Samsung Galaxy Buds FDA Hearing Aid Clearance

Samsung Electronics received U.S. United States — Food and Drug Administration (FDA) clearance for a Hearing Aid feature on its Galaxy Buds wireless earbuds, allowing them to function as over-the-counter (OTC) hearing aids for adults aged 18 and above with perceived mild to moderate hearing loss. The feature, launching in Q4 2026 on Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the U.S. and select approved markets, includes a built-in five-minute Hearing Test using pure-tone audiometry to generate a medical-grade audiogram. The Hearing Aid feature then uses these results to amplify specific frequencies, with additional noise elimination and beamforming capabilities. Samsung developed the technology with the Australia — National Acoustic Laboratories and Samsung Medical Center, and clinical studies were conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis. The system uses the NAL-NL2 fitting formula, a recognized clinical standard. This clearance follows Apple Inc.'s introduction of FDA-cleared hearing aid functionality for AirPods Pro 2 in 2024, positioning Samsung as a direct competitor in the consumer hearing health space. The World Health Organization estimates that over 1.5 billion people worldwide have hearing loss, a figure projected to rise to 2.5 billion by 2050, highlighting the potential market for accessible hearing solutions.