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

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.