FDA Clears Samsung Software That Turns Galaxy Buds Into Over-the-Counter Hearing Aids

Samsung Electronics has received U.S. Food and Drug Administration clearance for a software feature that lets compatible Galaxy Buds earbuds work as an over-the-counter hearing aid, the company announced on August 11. The Hearing Aid feature is intended for adults 18 and older with perceived mild to moderate hearing loss and does not require a prescription or a clinic visit, Samsung said.

The clearance puts Samsung alongside other consumer technology companies seeking FDA authorization for over-the-counter hearing aid software, including Apple, which added hearing aid capabilities to its AirPods Pro, The Hearing Review reported on August 14.

A built-in test and a fitting formula

Samsung describes the product as two connected features that live in the Galaxy Buds menu of a phone's settings, with no separate app. The first is a Hearing Test that users take on their own in about five minutes. According to the company, it uses pure-tone audiometry to test each ear separately, generates an audiogram and sorts the result into normal hearing or one of four stages of hearing loss: mild, moderate, severe or profound. Samsung said the Hearing Test is registered as Software as a Medical Device.

The second is the Hearing Aid feature itself, which amplifies the sounds a user has trouble hearing, such as high frequencies and distant voices, based on that user's test results. Samsung said it fits amplification with NAL-NL2, a formula widely used to fit prescription hearing aids, and includes noise reduction and beamforming to focus on sounds in front of the wearer. The Hearing Review noted that NAL-NL2 is no longer the newest version of the formula but has long served as a clinical standard.

Samsung's announcement did not give a 510(k) number or describe the data submitted to the FDA. The company said it developed the feature with the National Acoustic Laboratories and Samsung Medical Center, and that validation studies were run at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.

"With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds," said Hon Pak, senior vice president and head of the digital health team for Samsung's Mobile eXperience business.

Rollout and limits

The two features will be available on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the U.S. and select approved markets in the fourth quarter of 2026, Samsung said. Full support requires a compatible Galaxy device running One UI 9 or later, according to the release, and availability may vary by market, model or paired device.

Samsung said the Hearing Aid feature is not a substitute for professional diagnosis or treatment by a qualified clinician. The company has not announced pricing or a specific launch date, The Hearing Review reported.

The feature builds on a personal sound amplification function Samsung added to the Galaxy Buds+ in 2020, which the company said was clinically validated in 2021. Hearing results and noise exposure data will also be visible in the Samsung Health app, according to the company.