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Samsung has introduced a new feature for its Galaxy Buds that allows them to double as over-the-counter hearing aids for adults with mild to moderate hearing loss, as approved by the US Food and Drug Administration. The feature, available for users aged 18 and above, does not require a prescription or clinic visit. Samsung claims the technology can assist those who struggle to follow conversations in noisy environments, providing basic hearing support through a device they may already own.

The FDA clearance marks a significant shift for Samsung from merely enhancing audio to entering a regulated hearing-support category. The feature comprises two parts: a Hearing Test and a Hearing Aid. The Hearing Test, registered as Software as a Medical Device (SaMD), conducts pure-tone audiometry to assess hearing in each ear separately, generating an audiogram and classifying hearing loss into four stages: mild, moderate, severe, and profound.

The Hearing Aid feature then personalizes amplification based on these results, rather than simply amplifying all sounds. It targets specific sounds users have difficulty hearing, such as higher frequencies, distant voices, and quieter speech. The system incorporates noise elimination and beamforming to reduce background noise and focus on sounds in front of the user.

Samsung's Hearing Aid system utilizes NAL-NL2, a clinical standard for fitting prescription hearing aids, to tailor the experience according to each user's hearing profile. This move aligns with Samsung's broader goal of making hearing support more accessible, with over 1.5 billion people worldwide experiencing some degree of hearing loss.

The features, including noise exposure information and Hearing Test results, will be accessible through Samsung Health. The Hearing Aid and Hearing Test features are set to launch on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and select markets in Q4 2026. Samsung emphasizes that this initiative is about enhancing the usability of earbuds in everyday health matters that people often overlook until they become problematic, rather than merely making them louder.