Samsung gets FDA clearance for hearing aid feature in Galaxy Buds, taking on AirPods Pro

Samsung has received approval from the U.S. Food and Drug Administration (FDA) for a hearing aid feature in its Galaxy Buds wireless earbuds. The move puts the company in direct competition with Apple and its AirPods Pro hearing health offering.

The clearance allows Samsung to introduce software-based Hearing Test and Hearing Aid functions on compatible devices. The rollout is scheduled for the fourth quarter of this year. Standard consumer earbuds will turn into over-the-counter medical devices intended for adults aged 18 and older with perceived mild to moderate hearing loss.

Users will not need to visit an audiologist or buy separate prescription hardware. The system relies on a five-minute self-administered test launched through the Galaxy Buds app. The software uses pure-tone audiometry and evaluates each ear independently across different frequencies to create a personalized audiogram. Audio output is then automatically calibrated using NAL-NL2, a globally recognized fitting formula used in professional prescription hearing aids.

According to Samsung's press release, the company has been working on auditory health features for years. The first sound amplification tools appeared on the Galaxy Buds+ back in 2020. Later, Samsung collaborated with Vanderbilt University Medical Center, San Jose State University, and the National Acoustic Laboratories to validate its algorithms against traditional medical standards.

The regulatory approval comes amid broader changes in the hearables market, driven by the FDA's 2022 creation of the OTC hearing aid category. That move aimed to lower cost barriers and reduce the social stigma associated with traditional hearing aids.

As of now, the hearing aid feature is limited to the Galaxy Buds3 Pro at $218.35 and the Galaxy Buds4 Pro at $249.99. It requires a connected Samsung smartphone running One UI 8 or later to handle the clinical processing. For comparison, Apple's AirPods Pro 3 is available on Amazon at a 24% discount, priced at $189.99.