Samsung Galaxy Buds Hearing Aid Feature: FDA Cleared, Which Buds, and When It Arrives
Samsung’s Galaxy Buds can now work as an FDA cleared over the counter hearing aid, putting the same kind of feature Apple added to AirPods Pro in 2024 into Android users’ ears.
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Quick answer, verified October 20, 2026
Samsung announced on August 11, 2026, that the FDA cleared its Galaxy Buds Hearing Aid feature. It turns compatible Galaxy Buds into an over the counter hearing aid for adults 18 and older with perceived mild to moderate hearing loss, with no prescription or clinic visit. Samsung plans to start rolling it out in the fourth quarter of 2026.
- Which Buds: Galaxy Buds3 Pro and Galaxy Buds4 Pro at launch.
- Phone: requires a compatible Galaxy smartphone running One UI 8 or later.
- Hearing test: a five minute self test in Settings, registered as Software as a Medical Device, that produces an audiogram.
- Fitting: amplification is personalized with NAL NL2, a standard clinical fitting formula.
- Extra cost: it is a software feature on supported Buds; Samsung has not announced a separate fee.
The short verdict
Over the counter hearing aids have been legal in the US since 2022, but the biggest change in access has come from earbuds people already own. Apple’s AirPods Pro hearing aid feature, authorized in September 2024, was the first OTC hearing aid software. Samsung’s clearance brings a comparable option to Galaxy phone owners, built into the Galaxy Buds settings rather than a separate app.
For someone with mild to moderate hearing loss who already owns or was planning to buy Galaxy Buds3 Pro or Buds4 Pro, this is a low friction first step. It is not a substitute for a full hearing evaluation if you have sudden hearing loss, pain, drainage, ringing in one ear, or severe loss.
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How the Galaxy Buds hearing aid feature works
Samsung’s hearing health setup has two parts, both reached from the Galaxy Buds menu in the phone’s Settings.
- Hearing Test: a self administered test that takes about five minutes. It uses pure tone audiometry, tests each ear separately, and produces an audiogram. Samsung says results classify hearing as normal or as mild, moderate, severe or profound loss, with accuracy comparable to a professional evaluation.
- Hearing Aid: based on the test, the earbuds amplify the sounds you struggle to hear, such as high frequencies, whispers and distant voices, tuned to your profile using the NAL NL2 fitting formula.
Samsung developed the feature with the National Acoustic Laboratories and Samsung Medical Center, with validation studies at Vanderbilt University Medical Center, San Jose State University and the University of Memphis. It builds on a sound amplification feature Samsung first added to Galaxy Buds+ in 2020.
Which Galaxy Buds and phones are supported
At launch, the hearing aid feature supports the Galaxy Buds3 Pro and Galaxy Buds4 Pro, paired with a compatible Galaxy smartphone running One UI 8 or later. Samsung plans to begin the rollout in the fourth quarter of 2026 in approved markets. Other Galaxy Buds models, including the lower cost Buds3 FE, are not on the launch list.
Who it is for
- Adults 18 and older who notice trouble following conversations, especially in noisy places.
- People with perceived mild to moderate hearing loss who have been putting off traditional hearing aids because of cost, stigma or access.
- Galaxy phone owners who already use Buds3 Pro or Buds4 Pro and want to try amplification before spending more.
It is not intended for children, for severe or profound hearing loss, or for anyone with warning signs such as sudden or one sided hearing loss, ear pain or drainage. Those need an in person evaluation.
Galaxy Buds vs AirPods Pro vs traditional OTC hearing aids
- AirPods Pro: Apple’s hearing aid feature, authorized in September 2024, works on compatible AirPods Pro with an iPhone. Samsung’s feature is the Android counterpart for Galaxy users.
- Dedicated OTC hearing aids: smaller, designed for all day wear, and usually with longer battery life, but without the music and call features of mainstream earbuds.
- Prescription hearing aids: fitted by an audiologist, appropriate for more severe or complex hearing loss.
Limitations and open questions
- Battery and comfort: earbuds are not designed to be worn every waking hour the way dedicated hearing aids are.
- Ecosystem lock in: the feature requires a Galaxy phone; it does not work with other Android phones or iPhones.
- Real world performance: independent testing after launch will show how well it handles restaurants and other noisy settings.
- Rollout timing: availability depends on the Q4 2026 update reaching your phone and region.
Frequently asked questions
Can Galaxy Buds be used as hearing aids?
Yes. The FDA cleared Samsung’s Galaxy Buds Hearing Aid feature, announced August 11, 2026. It lets Galaxy Buds3 Pro and Buds4 Pro work as over the counter hearing aids for adults with perceived mild to moderate hearing loss.
When will the Galaxy Buds hearing aid feature be available?
Samsung plans to start rolling it out in the fourth quarter of 2026, for compatible Galaxy smartphones running One UI 8 or later.
Which Galaxy Buds support the hearing aid feature?
Galaxy Buds3 Pro and Galaxy Buds4 Pro at launch.
Do I need a prescription?
No. It is an over the counter hearing aid feature for adults 18 and older. You run the built in hearing test yourself.
Sources
- Samsung Mobile Press: Hearing Aid feature on Galaxy Buds cleared by FDA (August 11, 2026)
- The Hearing Review (August 14, 2026)
- eWeek: Galaxy Buds get FDA clearance to work as hearing aids
This article is for general information and is not medical advice. See a clinician for sudden, one sided or severe hearing loss.
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