Samsung Galaxy Buds 4 Pro and 3 Pro get approved as hearing aids

Samsung has achieved a major milestone as its Galaxy Buds 4 Pro and Buds 3 Pro wireless earbuds have been officially approved as over-the-counter hearing aids. South Korea's Ministry of Food and Drug Safety has cleared the medical-grade feature set for the hardware.

This follows previous approval from the US FDA in August 2026, which greenlit the medical device capabilities for the region. The regulatory clearance from South Korea enables Samsung to roll out these advanced health features to additional global markets.

• The hearing solution features two main modules: Hearing Test and Hearing Aid.
• Designed specifically for users aged 18 and older experiencing mild to moderate hearing loss.
• The diagnostic test uses clinical-grade audiometry and takes about 5 minutes per session.

How the Hearing Test and Customization Work

Users can perform a comprehensive hearing check independently using the Galaxy Buds app on their Samsung Galaxy smartphone. The test generates an audiogram comparable to professional audiologist results, categorizing hearing capacity into four distinct levels ranging from normal to severe.

Once the hearing profile is established, the Galaxy Buds 4 Pro or Buds 3 Pro function as personalized hearing aids, dynamically boosting sound output for each ear. The devices utilize NAL-NL2 fitting technology commonly found in dedicated standalone medical hearing aids.

Advanced Noise Reduction and Beamforming

The hearing aid mode supports advanced audio enhancements, including ambient noise reduction to make speech much clearer during conversations. Beamforming technology is also integrated to channel sound efficiently and accurately directly into the wearer's ears.

Samsung follows in the footsteps of Apple, which introduced similar diagnostic hearing tests and personal sound amplification to its AirPods Pro lineup. Beyond audio accessories, Samsung recently secured regulatory clearance for sleep apnea detection features on its Galaxy Watch models.

Release Dates and Global Rollout

The Hearing Test and Hearing Aid features are scheduled to arrive for users in the United States during the fourth quarter of 2026. Wider international availability, including the South Korean market, is slated for early 2027.

For global tech markets and users, the integration of clinical-grade health tools into consumer earbuds represents a significant shift towards accessible personal healthcare. As regulatory approvals expand, these features bridge the gap between lifestyle technology and certified medical assistance.