As reported on Fierce Biotech, Samsung Electronics has obtained clearance from the U.S. Food and Drug Administration (FDA) for software features that transform select Galaxy Buds earbuds into over-the-counter (OTC) hearing aids while also enabling users to evaluate their hearing health directly through the device.
The newly authorized functionality includes a built-in hearing assessment tool that Samsung says meets medical-device software standards and can provide clinically validated hearing test results. By combining hearing evaluation and amplification capabilities within a single wearable product, the company aims to simplify access to hearing support.
According to Samsung, users can access the features natively through the Galaxy Buds settings menu without downloading additional applications. The hearing assessment can be completed in about five minutes, after which the earbuds can tailor hearing assistance settings based on the user’s results.
The company noted the growing prevalence of hearing loss worldwide, referencing World Health Organization projections that more than 1.5 billion people currently live with some level of hearing impairment, a number expected to increase to 2.5 billion by 2050.
Hon Pak, senior vice president and head of Samsung’s digital health team within its mobile experience business, said the FDA clearance will help broaden availability of hearing support by embedding both testing and hearing-assistance functions directly into Galaxy Buds devices.
Samsung’s latest milestone builds on several years of development in the hearing technology space. The company first introduced personal sound amplification product (PSAP) capabilities with Galaxy Buds+ in 2020. In 2021, those features were clinically validated as a beneficial hearing-support option for individuals experiencing hearing difficulties.
Development of the newly cleared features involved collaboration with Australia’s National Acoustic Laboratories and Samsung Medical Center in South Korea. Clinical studies supporting the technology were carried out by researchers at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
Samsung said the enhanced hearing features are scheduled to launch in the United States and other approved markets later this year.
The approval comes as consumer audio devices continue to gain a foothold in hearing care. In 2022, the FDA established regulations allowing adults with mild-to-moderate hearing loss to purchase hearing aids without a prescription. Apple subsequently received the first FDA de novo authorization for OTC hearing-aid software integrated into its AirPods product line.
As technology companies continue to merge health capabilities with everyday consumer electronics, Samsung’s FDA-cleared Galaxy Buds features represent another example of how wearable devices are expanding access to hearing screening and hearing-assistance tools outside traditional clinical settings.
