Samsung's Galaxy Buds can now serve as hearing aids with adjustable sound enhancement features.

      Samsung receives FDA approval for Galaxy Buds Hearing Aid feature

      Samsung is enhancing the functionality of its Galaxy Buds beyond just being another set of wireless earbuds. The company has announced that the Galaxy Buds Hearing Aid feature has been approved by the US Food and Drug Administration, enabling compatible Galaxy Buds to serve as over-the-counter (OTC) hearing aids for adults with perceived mild to moderate hearing loss.

      This feature is intended for users aged 18 and older and does not need a prescription or a visit to a clinic. Samsung claims it can assist individuals who find it challenging to hear conversations in noisy settings, providing essential hearing support through a device they may already own.

      The FDA approval is noteworthy as Samsung expands its focus from audio enhancement into a regulated hearing-support domain. This development is the result of several years of effort by the company in this field.

      Galaxy Buds can evaluate hearing and customize amplification

      Samsung's hearing-health system includes two main functions: Hearing Test and Hearing Aid. The Hearing Test has already been registered as Software as a Medical Device (SaMD) and utilizes pure-tone audiometry to assess each ear individually.

      Users can complete the test in about five minutes via the Galaxy Buds settings. Samsung states that the software creates an audiogram and categorizes hearing as normal or classifies it into one of four stages of hearing loss: mild, moderate, severe, and profound.

      The Hearing Aid function uses these results to tailor amplification. Instead of simply increasing volume across the board, it is designed to enhance sounds that users struggle to hear, such as high frequencies, distant voices, and softer speech.

      Samsung also incorporates features like noise reduction and beamforming, which help minimize background noise and concentrate on sounds coming from in front of the user.

      The company employs the NAL-NL2 formula, recognized as a clinical standard for fitting prescription hearing aids, to customize the experience based on each user’s hearing profile.

      Samsung aims to integrate hearing care into everyday devices

      This initiative is part of Samsung's wider goal to improve access to hearing support. The company reports that over 1.5 billion people globally experience some degree of hearing loss, and barriers such as cost, social stigma, and limited access to professional care can prevent individuals from obtaining hearing aids.

      Samsung began exploring this domain in 2020 with the introduction of a Personal Sound Amplification feature on the Galaxy Buds+, subsequently developing its Hearing Aid system with clinical validation and partnerships with organizations like the National Acoustic Laboratories and Samsung Medical Center.

      Samsung states that hearing-related data, including noise exposure and Hearing Test outcomes, will also be accessible through Samsung Health.

      The Hearing Aid and Hearing Test features are expected to launch on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and selected approved markets in the fourth quarter of 2026.

      For Samsung, this move focuses less on simply amplifying sound and more on providing functionality in an aspect of daily health that is frequently overlooked until it becomes an issue.