Samsung is expanding the health capabilities of its wireless earbuds. The company has announced that its new Hearing Aid feature for Galaxy Buds has received clearance from the U.S. Food and Drug Administration (FDA).
With the new functionality, compatible Galaxy Buds can be used as over-the-counter hearing aids for adults aged 18 and above experiencing perceived mild to moderate hearing loss. Samsung says the feature is designed to provide easier access to hearing support without requiring a prescription or a visit to a clinic.
Galaxy Buds Get Built-In Hearing Test
A key part of Samsung’s new hearing experience is the Hearing Test. Users can access the test through the Galaxy Buds settings and complete it in roughly five minutes.
The software uses pure-tone audiometry to test each ear separately and identify areas where the user may have difficulty hearing. The resulting hearing profile can then be used to personalise the Hearing Aid feature.
Samsung says the Hearing Test is registered as Software as a Medical Device (SaMD) in the US.
Personalised Sound Amplification
Once the hearing test is completed, the Galaxy Buds can adjust sound amplification according to the user’s individual hearing profile.
The feature is designed to enhance sounds that may be difficult to hear, including higher-frequency sounds, nearby voices and voices coming from farther away.
Samsung has also incorporated technologies such as noise elimination and beamforming. These are intended to help concentrate on sounds in front of the wearer while reducing unwanted background noise.
Galaxy Buds3 Pro and Buds4 Pro to Get the Feature
The FDA-cleared hearing functionality will not initially be available across the entire Galaxy Buds range.
Samsung says the Galaxy Buds3 Pro and Galaxy Buds4 Pro will support both the Hearing Test and Hearing Aid features. The rollout is planned for Q4 2026 in the US and selected markets where regulatory approval is available.
A compatible Galaxy device running One UI 8 or later is also required for the complete experience.
Samsung Uses NAL-NL2 Hearing-Aid Fitting Formula
Samsung says its compatible Galaxy Buds use the NAL-NL2 fitting formula, which is recognised internationally for hearing-aid fitting.
The company developed the new technology in collaboration with the National Acoustic Laboratories (NAL) and Samsung Medical Center. Samsung also says the technology has undergone clinical validation involving institutions including Vanderbilt University Medical Center, San Jose State University and the University of Memphis.
Hearing Information Comes to Samsung Health
The company is also connecting the new hearing features with its broader health ecosystem.
Users will be able to access hearing-related information, including Hearing Test results and noise-exposure data, through the Samsung Health app. This gives users a central place to review hearing-related insights alongside other health information.
Samsung’s Push Into Hearing Health
This is not Samsung’s first attempt to bring hearing assistance to its earbuds. The company introduced a Personal Sound Amplification Product (PSAP) feature with the Galaxy Buds+ in 2020.
Samsung says that feature was clinically validated in 2021 and helped establish the foundation for its latest hearing technology.
The FDA clearance now marks a more significant step, as compatible Galaxy Buds can be positioned as OTC hearing aids for their intended users in the US.
What Users Should Know
The new feature is intended for adults with perceived mild to moderate hearing loss. It is not designed to replace professional medical diagnosis or treatment.
Availability will also depend on the country, regulatory approval, compatible Galaxy Buds model and connected Galaxy device.
Bottom Line
Samsung’s latest move shows how wireless earbuds are increasingly becoming more than traditional audio accessories. With the Galaxy Buds3 Pro and Buds4 Pro, the company is bringing hearing testing and personalised amplification into a familiar consumer device.
The FDA clearance could make hearing support more accessible to eligible users, while Samsung’s planned Q4 2026 rollout will determine how widely the feature is adopted across supported markets.
