Samsung Galaxy Buds Gain FDA-Cleared Hearing Aid Stamp To Rival AirPods

by Aaron Leong — Wednesday, August 12, 2026, 11:32 AM EDT

Samsung Galaxy Buds4 Pro - Image: Samsung

Similar to what Apple started with its AirPods Pro, Samsung has secured U.S. Food and Drug Administration (FDA) clearance for an over-the-counter hearing aid feature for the Galaxy Buds, bringing clinical-grade hearing assistance directly to consumer wireless earbuds.

The approval basically allows Samsung to introduce a software-based Hearing Test and Hearing Aid feature to compatible devices, positioning the South Korean tech giant in direct competition with the AirPods Pro hearing health suite. Scheduled to roll out this Q4, the functionality transforms standard consumer earbuds into over-the-counter (OTC) medical devices tailored for adults aged 18 and older who experience perceived mild to moderate hearing loss.

Saving you a visit to the audiologist or needing separate prescription hardware, the system centers on a five-minute self-administered test accessed through the Galaxy Buds app. Utilizing pure-tone audiometry, the software evaluates each ear independently across varying frequencies to construct a personalized audiogram. This profile automatically calibrated audio output using NAL-NL2, a globally recognized standard fitting formula used in professional prescription hearing aids.

Galaxy Buds app hearing test - Image: Samsung

Once a tone map is created, the software selectively enhances targeted audio ranges that individuals struggle to perceive, such as high-pitched tones, distant voices, or soft whispers in crowded settings. To maintain speech clarity in chaotic environments, the system leverages multi-mic beamforming to isolate the voice of a speaker directly in front of the user while active noise cancellation algorithms suppress ambient background clutter. As an added bonus, all diagnostic data and noise exposure metrics sync to the Samsung Health app, giving users a continuous snapshot of their auditory wellness (alongside traditional fitness metrics).

According to its press announcement, Samsung’s entry into auditory health actually builds on years of clinical groundwork. The company first introduced sound amplification tools on the Galaxy Buds+ in 2020, later collaborating with institutions like Vanderbilt University Medical Center, San Jose State University, and the National Acoustic Laboratories to validate its algorithms against traditional medical standards.

The regulatory green light arrives amid a broader transformation in the hearables market, driven by the FDA’s 2022 creation of the OTC hearing aid category aimed at lowering cost barriers and reducing the social stigma surrounding traditional hearing aids. As of this writing, Samsung's hearing aid feature is limited to the Galaxy Buds3 Pro ($218.35) and Galaxy Buds4 Pro ($249.99), requiring a connected Samsung smartphone running One UI 8 or later to execute the clinical processing. Meanwhile, Apple's AirPods Pro 3 is on sale for $189.99 at Amazon (24% off).