Samsung Galaxy Buds Get FDA-Cleared Hearing Aid Feature — Rolling Out Q4 2026

Samsung announced on August 11 that the FDA has cleared its Hearing Aid feature for the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro. The earbuds can now serve as over-the-counter hearing aids for adults 18 and older with perceived mild to moderate hearing loss.

How It Works

• Hearing Test: A self-administered five-minute test per ear, built into Galaxy Buds settings, registered as a Software as a Medical Device (SaMD)
• Hearing Aid mode: Uses test results to tailor amplification to the listener{"'"}s specific hearing profile
• Clinical validation: Studies conducted at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis
• Developed with: National Acoustic Laboratories and Samsung Medical Center

Requirements

The feature requires a compatible Galaxy smartphone running One UI 8 or later. It will be available on the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro only — the standard Buds models are not supported.

When It Ships

Samsung says the feature will arrive in Q4 2026 in the US and other approved markets via a software update.

How It Compares

Apple{"'"}s AirPods Pro 3 already offer FDA-cleared hearing aid functionality with hearing loss compensation built in. Samsung{"'"}s clearance brings Android users their first comparable option from a major manufacturer. At $140 for the Galaxy Buds 3 Pro on Amazon, the Samsung option is notably cheaper than the $199 AirPods Pro 3.

Browse all wireless earbuds or compare AirPods Pro 3 prices.