Cochlear Implants from Consultation to Activation: Navigating the CI Surgeon-Hearing Care Provider Relationship

From first consult to post-activation, cochlear implant success often depends on the strength of the care team behind the patient. In this episode, Dr. Kevin Zhan, Assistant Professor of Otolaryngolog...

29 Apr 202529min

278 - OTC Hearing Glasses Hit the U.S. Market: Inside the Nuance Audio Launch

278 - OTC Hearing Glasses Hit the U.S. Market: Inside the Nuance Audio Launch

Nuance Audio has officially introduced its over-the-counter (OTC) hearing aid glasses to the U.S. market. In this episode, recorded at the launch event in New York, Andrew Bellavia speaks with Davide ...

22 Apr 202516min

277 - Partnering with Primary Care: How QuickTest Supports Hearing Practice Growth

277 - Partnering with Primary Care: How QuickTest Supports Hearing Practice Growth

How can hearing care professionals expand their reach by partnering with primary care? This week, Dr. Angela Morris, audiologist and Account Manager at Shoebox, discusses innovative approaches to inte...

21 Apr 202528min

276 - Hearing Aid Fittings Get Smarter: NAL Introduces NAL-NL3 and COSI 2.0

276 - Hearing Aid Fittings Get Smarter: NAL Introduces NAL-NL3 and COSI 2.0

Can hearing aids be personalized for specific environments or even people with no measurable hearing loss? In this episode, recorded at the National Acoustic Laboratories (NAL), host Andrew Bellavia s...

17 Apr 202550min

275 - Inside Regeneron’s Groundbreaking Hearing Loss Gene Therapy Treatment Program

275 - Inside Regeneron’s Groundbreaking Hearing Loss Gene Therapy Treatment Program

Gene therapy is rapidly emerging as a transformative approach for treating genetic hearing loss, with Regeneron advancing one of the field’s most promising candidates: DB-OTO. In this conversation, Re...

9 Apr 202548min

274 - Pathways Symposium on CAPD: Bridging Science and Clinical Practice in Neuroaudiology

274 - Pathways Symposium on CAPD: Bridging Science and Clinical Practice in Neuroaudiology

In this week’s episode, host Bob Traynor is joined by Dr. Frank Musiek to discuss the upcoming second annual "Pathways: Quest for the Best in CAPD and Neuroaudiology." This virtual symposium, set to t...

8 Apr 202521min

273 - How 'HearO Saves the Day' Helps Children Learn About Safe Listening Habits

273 - How 'HearO Saves the Day' Helps Children Learn About Safe Listening Habits

Noise-induced hearing loss is on the rise among children, often due to prolonged exposure to loud music and environments without proper hearing protection. In this episode, Dr. Sherilyn Adler, Executi...

7 Apr 202526min

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