The FDA has cleared Samsung's Galaxy Buds to work as over-the-counter hearing aids. Adults 18 and older with self-perceived mild to moderate hearing loss can use them without a prescription, a clinic visit or any separate hardware. The whole thing lives in the Galaxy Buds settings menu on a paired phone rather than a standalone app, and a five-minute pure-tone test builds the profile it tunes to.
That test is registered as a Software as a Medical Device and produces an audiogram, the standard chart of what each ear can hear, grading it from normal through mild, moderate, severe and profound loss. Playback then amplifies the frequencies a listener struggles with, quiet whispers and distant chatter among them, tuned by NAL-NL2, a globally recognized clinical fitting formula. Samsung built the feature with the National Acoustic Laboratories and Samsung Medical Center, and validation studies ran at Vanderbilt University Medical Center, San Jose State University and the University of Memphis. Samsung started down this road in 2020, with personal sound amplification on the Galaxy Buds+. The Hearing Test and Hearing Aid features reach the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the United States and select other markets in Q4 2026.