Meta will add FDA-cleared hearing aid software to supported AI glasses in the U.S. later this year, the company said at its recent Meta Connect 2026 event.
The feature, called Hearing Enhancement, is intended for adults 18 and older with perceived mild-to-moderate hearing loss, per a Sept. 23 blog post. Users can set it up at home in minutes without a clinic visit or prescription. It will cost $149.99 as an add-on, which is eligible for health savings account and flexible spending account reimbursement, or be included with a Meta One subscription.
The FDA cleared the underlying software, called Hearing Assist, on July 13 as an over-the-counter, self-fitting hearing aid, according to agency clearance documents. Meta named Apple’s Hearing Aid Feature for AirPods Pro 2 as its predicate device. Unlike AirPods, the glasses deliver amplified sound without blocking the ear canal.
Meta supported its submission with a clinical study of 142 adults at three U.S. sites. Participants who set up the software themselves met the study’s noninferiority criteria compared with those whose devices were fitted by a licensed hearing care professional, on both the primary and secondary endpoints. Users also saw an average 4.8-decibel signal-to-noise benefit in speech-in-noise testing.
Five participants reported six mild, temporary device-related side effects, most commonly headache. The study recorded no serious adverse device effects.
Meta’s clearance also covers a plan to add an Android version of the companion smartphone app, which currently runs only on iOS.
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