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Samsung’s Galaxy Buds Get FDA‑Cleared Hearing Aid by 2026

MacRumors •
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Samsung today announced its Galaxy Buds Hearing Aid feature cleared by the FDA, bringing clinical‑grade hearing aid capabilities to the buds in the fourth quarter of 2026.

The move lets Samsung join Apple in offering over‑the‑counter hearing aid functionality, following Apple’s 2024 FDA‑cleared feature for AirPods. Like the AirPods, the Galaxy Buds can replace a hearing aid for mild to moderate loss, and Samsung introduces a five‑minute self‑administered hearing test that generates a clinical‑grade audiogram to fine‑tune the built‑in aid.

The buds amplify hard‑to‑hear sounds—high frequencies or whispers—using noise elimination and beamforming to focus on front sounds while suppressing background noise. Development involved the National Acoustic Laboratories and Samsung Medical Center. Hearing‑aid features will ship on the Galaxy Buds3 Pro and the Galaxy Buds4 Pro, requiring a newer Samsung Galaxy phone with One UI 8 or later. Apple has expanded availability to over 150 countries after its iOS 18.1 launch, giving Samsung a catching‑up opportunity with a comparable hearing‑health option.