Samsung's Galaxy Buds 3 Pro gains FDA clearance for wearable hearing aid functions, challenging Apple in the emerging over-the-counter earbud market

Samsung has received FDA approval for its Galaxy Buds 3 Pro and upcoming Buds 4 Pro to serve as hearing assistance devices, marking a significant development in the rapidly evolving over-the-counter hearing aid market and positioning the company as a direct competitor to Apple.

Samsung has won US Food and Drug Administration clearance for a hearing-aid function in its Galaxy Buds 3 Pro and forthcoming Buds 4 Pro, bringing another set of consumer earbuds into a category that has been reshaped by over-the-counter regulation. The company says the feature will start reaching eligible users in the fourth quarter and is designed to turn the earbuds into a hearing assistance device for adults with perceived mild to moderate hearing loss.

The FDA’s over-the-counter hearing-aid rules, which apply to adults aged 18 and over, allow certain users to buy devices without a medical examination or prescription. The agency says the category is intended for people with mild to moderate hearing loss, while younger users or those with more serious impairment still need professional assessment and, in many cases, a prescription device.

Samsung said it developed the feature with the National Acoustic Laboratories and Samsung Medical Centre, and validated it through studies at Vanderbilt University Medical Centre, San Jose State University and the University of Memphis. Once available, users will be able to run a hearing test from the Galaxy Buds section of Settings. Samsung says the software will assess each ear separately and generate an audiogram, the graph clinicians use to describe hearing sensitivity across frequencies, before classifying hearing as normal or as mild, moderate, severe or profound loss.

For users flagged as having mild to moderate hearing loss, the system will increase hard-to-hear sounds such as high frequencies, whispers and distant speech. Samsung also plans to surface hearing insights in the Samsung Health app, alongside controls for noise reduction and beamforming, a signal-processing method that focuses on sound from in front of the wearer while dampening background noise.

Samsung’s product description does not replace medical care, and the company says the feature is not a substitute for diagnosis or treatment by a qualified clinician. Even so, the move places Samsung in direct competition with Apple, whose AirPods Pro hearing-aid function won FDA clearance in 2024 and helped establish the market for software-driven hearing assistance in mainstream earbuds.