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Samsung received FDA clearance for a hearing aid feature on its Galaxy Buds on August 11th. The clearance allows compatible Galaxy Buds to function as an over-the-counter hearing aid for adults 18 and older with mild to moderate hearing loss, without a prescription or clinic visit.
The feature works on the Galaxy Buds3 Pro and Galaxy Buds4 Pro and requires a compatible Galaxy smartphone. According to Samsung, users take a self-administered hearing test built into the earbud settings, which uses pure-tone audiometry to test each ear separately and generates an audiogram. The hearing aid feature then amplifies sounds the user has difficulty hearing, personalized to their hearing profile using the NAL-NL2 fitting formula, a clinical standard. Samsung claims the earbuds also support noise reduction and beamforming, which focuses on sound coming from in front of the wearer.
Samsung joins Apple in offering over-the-counter hearing aid functionality through consumer earbuds. Apple received FDA clearance for a similar AirPods Pro feature in 2024. The OTC hearing aid category was established by the FDA in 2022 for adults with mild to moderate hearing loss.
The feature is scheduled to become available in the United States and select other approved markets in the fourth quarter of 2026. As with other OTC options, these devices are intended for perceived mild to moderate hearing loss and are not a substitute for a professional evaluation for people whose hearing needs may be more significant.
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