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Samsung’s Galaxy Buds get FDA‑cleared hearing aid

Engadget •
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The Food and Drug Administration cleared Samsung’s new hearing‑aid function for Galaxy Buds, putting the company on par with Apple’s AirPods Pro. The feature, coming to Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the US and other markets later this year, offers an over‑the‑counter aid for adults 18 + with mild‑to‑moderate hearing loss. A built‑in hearing test can deliver medical‑grade results in just five minutes; users start it in the Buds’ settings on a compatible Galaxy phone. For each ear the test flags whether hearing is normal or labels loss as mild, moderate, severe or profound. The results, visible in the Samsung Health app, allow the Buds to amplify sounds the wearer struggles with—whispers, distant voices and high frequencies—while also working with noise‑cancellation and beam‑forming to focus on front‑of‑wearer audio.

Samsung says the FDA clearance means the company can market the aid as an over‑the‑counter device, offering a convenient alternative for users who would otherwise seek a prescription. The Buds’ adaptive amplification works in tandem with the earbuds’ noise‑elimination and beam‑forming capabilities, sharpening speech from the front while filtering background noise. The hearing test uses frequency‑specific tones to evaluate thresholds, and the five‑minute assessment delivers a comprehensive profile that the user can review in the Samsung Health app. Once the loss level is identified, the Buds automatically adjust volume levels for each ear to compensate without the need for manual tuning.