The FDA has proposed the creation of a whole new category of hearing aids that can be purchased without providing a medical exam or having them fitted by an audiologist. Over-the-counter hearing aids seek to be an affordable barrier-free alternative online and in stores to the high-cost technology inaccessible for millions of Americans, increasing competition among producers along the way. Currently, only an approximated 14% of Americans with hearing loss can access prescription hearing aids, which can cost more than $5,000 a pair.
Supposedly, consumer electronics manufacturers will be able to enter the market that was so far dominated by a handful of companies like Sonova or ReSound. In July, the top hearing aid companies controlled 84% of the market. Apple is early to rise, as they are said to be working on a medical version of AirPods. Hearing aids for mild hearing loss have reached a market penetration of not more than 10%, which shows the potential for companies to innovate in this area. Aids of the description category will not be changed in their classification, however.
FDA will accept public comment on its proposal for 90 days and the regulation would become effective 60 days after publication of the final rule.
The Med-Tech World conference, which follows a successful digital event in 2020, will run from 18th-19th November 2021 and will highlight innovations and developments in digital health across the globe. With so many countries realising the potential for exponential growth, Med-Tech World will address the opportunities and challenges driving this multi-million forum – embracing the potential for technological innovation to change the face of medicine in this global sector. Register your interest here!