Samsung’s Galaxy Buds Hearing Aid feature has received US Food and Drug Administration clearance, allowing compatible earbuds to function as self-fitting over-the-counter hearing aids for adults 18 and older with perceived mild-to-moderate hearing loss. Samsung plans to begin rolling out the feature in the fourth quarter of 2026.
At launch, the feature will support the Galaxy Buds3 Pro and Galaxy Buds4 Pro and require a compatible Galaxy device running One UI 8 or later. The clearance adds a regulated medical function to Samsung’s consumer earbud lineup, following Apple’s move into OTC hearing-aid software in 2024.
FDA clearance gives Galaxy Buds a medical role
The FDA’s OTC hearing-aid category, which took effect Oct. 17, 2022, covers adults 18 and older with perceived mild-to-moderate hearing loss. Eligible devices can be bought without a medical exam, prescription, or fitting by an audiologist.
Samsung’s five-minute Hearing Test uses pure-tone audiometry to assess each ear and generate an audiogram. The Hearing Aid feature then uses that profile to tailor amplification, while noise reduction and beamforming are designed to improve speech intelligibility in noisy environments.
Hearing-test results and noise-exposure information can be viewed in Samsung Health, which is also adding AI-powered guidance for wearable data. The Hearing Aid and Hearing Test features are expected to reach the US and other approved markets in Q4 2026, but Samsung has not announced a specific launch date or named the additional markets.
OTC hearing aids are not intended for severe or profound hearing loss. FDA guidance advises people who suspect more significant hearing loss to seek professional care because OTC devices may not provide adequate benefit.
Samsung expands its regulated health footprint
Samsung now joins Apple in bringing regulated hearing-aid software to mainstream wireless earbuds. In September 2024, the FDA authorized Apple’s Hearing Aid Feature for compatible AirPods Pro models and described it as the first OTC hearing-aid software device.
Samsung has been developing hearing-assistance features for years. A 2021 Samsung Medical Center study found that the Galaxy Buds Pro’s Ambient Sound feature could help people with mild-to-moderate hearing loss hear surrounding sounds more effectively.
The move comes as Samsung expands health functions across its wearable ecosystem. Galaxy Watch 9 adds health features that also reach some earlier hardware, while Samsung is removing Vascular Load from US Galaxy Watches after offering it as an experimental wellness feature.
For organizations that support employee-owned or managed Galaxy devices, regulated health functions arriving through software add another device-governance consideration. Compatibility, regional availability, support policies, and the distinction between wellness features and cleared medical functions can affect how organizations evaluate wearable technology.
The initial hearing-aid rollout remains limited to two Buds models and approved markets. After launch, independent testing should show how Samsung’s implementation performs in everyday settings and whether support expands to more devices and regions.
Read more: Samsung is also pursuing more ambitious wearable-health capabilities, including work toward direct blood sugar tracking, where technical validation and regulatory clearance remain major hurdles.