Samsung is turning its Galaxy Buds into something more useful than another pair of wireless earbuds. The company says its Galaxy Buds Hearing Aid feature has received clearance from the US Food and Drug Administration, allowing compatible Galaxy Buds 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 and above and does not require a prescription or clinic visit. Samsung says it can help people who struggle to follow conversations in noisy environments, bringing basic hearing support directly to a device they may already own.
The FDA clearance is significant because Samsung is moving beyond audio enhancement and into a regulated hearing-support category. It also builds on several years of work by the company in this area.
Galaxy Buds can test hearing and personalize amplification
Samsung’s hearing-health system combines two features: Hearing Test and Hearing Aid. The Hearing Test is already registered as Software as a Medical Device (SaMD) and uses pure-tone audiometry to test each ear separately.
Users can complete the test in around five minutes through the Galaxy Buds settings. Samsung says the software generates an audiogram and categorizes hearing as normal or into four stages of hearing loss: mild, moderate, severe and profound.
The Hearing Aid feature then uses those results to personalize amplification. Rather than simply making everything louder, it is designed to boost sounds that users have difficulty hearing, including higher frequencies, distant voices and quieter speech.
Samsung says the system also incorporates features such as noise elimination and beamforming, which can help reduce background noise and focus on sounds coming from in front of the user.
The company uses NAL-NL2, a formula recognized as a clinical standard for fitting prescription hearing aids, to personalize the experience according to each user’s hearing profile.
Samsung is pushing hearing care into everyday devices
The move is part of Samsung’s broader effort to make hearing support easier to access. The company says more than 1.5 billion people worldwide experience some degree of hearing loss, while cost, stigma and limited access to professional care can prevent people from using hearing aids.
Samsung began exploring the category in 2020 with a Personal Sound Amplification feature on the Galaxy Buds+, later building toward its Hearing Aid system with clinical validation and collaborations involving the National Acoustic Laboratories and Samsung Medical Center.
The company says hearing-related information, including noise exposure and Hearing Test results, will also be available through Samsung Health.
The Hearing Aid and Hearing Test features are scheduled to arrive on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and select approved markets in Q4 2026.
For Samsung, this is less about making earbuds louder and more about making them useful in a part of everyday health that people often ignore until it becomes a problem.