Overview
- Samsung confirmed on Aug. 11, 2026 that the U.S. Food and Drug Administration cleared a Hearing Aid feature that allows compatible Galaxy Buds to function as an over‑the‑counter hearing aid for adults with perceived mild to moderate hearing loss.
- The Buds will run a built‑in five‑minute pure‑tone audiometry Hearing Test registered as Software as a Medical Device that generates a medical‑grade audiogram used to personalize amplification.
- The Hearing Aid uses clinical fitting (NAL‑NL2), noise elimination, and beamforming directional microphones to boost frequencies a user struggles with, such as high pitches and distant voices.
- Samsung says the features are backed by validation studies and development partnerships including the National Acoustic Laboratories, Samsung Medical Center, Vanderbilt, San Jose State and the University of Memphis.
- The Hearing Test and Hearing Aid will roll out in Q4 2026 on Galaxy Buds 3 Pro and Buds 4 Pro in the U.S. and select markets, require a Galaxy device with One UI 8 or later, and are intended as an accessible option not a replacement for clinical care.