Hearing Technology
It is a cleared over-the-counter hearing aid feature for adults with mild to moderate hearing loss. That is a real development. A five-minute test, a fitting formula used by clinics, and amplification in earbuds many people already own lowers the barrier to trying hearing help.
It also raises fair questions: how good is it, who is it for, and when is an audiologist still the right call? This page answers those, with what Samsung has said, what independent outlets have reported, and what we would tell a patient in our San Mateo or San Carlos office.
At a glance
- The FDA cleared Samsung's Hearing Aid and Hearing Test features for Galaxy Buds3 Pro and Galaxy Buds4 Pro. Rollout is planned for Q4 2026 through a software update.
- It is for adults 18 and older with perceived mild to moderate hearing loss. Samsung says it is not a substitute for professional diagnosis or treatment.
- It uses NAL-NL2, a fitting formula used in prescription hearing aids. The five-minute test is self-administered, and the results do not replace a full hearing evaluation.
- Sudden hearing loss, loss in one ear, dizziness, ear pain, or severe to profound loss need a professional evaluation, not an app.
What Samsung just got cleared to do
Samsung received FDA clearance for two features in the Galaxy Buds app. The first is a Hearing Test, registered as Software as a Medical Device. It is a self-administered test that takes about five minutes and uses pure-tone audiometry, tested one ear at a time, to produce an audiogram. The second is the Hearing Aid feature, which amplifies sound according to your results. It was cleared through the FDA's over-the-counter pathway, the same category as OTC hearing aids sold in stores.
How it works
You take the test in the app with the earbuds in. The app sorts the result into normal or one of four stages of loss, from mild to profound, and builds an audiogram. The amplification then uses NAL-NL2, a fitting formula from Australia's National Acoustic Laboratories that clinics widely use to set prescription hearing aids. The system also includes beamforming microphones that favor sound in front of you and noise reduction aimed at speech. Wareable reports that the audiogram is stored in the Samsung Health app.
What the published numbers say
audioXpress, citing Samsung's data, reports a maximum output of about 111.9 dB SPL, full-on gain of about 31.5 dB, a frequency range of roughly 100 Hz to 9,000 Hz, and a delay of about 2.7 milliseconds. A 30-day study of 103 adults with mild to moderate loss found that people who fit the feature themselves reported benefit that was not worse than people fitted by a clinician. A separate validation of 367 participants found the app's test differed from clinic audiometry by a median of 3.75 dB. These are encouraging, and they come from Samsung's own submission and are reported second-hand. Independent lab testing had not been published as of this writing.
What you need
You need Galaxy Buds3 Pro or Galaxy Buds4 Pro, a compatible Galaxy phone and the software update. Samsung's own announcement says One UI 9 or later. Some outlets have reported One UI 8, so check Samsung's footnote for your region before you buy or update. Samsung adds that availability can vary by market, model and paired device. The feature does not apply to older Buds models.
The audiologist's take: what it does well
Three things stand out. It gets more people to take a hearing test, which matters because many adults wait years. It uses a real clinical fitting formula and not a generic boost. And it lives in a device that people already wear, which makes it easier to use often. For someone with mild to moderate loss who mainly wants help in conversation, it may work well.
Where OTC earbuds reach their limits
A five-minute test in a living room is not a full evaluation. It cannot rule out wax, a middle-ear problem, or a difference between the ears that needs a doctor. The amplification has a ceiling. In our reading, a full-on gain near 31.5 dB suggests that people near the top of the moderate range may run out of power in some pitches. Earbud tips can block the ear canal, which can change how your own voice sounds. And there is no verification of the real sound reaching your eardrum, no one to adjust it after you leave the store, and no repair plan. Recent research on earbud hearing features, as summarized by HearingTracker, found that actual gain can fall below the fitting targets.
OTC earbuds compared with prescription hearing aids
Who it suits: earbuds are for adults with perceived mild to moderate loss, while prescription hearing aids cover mild through profound loss, including single-sided loss and complex cases. How it is fitted: earbuds are self-fitted from an in-app test, while prescription aids are programmed from a full evaluation and verified with real-ear measurement. Follow-up: earbuds leave you to adjust on your own, while a clinic provides fine-tuning, cleaning and repairs. Extras: earbuds play music and take calls and, in the Buds4 line, add Bluetooth LE Audio and Auracast, per audioXpress. Hearing aids are built to be worn all day. Neither is better for everyone. The right one depends on your hearing. See our guide to OTC and prescription hearing aids.
How it compares with AirPods Pro
Apple's AirPods Pro hearing aid feature received FDA authorization in September 2024, and it follows a similar design: a hearing test, a self-fit, and amplification in the earbuds. Samsung brings this to Android. Reports suggest both can help mild to moderate loss. We have not seen head-to-head independent testing, so we cannot say which sounds better. The better choice is usually the one that matches your phone.
When you should still get a professional evaluation
Get tested first, and do not rely on the app, if you have sudden hearing loss, loss that is much worse in one ear, dizziness, ear pain or drainage, ringing in one ear only, trouble understanding words even when they are loud, or a family history that worries you. See a professional also if you already struggle in quiet rooms. Those can signal loss beyond what an OTC device is built for. A hearing evaluation takes under an hour, and the results help whichever device you choose.
Does Medicare pay for this?
Original Medicare generally does not cover hearing aids, and OTC earbuds are not covered either. Some Medicare Advantage plans include a hearing allowance or an OTC benefit, and the rules differ by plan. Open enrollment is coming, so read our page on Medicare open enrollment and hearing benefits.
Status and last update
Last updated September 30, 2026. What changed: this is the first version of the page. We will update it when Samsung's rollout goes live or independent testing is published. Sources: Samsung's announcement, Wareable, HearingTracker, audioXpress and eWeek.
Medical information notice
This page is for general information only. It is not medical advice. Earbud prices are product prices, not the cost of hearing care. If you are unsure whether an OTC device is enough for you, book a hearing evaluation.
Frequently asked questions
Your questions, answered
Which Galaxy Buds work as hearing aids?
Only the Galaxy Buds3 Pro and Galaxy Buds4 Pro, once the software update arrives. You also need a compatible Galaxy phone. Samsung's announcement says One UI 9 or later.
When is the hearing aid update coming out?
Samsung says the fourth quarter of 2026 in the United States and some other approved markets. As of September 30, 2026, we have not seen confirmation that it is live.
How does it compare to AirPods Pro hearing features?
Both use a self-administered hearing test and amplify sound in the earbuds for adults with mild to moderate loss. Apple's feature was authorized in September 2024. We have not seen independent head-to-head testing, so the best choice is usually the one that works with your phone.
Can earbuds replace my hearing aids?
For mild loss, they may be enough. For moderate to profound loss, loss in one ear, or complex hearing needs, prescription hearing aids are built and verified for the job. If you already wear hearing aids and they work, do not swap them for earbuds without talking to us.
Do I still need an audiologist?
Often, yes. A hearing evaluation can rule out wax or a medical cause and checks your hearing more fully than a five-minute app test. It also gives you a baseline and tells you whether an OTC device is enough for you.