The US Food and Drug Administration has cleared a hearing aid feature for Samsung Electronics' Galaxy Buds, enabling the wireless earbuds to serve as over-the-counter hearing aids without requiring a prescription or a visit to a clinic, Samsung announced Tuesday.

The feature will initially be available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States and select other markets starting in the fourth quarter. Samsung has not announced a rollout timeline for South Korea, and the FDA clearance applies exclusively to the US market.

The feature is designed for individuals aged 18 and older who experience mild to moderate hearing loss. It can amplify sounds that are typically difficult to hear, including high-frequency sounds, whispers, and distant voices. The earbuds also incorporate noise reduction and beamforming technology, which focuses on sounds originating from the front while suppressing background noise.

Users must first complete a hearing test of approximately five minutes through the Galaxy Buds settings menu. The test produces an audiogram for each ear, which the system then uses to calibrate sound amplification according to the user's individual hearing profile. Hearing test results and related data can be reviewed in the Samsung Health app.

Samsung has been building hearing-related capabilities into its earbuds since 2020, when it introduced a Personal Sound Amplification Product feature on the Galaxy Buds+. The FDA clearance places Samsung among a growing group of consumer electronics companies leveraging the OTC hearing aid category, which the agency established in 2022 for adults with perceived mild to moderate hearing loss. Apple received FDA clearance for a comparable clinical-grade hearing aid feature on its AirPods Pro 2 in 2024.

"Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world," said Hon Pak, head of the Digital Health Team for Samsung Electronics' Mobile eXperience Business, in a press release. "The FDA clearance lowers the threshold to hearing support and makes daily care more accessible."

Samsung developed the feature in collaboration with the National Acoustic Laboratories and Samsung Medical Center, with clinical validation studies conducted at Vanderbilt University Medical Center.

According to the World Health Organization, more than 1.5 billion people worldwide currently live with hearing loss, a number projected to rise to 2.5 billion by 2050. Cost, stigma, and limited access to care remain among the primary barriers to hearing-aid adoption. The FDA's OTC framework was designed in part to address those barriers by allowing devices to be sold directly to consumers without a medical exam, and earbud-based hearing aids may further reduce friction by repurposing hardware that users already own.