The FDA clears Samsung Galaxy Buds to work as hearing aids

Samsung announced on 11 August 2026 that the FDA has cleared the Hearing Aid feature on Galaxy Buds3 Pro and Galaxy Buds4 Pro as an over-the-counter hearing aid for adults 18 and older with perceived mild to moderate hearing loss. No prescription and no clinic visit are required.

The clearance covers two linked pieces. The Galaxy Buds Hearing Test is registered as Software as a Medical Device and runs a five-minute self-administered audiogram; the Hearing Aid feature then amplifies sound frequency by frequency using NAL-NL2, the fitting formula clinical audiologists apply to prescription hearing aids. Samsung names the National Acoustic Laboratories, Samsung Medical Center, Vanderbilt University Medical Center, San Jose State University and the University of Memphis as collaborators.

What changes when a second phone maker enters this category is the size of the installed base. Hearing augmentation stops being a dedicated device someone has to decide to buy, and becomes a setting inside earbuds already in a pocket — bought for music, then reconfigured by a test the owner takes themselves.

The features ship in Q4 2026 in the United States and select approved markets. Samsung announced no pricing, and the clearance covers only these two earbud models.