[Edaily Reporter Shin Yeong-bin ] SamsungElectronics(005930)’s wireless earbuds, the “Galaxy Buds,” can now be used as hearing aids in the United States.

SamsungElectronics announced on the 12th that the “Hearing Aid” feature of the Galaxy Buds has received approval from the U.S. Food and Drug Administration (FDA).

Galaxy Buds models that support this feature can be used in the U.S. as over-the-counter (OTC) hearing aids for users aged 18 and older with mild to moderate hearing loss. There is no need to visit a hospital or obtain a doctor’s prescription.

The Galaxy Buds also include a “Hearing Test” feature that allows users to check their hearing status. This feature is registered as Software as a Medical Device (SaMD).

Users can access the Galaxy Buds menu in their smartphone settings to take a hearing test that takes about 5 minutes. No separate app is required. After testing each ear individually, the test generates an audiogram showing which frequencies the user has difficulty hearing.

The test results are categorized as normal or mild, moderate, severe, or profound hearing loss. Subsequently, the hearing aid feature automatically amplifies sounds that the user has difficulty hearing, based on their hearing status.

It adjusts the sound to help users hear high-frequency sounds, soft voices in the background, and voices from a distance more clearly. It also supports “noise cancellation,” which reduces ambient noise, and “beamforming,” which helps users focus on sounds coming from directly in front of them.

SamsungElectronics has applied the “NAL-NL2” standard—widely used in prescription hearing aids—to the Galaxy Buds. This technology allows for precise sound adjustments tailored to each user’s unique hearing condition.

The National Acoustics Laboratory (NAL) in Australia and Samsung Medical Center in Seoul participated in the development of these features. Clinical validation was also conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.

SamsungElectronics has steadily expanded its hearing-related features since first introducing the Personal Sound Amplifier (PSAP) function in the Galaxy Buds Plus in 2020. Users can also check their noise exposure levels and hearing test results in the Samsung Health app.

Hon Park, Vice President and Head of the Digital Health Team at SamsungElectronics’ MX Business Division, said, “Hearing health is a crucial factor in communicating with others and building relationships.” He added, “With this FDA approval, we will integrate hearing tests and hearing aid functions directly into the Galaxy Buds so that more users can easily manage their hearing health.”