Samsung announced that the U.S. Food and Drug Administration has cleared the Galaxy Buds Hearing Aid feature, which will launch in Q4 2026. The feature enables compatible Samsung Galaxy Buds to function as an over-the-counter hearing aid for users 18 years and older seeking a solution for perceived mild to moderate hearing loss.
The Galaxy Buds Hearing Test is registered as a Software as a Medical Device and is designed to diagnose potential hearing loss and deliver medical-grade results. Built directly into Galaxy Buds, the feature requires no separate app: users can run the Hearing Test from the Buds Settings menu in about five minutes. Based on those results, the Hearing Aid function amplifies sounds the user has difficulty hearing—such as distant voices and high frequencies—personalized to the user’s hearing profile.
Galaxy Buds Hearing Aid: testing, validation and how it works
Samsung says it developed the solution in close collaboration with the National Acoustic Laboratories and the Samsung Medical Center. Robust clinical validation studies were also conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
Hearing loss affects a large and growing number of people worldwide: the World Health Organization estimates more than 1.5 billion people experience some degree of hearing loss, a figure projected to reach 2.5 billion by 2050. According to Samsung’s announcement, factors such as high cost, social stigma and limited access to professional care often keep many people who could benefit from hearing aids from using them.
