Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA

August 12, 2026

Samsung Electronics today announced that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy Buds1 to serve as an over-the-counter (OTC) hearing aid,2 offering users 18 years and older a convenient solution for addressing perceived mild to moderate hearing loss — which may be indicated by difficulty following conversations in noisy environments — without a prescription or clinic visit. Users can also diagnose their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.

For more information, please see:
https://news.samsung.com/global/samsungs-hearing-aid-feature-on-galaxy-buds-cleared-by-fda