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: