The Galaxy Buds Hearing Aid feature, which enables compatible Galaxy Buds to serve as over-the-counter hearing aids for adults 18 years of age and older with perceived mild to moderate hearing loss, has been approved by the U.S. FDA.

The tech giant said that users with Galaxy Buds3 Pro and Galaxy Buds4 Pro can also assess their hearing with the Galaxy Buds Hearing Test feature, reports MobiHealthNews.

The Hearing Aid and Hearing Test features will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and select approved markets in Q4, 2026.

Clinical-grade, pure-tone audiometry is used in the five-minute self-administered hearing test. The user's hearing impairments are determined by testing each ear separately.

Hearing loss is then classified as normal or mild, moderate, severe, or profound, according to the test's results, which the business claimed are comparable to a professional audiologist's assessment.

The Hearing Aid feature then personalizes and adjusts the sound according to the results of the Hearing Test.

According to the manufacturer, the hearing aid also offers beamforming, a signal-processing method that employs several microphones to concentrate sound in front of a person while eliminating background noise from the side or back.

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"Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world," Hon Pak, senior VP and head of the digital health team for the Mobile eXperience (MX) business at Samsung Electronics, said in a statement.

"With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating Hearing Test and Hearing Aid functionality directly into the Galaxy Buds."

The Larger Trend

A final rule allowing access to over-the-counter hearing aids was released by the FDA in 2022.

Two years later, Apple's Hearing Aid Feature became the first over-the-counter software for hearing aids that was approved by the US FDA and intended to be used with consumer electronics.

In September 2024, Apple obtained FDA approval under the De Novo procedure for the hearing aid software integrated into its AirPods Pro 2 headphones.

The software of the AirPods Pro 2 used machine learning to intelligently adapt sound to users' hearing needs, enabling the headphones to operate as clinical-grade hearing aids.

The company later obtained regulatory approvals in other countries, launching in the UK in February 2025 and Australia in March 2025.