Overview
- Samsung said Tuesday that the U.S. Food and Drug Administration cleared a Hearing Aid feature that allows select Galaxy Buds to be used as over‑the‑counter hearing aids for adults 18 and older with perceived mild to moderate hearing loss.
- The system includes a five‑minute, self‑administered Hearing Test registered as Software as a Medical Device that produces a medical‑grade audiogram used to tune amplification per ear using the NAL‑NL2 clinical fitting formula.
- Hearing Aid adds hearing‑aid‑style processing such as noise elimination and directional beamforming, and test results plus noise‑exposure data sync to Samsung Health for ongoing tracking.
- Samsung plans a staged rollout in Q4 2026 for the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the United States and select approved markets and the feature requires a Galaxy phone running One UI 8 or later.
- The clearance expands low‑cost access to basic hearing support but has limits: it is not a substitute for audiologist diagnosis or treatment for severe or sudden loss, may be constrained by earbud battery life, and matches earlier moves by Apple to embed FDA‑cleared hearing tools in earbuds.