Samsung's Galaxy Buds Just Became FDA-Cleared Hearing Aids

Samsung Enters the OTC Hearing Aid Market

Samsung announced on August 11, 2026 that its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration. The clearance allows compatible Galaxy Buds to function as an over-the-counter hearing aid — no prescription, no audiologist appointment, and no clinic visit required.

The feature is intended for adults 18 years and older who perceive that they have mild to moderate hearing loss. That framing matters: this is not a replacement for professional care in cases of significant hearing loss, but rather a self-directed option for the large group of people who suspect something has changed and have never done anything about it.

Which Buds, Which Phones, and When

Samsung plans to roll out the Hearing Aid and Hearing Test features on the Galaxy Buds3 Pro and Galaxy Buds4 Pro, with availability in the United States and other approved markets targeted for the fourth quarter of 2026.

There are some compatibility caveats worth noting before you plan around it:

• Full functionality requires a compatible Galaxy device running One UI 8 or later.
• Availability varies by market, by Buds model, and by the paired device.
• The supported earbuds are the Galaxy Buds3 Pro and Galaxy Buds4 Pro.

In other words, this is a Galaxy-ecosystem feature first and foremost — the earbuds alone aren't enough.

The Five-Minute Hearing Test

The gateway to the Hearing Aid feature is a self-administered Hearing Test that takes roughly five minutes. It uses pure-tone audiometry, the same basic method used in clinical screening, and tests each ear individually before generating an audiogram of the results.

The test is registered as Software as a Medical Device (SaMD), and Samsung says its results are comparable in accuracy to a professional evaluation. Once complete, results are categorized as normal or as one of four stages of hearing loss:

• Mild
• Moderate
• Severe
• Profound

That categorization does double duty — it configures the amplification profile for users in the intended range, and it signals to others that a conversation with a professional may be the better next step.

How the Hearing Aid Feature Works

Rather than applying a generic volume boost, the Hearing Aid feature personalizes amplification using NAL-NL2, a long-established clinical standard fitting formula used for prescription hearing aids. The result is targeted amplification of the sounds people with mild to moderate loss tend to miss: high frequencies, whispers, and distant voices.

Samsung pairs that with noise elimination and beamforming, which focus on sounds coming from in front of the user while suppressing background noise — the classic problem case of trying to follow one voice in a crowded restaurant.

Both the Hearing Test and the Hearing Aid feature are built directly into the Galaxy Buds menu in device Settings, so there's no separate hearing aid app to download, register, or manage.

Catching Up to Apple — and Building on Samsung's Own Hearing Work

Samsung is not first to this idea. Apple introduced FDA-authorized hearing aid functionality for the AirPods Pro 2 in 2024 and carried it forward into the AirPods Pro 3. Samsung's clearance brings a comparable self-fitting, over-the-counter option to Android users — arguably the more consequential development, given the size of the Android install base.

It also builds on Samsung's own history in this space. The company added a personal sound amplification product (PSAP) feature to the Galaxy Buds+ back in 2020, well before any regulatory clearance. The difference now is the label: a PSAP is a consumer amplification tool, while an FDA-cleared OTC hearing aid is a regulated medical device.

Why Mainstream Earbuds Matter for Hearing Health

The scale of the problem explains the interest. The World Health Organization estimates that more than 1.5 billion people globally experience some degree of hearing loss, a figure projected to reach 2.5 billion by 2050.

Adoption of hearing aids, however, lags well behind need. Commonly cited barriers include:

• Cost
• Stigma attached to wearing a visible hearing aid
• Limited access to hearing care

Everyday earbuds with built-in testing and fitting chip away at several of those at once. The hardware is already in millions of pockets and already socially unremarkable to wear in public, the test is a five-minute detour into the Settings menu, and the fitting happens without a referral or an appointment. For anyone who has quietly wondered whether their hearing has slipped, that's a dramatically lower first step.