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Samsung Says Galaxy Buds Hearing Aid Feature Cleared by FDA
Samsung says compatible Galaxy Buds will offer an over-the-counter hearing aid feature in the U.S. and selected markets from Q4 2026.
Samsung says its Galaxy Buds Hearing Aid feature has received clearance from the U.S. Food and Drug Administration, opening the way for compatible earbuds to serve as over-the-counter hearing aids. The company announced the regulatory milestone on August 11, while stating that the feature will become available in the United States and selected approved markets during the fourth quarter of 2026.
The announcement concerns adults aged 18 and over with perceived mild to moderate hearing loss. Samsung describes the feature as a way to access hearing support without a prescription or a clinic visit. That does not make the earbuds a replacement for professional care: availability, eligibility and performance will depend on the market, device model and paired Galaxy phone.
The FDA’s guidance on over-the-counter hearing aids explains that this category is intended for adults with perceived mild to moderate hearing loss. It also makes clear that a self-fitting product is different from a prescription hearing aid, which can be selected and programmed by a hearing-care professional.
What Samsung is adding to Galaxy Buds
The experience is built around two features: Hearing Test and Hearing Aid. According to Samsung’s announcement, users will be able to complete a self-administered hearing test from the Galaxy Buds menu in Settings. The test takes about five minutes and uses pure-tone audiometry to assess each ear separately.
Samsung says the software creates an audiogram and classifies hearing as normal or within one of four stages: mild, moderate, severe or profound. The company describes the results as medical-grade, but the announcement does not present an independent clinical report or detailed test data. That distinction matters: the feature may help users identify a potential issue, but a software-generated result should not be treated as a complete medical diagnosis.
Once a hearing profile has been created, the Hearing Aid feature is designed to amplify sounds that a user may have difficulty hearing. Samsung specifically mentions higher frequencies, whispers and distant voices. It also says the feature includes noise elimination and beamforming, intended to reduce unwanted background sound and focus on voices in front of the wearer.
Samsung says the system uses NAL-NL2, a fitting formula used in hearing-aid technology, to personalize amplification for each user. The company also points to development work with the National Acoustic Laboratories, Samsung Medical Center and researchers at Vanderbilt University Medical Center, San Jose State University and the University of Memphis. The announcement gives no detailed results from those studies, so the regulatory clearance should not be confused with an independent product test.
Compatible devices and software requirements
The feature will not be available across the entire Galaxy Buds range. Samsung lists Galaxy Buds3 Pro and Galaxy Buds4 Pro as the compatible models. Full support also requires a compatible Galaxy device running One UI 8 or later.
Samsung says users will not need a separate application to access the Hearing Test and Hearing Aid controls. The features are integrated into the Galaxy Buds section of the phone’s Settings menu. Hearing-related information, including noise-exposure levels and hearing-test results, will also be available through Samsung Health.
This integration places the feature between a traditional accessory setting and a mobile health service. The earbuds collect the audio experience, the phone provides the controls and Samsung Health becomes the place where users can review related information. That could make hearing support easier to discover for existing Galaxy owners, although it also ties the experience to Samsung’s hardware and software ecosystem.
Availability will begin later this year
Samsung has not announced a precise release date, price or complete market list. Its current statement only says that the Hearing Aid and Hearing Test features are planned for Q4 2026 in the U.S. and selected approved markets. Availability may vary by country, device model and paired phone, and the company has not said whether the feature will arrive through a firmware update, a phone software update or both.
For now, the announcement is a regulatory and accessibility milestone rather than an immediate product rollout. Owners of compatible Galaxy Buds should wait for Samsung to publish local availability details and supported-device information before assuming that the feature will work in their region.
There is also an important safety boundary. Samsung states that the Hearing Aid feature is intended for adults with perceived mild to moderate hearing loss and is not a substitute for professional diagnosis or treatment. Anyone concerned about hearing changes should consider speaking with a qualified clinician, particularly if symptoms are sudden, worsening or accompanied by other health concerns. The FDA also provides separate guidance on when consumers should seek professional advice.
Samsung’s move shows how smartphone ecosystems are becoming gateways to more accessible health features. The practical value of this announcement will depend on the quality of the hearing assessment, the clarity of the rollout and the safeguards surrounding use. Until the Q4 launch, the confirmed facts are limited to the FDA clearance announced by Samsung, the two compatible Galaxy Buds models and the planned availability in the U.S. and selected markets.