Samsung’s Galaxy Buds are set to take on a new role in hearing support after the company received clearance from the US Food and Drug Administration (FDA) for a Hearing Aid feature.
The approval allows compatible Galaxy Buds to function as over-the-counter (OTC) hearing aids for people aged 18 and above who experience perceived mild to moderate hearing loss.
Users can access the Hearing Test through the Galaxy Buds menu in their device settings.
The results place hearing into one of five categories — normal, mild, moderate, severe or profound hearing loss.
Samsung has said the Hearing Aid and Hearing Test functions will launch on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and selected markets in Q4 2026.
Samsung’s Galaxy Buds are set to take on a new role in hearing support after the company received clearance from the US Food and Drug Administration (FDA) for a Hearing Aid feature.
The approval allows compatible Galaxy Buds to function as over-the-counter (OTC) hearing aids for people aged 18 and above who experience perceived mild to moderate hearing loss. The feature is designed for users who, for instance, struggle to follow conversations in noisy surroundings.
The FDA clearance is significant because OTC hearing aids can be purchased without a prescription or a visit to a hearing clinic in the US. Samsung said the feature will initially be offered on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and select approved markets in the fourth quarter of 2026.
The company is also combining the hearing aid function with a Hearing Test feature, which it says is registered as Software as a Medical Device (SaMD). The test is designed to assess hearing without requiring a separate app.
Users can access the Hearing Test through the Galaxy Buds menu in their device settings. The process takes about five minutes and uses pure-tone audiometry to test each ear separately. Samsung says the resulting audiogram has an accuracy comparable with a professional audiologist's assessment.
The results place hearing into one of five categories — normal, mild, moderate, severe or profound hearing loss. The Hearing Aid feature can then use this information to adjust sound amplification according to the user's hearing profile.
Rather than simply increasing overall volume, the system is designed to boost sounds that may be harder for a particular user to hear, including higher-frequency sounds, quieter voices and sounds from a distance. Samsung says the feature also incorporates noise reduction and beamforming technology to help distinguish sounds in front of the wearer from background noise.
The hearing system uses NAL-NL2, a formula widely used for fitting prescription hearing aids. Samsung developed the technology in collaboration with the National Acoustic Laboratories and Samsung Medical Center, with clinical validation studies carried out at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
The company has been working on hearing-related features in its earbuds for several years. In 2020, it introduced a Personal Sound Amplification Product feature on the Galaxy Buds+, which was subsequently clinically validated in 2021.
Samsung's latest move comes as hearing loss remains widespread globally. The World Health Organization estimates that more than 1.5 billion people experience some degree of hearing loss, with that number expected to rise to 2.5 billion by 2050.
The company said hearing-related information, including noise exposure and Hearing Test results, will also be available through Samsung Health, giving users a way to track their hearing alongside other health data.
The new features will not be available across the entire Galaxy Buds range. Samsung has said the Hearing Aid and Hearing Test functions will launch on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and selected markets in Q4 2026.
