Samsung turns Galaxy Buds into hearing aids: FDA approval arrives

The U.S. FDA (Food and Drug Administration) has approved the new hearing-aid function of the Galaxy Buds. The compatible Samsung earbuds can use this mode in a way similar to Apple’s AirPods Pro from Cupertino.

This is an important step forward for the premium TWS from the Asian tech giant, although for now it concerns only the US market.

Samsung Galaxy Buds as hearing aids: approval and launch by the end of the year

Using the Samsung Galaxy Buds as hearing aids: the new feature will soon debut on the brand’s earbuds. As noted at the outset, this is a novelty similar to what has been seen so far with the “Hearing aid” from Apple (also available in Italy since May).

Thanks to FDA approval, Samsung’s software has been registered as a medical device: the company has worked closely with the National Acoustic Laboratories, with rigorous validation studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.

Just like the Cupertino version, the feature is integrated directly into the earbuds and the companion app, without the need for separate software. Simply perform a hearing test in just 5 minutes to obtain a personalized profile: the hearing amplifier modulates sounds based on the user’s hearing difficulties.

The mode will be available for users aged 18 and older with mild to moderate hearing loss, through the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro earbuds. Samsung has confirmed the release of the feature starting from the fourth quarter of 2026, in the United States and other selected markets.