It’s official: Apple has won U.S. Food and Drug Adminstration (FDA) clearance to market its AirPods Pro 2 wireless earbuds as OTC hearing aids. The evolution of these personal audio devices into full-fledged hearing aids could have big ramifications for the fledgling over-the-counter hearing aid market and people’s willingness to adopt these devices.
At its iPhone 16 launch event in September, Apple announced that its existing flagship wireless earbuds will get several new hearing health features later this fall.
Apple doesn’t report sales figures for its AirPods family of products. However, some estimates put the total number of units sold in 2023 at 75 million, with the AirPods Pro 2 accounting for up to 63% of those sales. In theory, this automatically makes the AirPods Pro 2 the most successful OTC hearing aids by a huge margin, though certainly not every pair will be used that way. Some estimates put the size of the U.S. OTC hearing aid market at under 200,000 units.
Use of the AirPods Pro 2 as hearing aids could be the tide that lifts all boats. As it becomes more common to see people leaving the iconic white earbuds in their ears in social settings, it’s likely that attitudes toward OTC hearing aids in general will start to shift.
The Hearing Loss Association of America (HLAA) believes Apple’s entry into the market is good news.
“We don’t advocate for one product over another,” HLAA director of strategic communications Meredith Resnick wrote in an email to Digital Trends. “But we think the announcement by Apple this week is exciting. This is really the kind of innovation we hoped the opening of the OTC hearing aid market would spur to give people more choices.”
Resnick notes that AirPods Pro 2’s popularity could also play a big role in the adoption of OTC hearing aids.
“It helps raise awareness that hearing is an important part of overall health and wellness, and should be protected, tested and treated if needed,” she wrote.
Apple’s traditional rivals in the wireless earbuds space, like Sony, Sennheiser, Jabra, and Bose, have been attempting to break into the OTC hearing aid category for several years. Each brand either makes dedicated OTC products or has partnered with third parties to bring technology to market. So far, none have used their existing personal audio products to do so, though with Apple’s announcement, that could change fast.
