Samsung Galaxy Buds hearing aid feature gets US FDA clearance

Samsung has received clearance from the US Food and Drug Administration (FDA) for a hearing aid feature on its Galaxy Buds, marking the company's entry into the over-the-counter assistive audio space. The approval, confirmed on Tuesday, will allow select Galaxy Buds models to function as hearing aids for people with mild to moderate hearing loss.

The move comes nearly two years after Apple introduced a similar capability on its AirPods Pro, which received FDA authorisation in September 2024. With this clearance, Samsung is now poised to offer Android users an equivalent feature, potentially expanding the market for accessible hearing assistance.

What the FDA clearance means

The FDA's nod permits Samsung to market the Galaxy Buds as over-the-counter (OTC) hearing aids, a category established by the US regulator in 2022 to make hearing support more affordable and accessible. Unlike prescription hearing aids, OTC devices do not require a medical exam or fitting by an audiologist, which can cost thousands of rupees.

Samsung has not yet disclosed which specific Galaxy Buds models will support the feature, but the company said it will roll out the functionality in the US starting this year. The feature is expected to include a hearing test that calibrates the buds to the user's hearing profile, similar to Apple's approach.

How it will work

Users will likely access the hearing aid function through Samsung's Galaxy Wearable app, which will administer a clinically validated hearing test. Based on the results, the buds will amplify sounds in real time, boosting frequencies where the user shows deficits while preserving clarity in others.

The software-driven approach means existing Galaxy Buds owners may receive the feature via a firmware update, rather than needing to purchase new hardware. Samsung has not confirmed the update schedule or which models are eligible, but industry watchers expect the Galaxy Buds3 Pro and newer models to be among the first.

Competitive pressure and market context

Samsung's clearance arrives as the hearing aid market undergoes rapid disruption. Apple's AirPods Pro feature, launched with iOS 18, has been widely praised for making hearing assistance mainstream, and analysts estimate it has already shifted consumer expectations. PhoneArena noted that this has long been "one of the best AirPods Pro features," and its arrival on Galaxy Buds could level the playing field for Android users.

India Today reported that Samsung will bring the feature to Galaxy Buds starting this year, though a timeline for India has not been announced. The Indian market, where hearing loss affects an estimated 6-8 crore people, could benefit significantly if the feature is introduced locally, especially given the high cost of traditional hearing aids.

What to watch

Samsung is expected to share more details about the hearing aid feature's rollout during its next Unpacked event, likely in the coming months. The company will need to navigate regulatory approvals in other countries, including India, where medical device rules differ. For now, US users on Galaxy devices can look forward to an affordable, software-powered hearing aid option that challenges the status quo.