With less than a week to go until the FDA’s long-awaited rule takes effect enabling hearing aids to be sold over the counter, consumer tech makers are lifting the curtain on their first entries in the brand-new medical device category.
Tech giant Sony as well as Lexie Hearing—which took over Bose’s direct-to-consumer hearing aid division earlier this year—unveiled new models of their self-fitting hearing aids this week.
Consumers will be able to buy those and other eligible devices in stores and online, no prescription or medical exam needed, once the FDA rule takes effect Oct. 17. Finalized in mid-August, it established a new category of devices aimed at making hearing aids more affordable and easily accessible to the approximately 30 million U.S. adults who could benefit from them. Currently, according to the FDA, only about 20% of that group uses the devices, which are priced on average between $1,000 and $4,000.
The rule covers only air-conduction hearing aids—which are worn in or behind the ear and don’t require a surgical implant—and applies to adults with mild to moderate hearing impairment, while those with severe hearing loss or under the age of 18 will continue to require a prescription.
Sony’s CRE-C10 and CRE-E10 earbudlike devices, which the tech giant debuted Wednesday, mark its first foray into the hearing health market and the first products of a partnership with hearing aid maker WS Audiology that was announced last month.
The CRE-C10 hearing aids, priced at $1,000, run on standard size 10 batteries—six of which are included with the initial order—giving the devices a battery life of up to 70 hours of continuous use, per Sony. They’ll be available for purchase via Sony’s website and retailers like Amazon and Best Buy beginning this month.
The CRE-E10 model, meanwhile, runs on rechargeable batteries that boast 26 hours of continuous use per charge. It’s equipped with Bluetooth technology, allowing users to stream audio from their iOS devices through their hearing aids. Those upgraded features, of course, carry an upgraded price: $1,300 for the pair and their wireless charging case, which will go on sale later this winter.
Both of Sony’s OTC hearing aids connect to its Hearing Control app, where users can set up the devices and adjust the fit and volume levels. They can also continue to visit the app as needed to adjust volume and other settings based on different environments and other changes in their hearing needs; both models are designed to automatically adjust based on a user’s surroundings.
Lexie’s B2 hearing aids—which carry the “Powered by Bose” label—are similar to Sony’s upgraded CRE-E10 model. The devices are equipped with a rechargeable battery that lasts up to 18 hours after each three-hour charge. Lexie’s offerings, too, can be self-adjusted using the paired Lexie app, where users can tweak treble and bass frequencies and switch other settings based on changes in their environment.
The receiver-in-canal hearing aids are priced quite a bit lower than Sony’s own rechargeable option—at $999—and will be available for purchase in more than 11,000 pharmacy and retail locations, both online and brick-and-mortar, as soon as next week, the devicemaker announced Tuesday.
The handoff of Bose’s hearing device business to Lexie earlier this year came amid the total elimination of Bose’s consumer healthcare division in March, marking a sputtering end to Bose’s once-lauded expansion into health tech.
That short-lived exploration peaked in 2018 with FDA clearance for its SoundControl hearing aids, but it was all downhill from there: They didn’t officially launch in the U.S. until mid-2021—with the rollout further hampered by the lack of a definitive over-the-counter FDA ruling—and were discontinued just a year later amid the Lexie handoff.