Samsung Galaxy Buds Get FDA Clearance as OTC Hearing Aids: Models, Features, and Launch Date

On August 11, 2026, Samsung announced that the U.S. Food and Drug Administration (FDA) had cleared its Galaxy Buds Hearing Aid feature, turning select wireless earbuds into over-the-counter (OTC) hearing aids . The clearance covers Galaxy Buds3 Pro and Galaxy Buds4 Pro and marks Samsung's entry into the OTC hearing aid market, following Apple's AirPods Pro . Here is everything you need to know about the feature, how it works, and when you can get it.

Which Galaxy Buds models support the hearing aid feature?

Two models support the feature:

• Galaxy Buds3 Pro
• Galaxy Buds4 Pro

Users also need a compatible Galaxy device running One UI 8 or later to access the hearing health features .

How does Samsung's hearing health system work?

Samsung's system centers on two integrated features accessible directly in the Galaxy Buds Settings menu — no separate app is required .

Hearing Test

Users can complete a self-administered Hearing Test in about five minutes. Using clinical-grade pure-tone audiometry, the software tests each ear individually and generates an audiogram with accuracy comparable to a professional audiologist's evaluation. The results categorize hearing as normal, mild, moderate, severe, or profound . The Hearing Test is registered as a Software as a Medical Device (SaMD) .

Hearing Aid

Based on the audiogram, the Hearing Aid feature amplifies the specific frequencies the user has difficulty hearing — such as high frequencies, whispers, and distant voices. The system also includes noise elimination and beamforming to create a more focused sound .

The NAL-NL2 clinical standard

Samsung applies the NAL-NL2 formula, recognized globally as the clinical standard for fitting prescription hearing aids. This ensures amplification is personalized to each user's unique hearing profile .

Samsung Health integration

Hearing-related insights — including noise exposure levels and test results — are accessible in the Samsung Health app .

What clinical research partnerships supported its development?

Samsung's hearing health development began in 2020 with a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+, which was clinically validated in 2021 . Key collaborators and validation partners include:

• National Acoustic Laboratories (NAL) — collaborated directly on the OTC solution
• Samsung Medical Center (SMC) — collaborated directly on the OTC solution
• Vanderbilt University Medical Center — conducted clinical validation studies
• San Jose State University — conducted clinical validation studies
• University of Memphis — conducted clinical validation studies

When will the feature launch?

The Hearing Aid and Hearing Test features will be available in the U.S. and select approved markets starting in Q4 2026 .

How does this compare to Apple's offering?

Apple introduced OTC hearing aid functionality for AirPods Pro 2 and AirPods Pro 3 in 2024. Samsung's system also includes a built-in hearing test and uses clinical standards to personalize amplification, making it a direct competitor in the consumer hearing health space .

Key takeaway

Samsung's FDA clearance means millions of Galaxy Buds users may soon be able to address mild to moderate hearing loss without a prescription or clinic visit — using earbuds they already own. The feature launches later this year, and users will need a Galaxy Buds3 Pro or Galaxy Buds4 Pro with a compatible Galaxy phone running One UI 8 or later.