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Fierce Biotech·20h ago·1 min read
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Samsung gets FDA clearance for Galaxy Buds hearing-aid features

Aug 12, 2026·read at Fierce Biotech ↗ApprovalPositive

Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests.

The hearing test is classified as software for a medical device and provides medical‑grade results, according to an August 11 press release. The test runs within the Buds’ settings menu and takes about five minutes.

Samsung says the integrated solution expands access to hearing support, noting that more than 1.5 billion people worldwide have some hearing loss, a figure projected to rise to 2.5 billion by 2050.

The features are built into the earbuds and do not require a separate app, allowing users to navigate the test and hearing‑aid functions directly from the device.

source

This writeup was produced by pharmadog from original reporting by Fierce Biotech.

Original headline: “Samsung hearing aid features for its ear buds garner FDA clearance”

read at Fierce Biotech ↗
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