Samsung’s Galaxy Buds can now legally function as over-the-counter hearing aids in the United States. The company announced that the U.S. Food and Drug Administration has cleared its Galaxy Buds Hearing Aid feature, which will roll out on the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in Q4 2026.
The clearance allows the earbuds to serve as hearing aids for adults 18 and older with mild to moderate hearing loss — no separate app or additional hardware required. Samsung is also introducing a built-in Hearing Test accessible through the Buds settings, which can assess a user’s hearing in roughly five minutes.
Galaxy Buds Hearing Aid: How It Works
Once the Hearing Test identifies a hearing deficit, the earbuds amplify sounds the wearer struggles to hear, including distant voices and high-frequency audio, tailored to an individual hearing profile. The entire system lives inside the Galaxy Buds software — there is nothing extra to download or pair.
Samsung says the feature was clinically validated through studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis. The company also collaborated with Australia’s National Acoustic Laboratories and Samsung Medical Center during development.
Catching Up to Apple
Samsung is not the first to win FDA clearance for earbuds-as-hearing-aids. Apple’s AirPods Pro 2 received their own FDA authorization in October 2024, making the hearing-aid function a live feature on Apple’s platform for nearly two years before Samsung’s version ships. The competitive gap matters: if you already own Galaxy Buds 3 Pro or plan to buy the Buds 4 Pro, the feature arrives at no extra cost, but Apple users have had a meaningful head start.
The World Health Organization estimates that approximately 1.5 billion people currently experience some degree of hearing loss, with projections reaching 2.5 billion by 2050. Cost, social stigma, and limited access to professional audiology remain barriers to hearing-aid adoption — earbuds that double as hearing devices could lower the entry point significantly, though the Galaxy Buds 4 Pro are themselves a premium purchase.
Availability
The Hearing Aid and Hearing Test features will arrive on Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the U.S. and select international markets starting Q4 2026. Samsung has not yet specified which additional countries will receive the feature at launch or whether older Galaxy Buds models will be supported.
