FDA Approves OTC Sales of Hearing Aids

17 AUGUST 2022 - The U.S. Food and Drug Administration may have just handed Apple a new market. Engadget says the FDA has given the all-clear to over-the-counter sales of hearing aids. According to the report, the regulator

…has issued a final rule allowing the sales of hearing aids for mild-to-moderate impairment without requirements for exams, prescriptions or audiologist fittings.

The rule’s been a few years in the making. Congress actually passed laws “requiring over-the-counter hearing aids in 2017,” according to the report. That was meant to lower their cost, “improve access,” and foster competition. Now five-years-later, it’s a thing.

Will Apple jump in? Between their earbud acumen, the accessibility features already built into AirPods, and the company’s ever growing interest in health, it kind of seems a natch. Additionally, the Wall Street Journal (via Apple 3.0) ran a report in October of 2021 that had Apple looking at ways to add more health and wellness features to AirPods, including - no surprise - enhancing hearing. According to that report:

It isn’t clear if Apple is developing specific new hearing-aid features for AirPods or wants to market the earbuds’ existing hearing-improvement features as hearing aids. AirPods Pro, Apple’s higher-end earbuds, already offer features to improve hearing, including “conversation boost,” (…) that increases the volume and clarity of people in front of the wearer.

Also there’s money in it. The Engadget piece says a number of audio electronics makers already have hearing aids on the market ranging in price from $800 to $1,800. Sounds like a lot though it’s apparently not, compared to the thousands of dollars prescription hearing aids can cost. One could easily see Apple either offering redesigned AirPods Pro at a higher price for the hearing aid market, or redesigning AirPods Pro and offering them at today’s price to undercut the competition while operating at roughly the same profit margin.

Or they might not do hearing aids. That would be surprising, but we’ve all been surprised before.