Samsung has announced that the Hearing Aid feature on select Galaxy Buds has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible earbuds to function as over-the-counter (OTC) hearing aids for adults with perceived mild to moderate hearing loss. The feature is designed for users aged 18 years and above and aims to improve access to hearing support without requiring a prescription or clinic visit. Samsung has also integrated a Hearing Test feature that provides medical-grade hearing assessments directly through the earbuds.
The newly approved Hearing Aid feature will be available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro. According to Samsung, users can complete a self-administered hearing test in around five minutes using clinical-grade pure-tone audiometry. The software evaluates each ear individually, generates an audiogram comparable to a professional hearing assessment, and classifies hearing ability into normal, mild, moderate, severe, or profound hearing loss categories.
Based on the hearing test results, the Hearing Aid feature automatically personalises audio amplification to match an individual's hearing profile. Samsung says the system can enhance sounds that are typically difficult to hear, including higher frequencies, distant voices, and quiet conversations. It also incorporates advanced technologies such as beamforming and noise elimination to improve speech clarity in noisy environments. The company adds that the feature uses the NAL-NL2 fitting formula, which is widely recognised as the clinical standard for prescription hearing aids.
Samsung noted that hearing loss remains one of the world's most common yet under-treated health conditions. Citing World Health Organization estimates, the company said more than 1.5 billion people globally currently experience some degree of hearing loss, with that figure expected to rise to 2.5 billion by 2050. The company says making hearing support available through widely used consumer devices could help address barriers such as cost, accessibility, and social stigma associated with traditional hearing aids.
The company also highlighted its continued investment in hearing health. Samsung introduced a Personal Sound Amplification Product (PSAP) feature on the Galaxy Buds+ in 2020, which was clinically validated in 2021. For the new OTC hearing aid solution, Samsung collaborated with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC), with additional clinical validation carried out by Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
In addition to hearing assistance, Samsung is integrating hearing-related insights into the Samsung Health app, allowing users to monitor Hearing Test results and noise exposure levels alongside other health metrics. Full functionality requires a compatible Galaxy smartphone running One UI 8 or later. Samsung says the Hearing Aid and Hearing Test features will roll out on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the U.S. and select approved markets during the fourth quarter of 2026.
Samsung's latest announcement reflects a broader trend of consumer electronics companies expanding into digital health. While hearing support has traditionally relied on dedicated medical devices, integrating FDA-cleared hearing assistance into mainstream wireless earbuds could make the technology more accessible to users who may not otherwise seek conventional hearing aids. The move also strengthens Samsung's growing health ecosystem by combining wearable hardware, software-based diagnostics, and Samsung Health into a more comprehensive wellness platform.
