Samsung's everyday earbuds are about to double as medical devices. The US Food and Drug Administration (FDA) has cleared Samsung's Hearing Aid feature for Galaxy Buds, the company announced on August 11 — turning the Galaxy Buds3 Pro and Galaxy Buds4 Pro into over-the-counter (OTC) hearing aids for adults aged 18 and up with perceived mild to moderate hearing loss, no prescription or clinic visit required.
How the Hearing Aid feature works
Once enabled, the feature amplifies the specific sounds a user struggles to hear — high frequencies, nearby whispers, and distant voices — rather than simply making everything louder. It pairs that amplification with noise elimination and beamforming, a microphone technique that focuses on sound coming from the direction the wearer is facing while suppressing background noise.
The personalization is built on NAL-NL2, a globally recognized clinical fitting formula used by professional audiologists to prescribe how much amplification each frequency should get for a given hearing profile. In other words, the tuning method is the same class of science used in dedicated hearing aids, applied to consumer earbuds.
A five-minute test with clinical-grade results
The companion Hearing Test feature, cleared alongside it, is registered as Software as a Medical Device (SaMD) — software that performs a medical function on its own. The self-administered test takes about five minutes from the Galaxy Buds menu in Settings, uses clinical-grade pure-tone audiometry to check each ear individually, and produces an audiogram — a chart of hearing ability across frequencies — comparable to a professional evaluation. Results are sorted into five levels, from normal through mild, moderate, severe, or profound hearing loss, and the Hearing Aid feature then tunes itself to that audiogram.
According to Samsung Mobile Press, the features were clinically validated with Vanderbilt University Medical Center, San Jose State University, and the University of Memphis, building on hearing-assistance work Samsung first validated on the Galaxy Buds+ back in 2021.
"Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world," said Hon Pak, Senior Vice President and Head of the Digital Health Team at Samsung Electronics.
When and where it arrives
The Hearing Aid and Hearing Test features roll out in Q4 2026 on the Galaxy Buds3 Pro and Galaxy Buds4 Pro, in the US and what Samsung calls "select approved markets." GSMArena notes that future Galaxy Buds Pro models are expected to carry the feature as well.
Will it reach Filipino Galaxy Buds owners?
The hardware is already here: the Galaxy Buds3 Pro is officially sold in the Philippines through Samsung's local online store. The feature is a different matter — Samsung has not named its "select approved markets," and hearing-aid functions are regulated medical features that typically need country-by-country clearance before they can be switched on. As of publication, there is no confirmation that the Hearing Aid feature will be available in the Philippines, so local Buds3 Pro owners should treat Q4 2026 as a US-first date and watch for a local announcement.
If it does arrive, the appeal is real: OTC hearing assistance built into earbuds people already own and wear without stigma, plus a free five-minute hearing check that could push more people to take early hearing loss seriously — a category where dedicated devices remain expensive and clinic visits remain a barrier.
