11 August 2026: Samsung has announced that its hearing aid feature for selected Galaxy Buds has received clearance from the United States Food and Drug Administration. The feature is intended to offer more accessible everyday hearing support.
The feature allows compatible Galaxy Buds to work as an over the counter hearing aid for adults aged 18 and over who experience perceived mild to moderate hearing loss. Samsung says this may include people who find it difficult to follow conversations in noisy places. Because it is an over the counter option, eligible users do not need a prescription or clinic visit before using it.
A related Hearing Test can be completed through the Galaxy Buds settings in about five minutes. Samsung describes the test as registered software as a medical device that provides medical grade results. The hearing aid settings and test are integrated into the earbuds experience rather than requiring a separate application.
Samsung says it worked with the National Acoustic Laboratories and Samsung Medical Center on the technology. Clinical validation studies involved Vanderbilt University Medical Center, San Jose State University and the University of Memphis. This builds on earlier accessibility work, including personal sound amplification in Galaxy Buds Plus and enhanced ambient sound features in later models.
Australian readers should note that FDA clearance applies to the United States. Local regulatory approval, model support and release timing may be different.
Official source: https://news.samsung.com/global/samsungs-hearing-aid-feature-on-galaxy-buds-cleared-by-fda