Samsung Galaxy Buds 3 Pro and Galaxy Buds 4 Pro Gain FDA-Approved Hearing Aid Feature
Samsung is turning select Galaxy Buds earbuds into more than just devices for music, calls, and noise cancellation. The company has received FDA approval for a new hearing aid feature that will allow compatible earbuds to function as over-the-counter hearing aids.
For now, the feature will be available on two models: Galaxy Buds 3 Pro and Galaxy Buds 4 Pro. Once the update arrives, eligible users will be able to use these earbuds to help improve everyday hearing without needing a traditional prescription hearing aid.
The new Samsung Galaxy Buds hearing aid feature is designed for adults aged 18 and older. It starts with a built-in Galaxy Buds Hearing Test, which evaluates the user’s hearing ability in each ear. Samsung says the test provides medical-grade results and has been registered as Software as a Medical Device.
After the test is complete, users will see their hearing results categorized as normal hearing or as mild, moderate, severe, or profound hearing loss. Based on those results, the earbuds can be configured to amplify sounds the user may struggle to hear.
Samsung developed the over-the-counter hearing solution in collaboration with the National Acoustic Laboratories and Samsung Medical Center. The goal is to offer a more accessible hearing support option through earbuds many users may already be familiar with.
Once set up, the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro will adjust sound amplification based on each user’s hearing profile. The experience is personalized for each ear, which is important because hearing loss often differs between the left and right ear.
Users will also get several adjustment tools typically associated with premium hearing aids. These include the ability to control volume for both earbuds together or separately, reduce background noise, and choose the preferred direction of sound. This can help make conversations, outdoor environments, and daily listening more comfortable.
Setup will be handled through the Galaxy Buds menu in the Settings app on compatible Galaxy smartphones running One UI 8 or newer. Samsung has not confirmed whether people using non-Galaxy Android phones will be able to complete the hearing test or activate the hearing aid function through the Galaxy Buds app.
However, Samsung says users will be able to view hearing-related information in the Samsung Health app, including hearing test results and noise exposure insights. Samsung Health is available on Android and iPhone, which may make some hearing data accessible beyond Galaxy phone users.
The FDA approval puts Samsung in a growing category of consumer audio brands offering clinical-grade hearing support through wireless earbuds. With over-the-counter hearing aids becoming more common, features like this could make hearing assistance more affordable, convenient, and less intimidating for many people.
Samsung plans to begin rolling out the Galaxy Buds hearing aid feature in the United States and select approved markets in the fourth quarter of 2026. More markets and additional Galaxy Buds models may follow later, but for now, support is limited to the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro.
