Samsung turns Galaxy Buds3 Pro into FDA-cleared hearing aids

Samsung has received FDA clearance for a Hearing Aid feature that will let the Galaxy Buds3 Pro and Galaxy Buds4 Pro function as over-the-counter hearing aids. It is designed for adults with perceived mild to moderate hearing loss, with the first rollout planned for the US and selected approved markets in Q4 2026.

The hearing test tunes each ear separately

The Hearing Test and Hearing Aid features are accessed through the Galaxy Buds menu in Settings, so there is no separate app to install. The test uses pure-tone audiometry, playing sounds at different frequencies to measure the hearing level of each ear.

Samsung’s screenshots show the results split into left and right ears, complete with average decibel figures and an audiogram covering frequencies from 250Hz to 8kHz. The software then places the result into one of five categories ranging from normal hearing to profound hearing loss.

Once the test is complete, the user can move straight into the Hearing Aid setup. The interface allows volume to be controlled for both earbuds together or adjusted separately, while sound can be picked up from all around or focused towards the front.

There is also a background noise reduction slider. That should be useful in places such as restaurants and busy rooms, where making out a conversation is often harder than simply hearing that someone is speaking.

Samsung says its software uses the NAL-NL2 fitting formula, which is widely used when configuring prescription hearing aids. Noise reduction and beamforming are also used to bring voices into focus while reducing some of the surrounding sound.

Galaxy Buds3 Pro owners are included

Perhaps the best part of the announcement is that Samsung is not keeping the feature exclusive to its newest earbuds. Galaxy Buds3 Pro owners are included alongside the Galaxy Buds4 Pro, potentially adding a substantial new use without requiring another hardware purchase.

The standard Galaxy Buds3 and Galaxy Buds4 are not supported. Samsung also says full functionality requires a compatible Galaxy device running One UI 8 or later, so buyers should not assume the hearing aid mode will work fully when the earbuds are paired with any Bluetooth phone.

The company has offered forms of hearing assistance for several years. A Personal Sound Amplification Product mode arrived on Galaxy Buds+ in 2020, with a later study suggesting the earbuds could help people follow conversations more easily.

A personal sound amplifier is intended to make environmental sounds louder for someone with normal hearing, while an OTC hearing aid is a medical device intended to compensate for hearing loss. We explored that difference in our Olive Smart Ear review, where personalised amplification was already beginning to blur the line between earbuds and dedicated hearing products.

Samsung is not the first major earbud maker to take this step. Apple rSamsung is not the first major earbud maker to take this step. Apple received FDA authorisation for its AirPods Pro 2 hearing aid software in 2024. That makes Samsung’s announcement partly a catch-up move. Still, bringing a comparable option to Galaxy owners matters, particularly because the existing Buds3 Pro will receive it as well.