Nearly half a decade after Congress passed a law requiring the FDA to create a new regulatory category specifically for hearing aids sold over-the-counter, the wheels are finally moving with the comment period for the proposed ruling recently closed.
In the meantime, however, hearing device makers haven’t been resting on their laurels. Bose began rolling out its self-fitting hearing aids last spring, and at the end of this month, GN Audio's Jabra brand will begin rolling out its own sound-enhancing earbuds.
The Enhance Plus earbuds have been cleared by the FDA as self-fitting hearing aids. Beginning Feb. 25, they’ll be available for purchase through hearing care providers around the U.S. They’ll retail for $799—about $50 less than Bose’s devices and significantly lower than other hearing aid makers’ prices—though the cost may go up depending on whether a given state requires hearing tests or other services prior to hearing aid distribution.
(Jabra)
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That middleman could be cut out and the earbuds sold directly to consumers when the FDA finalizes its regulations on over-the-counter hearing aids. The 2017 congressional action asked the agency to separate those devices into a category of their own, allowing them to be sold without prescriptions or state-level oversight, therefore lowering costs.
Last October, urged on by an executive order from President Joe Biden, the FDA made good on the 2017 act. It proposed new regulations for hearing aids marketed directly to consumers who have mild to moderate hearing loss and are over the age of 18, a group that the agency estimated comprises about 15% of American adults.
The comment period on the proposed rule ended Jan. 18, so the arrival of the finalized rule is likely imminent.
Depending on the terms of the final rule, Jabra could begin selling its devices straight to consumers, rather than through hearing clinics. Bose, meanwhile, could list its SoundControl hearing aids explicitly as over-the-counter devices, a label it’s currently not able to use, even though the devices are cleared by the FDA and available for online purchase in every U.S. state.
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The Jabra Enhance Plus earbuds are not only designed to enhance hearing during conversations, but can also be used to listen to music and take phone calls. They connect to a wearer’s iPhone, where the Jabra Enhance app can be used to adjust the sound quality and volume of the hearing aids.
Jabra claims that the miniaturized devices are 40% smaller than its wireless Elite 7 Pro earbuds, and that they last 10 hours on a single charge in the included charging case.
“When the new OTC regulation comes into effect, we look forward to be there to help people with solutions that provide better situational hearing as well as music and calls in modern and stylish designs,” said Jabra CEO René Svendsen-Tune.