Samsung is taking its Galaxy Buds beyond music and phone calls and into the regulated hearing-health market.
The new Samsung hearing aid feature has received clearance from the U.S. Food and Drug Administration (FDA), allowing compatible Galaxy Buds to function as over-the-counter hearing aids for adults aged 18 and older with perceived mild to moderate hearing loss.
The move brings Samsung directly into a growing category where consumer electronics and healthcare technology are starting to overlap.
Rather than requiring users to purchase a separate hearing device, Samsung plans to bring hearing assessment and personalized sound amplification directly to selected Galaxy earbuds.
Samsung Hearing Aid Feature Turns Galaxy Buds Into OTC Devices
Samsung says its FDA-cleared Hearing Aid feature is designed for adults who experience perceived mild to moderate hearing loss.
Once activated, compatible Galaxy Buds can adjust surrounding sounds according to an individual’s hearing profile. The system is designed to amplify frequencies that a user may struggle to hear while reducing distracting background noise.
The technology will initially work with the Galaxy Buds3 Pro and Galaxy Buds4 Pro.
Samsung plans to make its Hearing Aid and Hearing Test features available in the United States and selected approved markets during the fourth quarter of 2026. Full functionality will require a compatible Galaxy device running One UI 8 or later.
That means the feature is FDA-cleared now, but consumers will have to wait for the planned software rollout before they can use it.
How the Galaxy Buds Hearing Test Works
A major part of Samsung’s approach is a built-in Hearing Test.
Instead of requiring users to visit a clinic before setting up the feature, the test can be performed through the Galaxy Buds settings on a compatible Galaxy device.
Samsung says the self-administered assessment takes about five minutes and uses pure-tone audiometry to test each ear individually. The system then produces an audiogram representing the user’s hearing levels.
Results can classify hearing as normal or indicate different levels of hearing loss.
The hearing profile is then used to personalize the Samsung hearing aid functionality.
For example, if the assessment finds that a person has more difficulty hearing certain higher frequencies, the earbuds can adjust amplification around those frequencies instead of simply making every sound louder.
That personalized approach is important because hearing loss can differ considerably between individuals and even between a person’s left and right ears.
Galaxy Buds Can Adapt Sound to the User
After completing the Hearing Test, the Hearing Aid feature uses the resulting profile to determine which sounds need greater amplification.
Samsung says this could include high-frequency sounds, quieter speech and distant voices.
The system also includes technologies more commonly associated with dedicated hearing aids.
One is beamforming, which can help the microphones focus on sound coming from a particular direction. Another is noise reduction, designed to suppress unwanted background noise and make important sounds easier to distinguish.
Compatible Galaxy Buds will use the NAL-NL2 fitting formula, which Samsung describes as a widely recognized clinical approach for configuring hearing aids according to individual hearing profiles.
Hearing-related information, including Hearing Test results and noise-exposure data, will also be accessible through Samsung Health.
Samsung Has Been Working on Hearing Technology for Years
Samsung’s move into OTC hearing aids did not happen overnight.
The company introduced a Personal Sound Amplification Product feature on the Galaxy Buds+ in 2020. It later highlighted clinical research suggesting that the Ambient Sound function on Galaxy Buds Pro could help some people with mild to moderate hearing loss communicate more effectively.
The new FDA clearance takes that concept considerably further.
Instead of positioning Galaxy Buds simply as consumer earbuds with accessibility features, Samsung can now offer compatible models as OTC hearing aids under the cleared functionality for their intended adult users.
Samsung says development of the new system included collaboration with the National Acoustic Laboratories and Samsung Medical Center, with validation studies conducted at institutions including Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Samsung Hearing Aid Feature Follows Apple’s AirPods Push
Samsung is not the first major consumer electronics company to turn wireless earbuds into regulated OTC hearing devices.
In September 2024, the FDA authorized Apple’s Hearing Aid Feature for compatible AirPods Pro, describing it at the time as the first OTC hearing-aid software device authorized by the agency.
Samsung’s entry gives Android and Galaxy users another major option.
It also strengthens a broader shift in the earbud market.
Premium earbuds have traditionally competed through music quality, active noise cancellation, microphones and battery life. Increasingly, hearing health could become another major battleground.
The earbuds people already carry every day may gradually take on functions that previously required separate medical or specialist devices.
Why OTC Hearing Aids Matter
The creation of the OTC hearing-aid category in the United States was intended to make hearing support easier to access for adults with perceived mild to moderate hearing loss.
Eligible OTC products can be purchased without requiring a traditional prescription or fitting by a hearing professional.
Integrating that functionality into mainstream earbuds could potentially lower another barrier: familiarity.
Some users may feel more comfortable wearing a device that looks like an ordinary pair of wireless earbuds rather than a traditional hearing aid.
There is also a convenience advantage. The same Galaxy Buds could potentially be used for music, calls, entertainment and hearing assistance rather than requiring several different devices.
The Feature Is Not Intended for Every Type of Hearing Loss
There are important limitations.
Samsung says the feature is intended for adults aged 18 and older with perceived mild to moderate hearing loss. It is not presented as a replacement for professional diagnosis or treatment when medical attention is required.
People experiencing more serious hearing difficulties or other concerning ear or hearing symptoms may still require evaluation by a qualified healthcare professional.
The Hearing Test can provide information used by the earbuds to personalize amplification, but the existence of an easy-to-use consumer test does not eliminate the role of professional hearing care.
Galaxy Buds Are Becoming More Than Earbuds
FDA clearance gives Samsung a significant opportunity to expand what consumers expect from wireless earbuds.
The Samsung hearing aid feature turns the Galaxy Buds3 Pro and Galaxy Buds4 Pro from entertainment accessories into devices that can also provide regulated OTC hearing support for eligible adults.
It is another sign that the line separating everyday consumer technology from digital health products is becoming increasingly thin.
Smartwatches have already evolved from simple notification screens into devices capable of tracking numerous health indicators. Earbuds could now follow a similar path.
For Samsung, that means Galaxy Buds will increasingly compete not only on how well they reproduce music, but also on how effectively they can help users hear the world around them.
With the U.S. rollout planned for Q4 2026, the company’s entry into the OTC hearing-aid space could also intensify competition with Apple and encourage other earbud makers to treat hearing health as a core feature rather than a niche accessibility option.
