US FDA clears Galaxy Buds Hearing Aid feature, launches in Q4, 2026

Samsung announced today that the U.S. Food and Drug Administration has cleared the Galaxy Buds Hearing Aid feature. This feature enables compatible Samsung Galaxy Buds to function as an over-the-counter hearing aid.

It will provide users 18 years and older with a convenient solution to address perceived mild to moderate hearing loss with just their Samsung wireless earbuds.

The Galaxy Buds Hearing Test feature can be used to diagnose any potential hearing loss. This feature is registered as a Software as a Medical Device and delivers medical-grade results.

Samsung has worked on this new solution closely alongside 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.

These features are built directly into Galaxy Buds and don't require any separate app. The Hearing Test can be conducted through the Buds Settings menu in just five minutes. Based on those results, the Hearing Aid feature will then amplify the sounds that users have difficulty hearing, such as distant voices, high frequencies, etc, that are personalized to the user's profile.

Hearing loss is a very common condition, and yet it remains one of the most overlooked worldwide. World Health Organization estimates put the number of people who experience some degree of hearing loss at more than 1.5 billion. It's projected to reach 2.5 billion people by 2050.

Yet, often due to high cost, social stigma or limited access to professional care, many people who could benefit from hearing aids don't use them.

Samsung confirmed today that the Hearing Aid and Hearing Test features will be available on the Galaxy Buds 3 Pro and the Galaxy Buds 4 Pro in the United States and select other markets in Q4 2026.