Samsung Galaxy Buds 4 Pro and 3 Pro get approved as over-the-counter hearing aids

In a recent development, Samsung has been granted approval by South Korea's Ministry of Food and Drug Safety, allowing its Galaxy Buds 4 Pro and 3 Pro to serve as over-the-counter hearing aids. This follows the US FDA's green light in August 2026, which classified the feature as a medical device. The approval opens the door for Samsung to expand the availability of the hearing aid feature to additional countries.

The hearing aid feature is composed of two modules: Hearing Test and Hearing Aid. The Hearing Test functions as a software-based medical tool, while the Galaxy Buds serve as the hardware component of the over-the-counter hearing aid. Samsung states that the hearing aid is intended for users aged 18 and older who experience mild to moderate hearing loss. The technology utilized in the Galaxy Buds is known as NAL-NL2, which is also employed in standalone hearing aids.

To assess hearing, users can conduct a self-check using the Galaxy Buds app on their Samsung Galaxy phone. The test, which lasts five minutes per session, is clinically graded and covers both ears. The outcome is displayed as an audiogram, illustrating each ear's hearing capacity, comparable to results provided by an audiologist.

The test categorizes users as having normal hearing or hearing loss, with four levels ranging from mild to profound. Users can also access detailed test results and their profiles within the Samsung Health app.

Following the diagnosis, the Galaxy Buds 4 Pro or 3 Pro function as hearing aids, amplifying sound for both ears or individually, depending on the level of hearing loss. For instance, they can enhance voices during conversations or amplify vocals in a track, making them more audible for the user. The hearing aid also offers advanced features, such as noise reduction to improve speech comprehension in conversation and beamforming to direct sound effectively to the ears.

The Hearing Test and Hearing Aid will be released for US users in the fourth quarter of 2026, with availability in additional countries, including South Korea, starting early 2027. Samsung joins Apple, which introduced its own hearing aid feature in the AirPods Pro 2 and Pro 3. Both the Galaxy Buds and AirPods versions include a built-in hearing test for diagnosis and personalized sound amplification.