Samsung Turns Galaxy Buds3 Pro Into FDA-Cleared Hearing Aids
The feature uses hearing tests and personalized amplification to help adults with mild to moderate hearing loss, Samsung said.
- Samsung received Food and Drug Administration clearance for a hearing aid feature, allowing compatible Galaxy Buds to function as over-the-counter devices for adults with mild to moderate hearing loss.
- Aiming to assist the more than 1.5 billion people worldwide experiencing hearing loss, the system combines a five-minute Hearing Test with an amplification feature to boost difficult sounds like distant voices and surrounding whispers.
- The features will arrive in Q4 2026 on Galaxy Buds3 Pro and Galaxy Buds4 Pro, requiring a compatible Galaxy device with One UI 8 and utilizing the NAL-NL2 clinical standard for personalization.
- These features reside in the Samsung Health app, providing "hearing-related insights," though Samsung cautions the tool is not a substitute for professional diagnosis and users with pronounced loss should consult an audiologist.
- This development positions Samsung to compete directly with Apple, which offers similar capabilities on its AirPods Pro, building on the company's years of work in personal sound amplification.
15 Articles
15 Articles
Samsung turns Galaxy Buds3 Pro into FDA-cleared hearing aids
Samsung has received FDA clearance for a Hearing Aid feature that will let the Galaxy Buds3 Pro and Galaxy Buds4 Pro function as over-the-counter hearing aids. It is designed for adults with perceived mild to moderate hearing loss, with the first rollout planned for the US and selected approved markets in Q4 2026. The hearing test tunes each ear separately The Hearing Test and Hearing Aid features are accessed through the Galaxy Buds menu in Set…
Samsung Galaxy Buds Gain FDA Nod as Hearing Aids, Opening New Chapter in Consumer Audio Health
Samsung just cleared a significant regulatory bar. Its Galaxy Buds Hearing Aid feature received clearance from the U.S. Food and Drug Administration. The development turns select premium earbuds into over-the-counter tools for adults facing mild to moderate hearing challenges. No prescription needed. No clinic visit required. The announcement landed today from Samsung Electronics. It pairs the new capability with a Hearing Test already positione…
FDA approves Samsung's Hearing Aid feature on Galaxy Buds
Samsung has been improving its health-tracking features and the recent FDA approval for the Galaxy Buds' Hearing Aid feature adds another such feature to its toolbox. The US Food and Drug Administration cleared the Hearing Aid feature as an over-the-counter (OTC) solution for users aged 18 and above. It makes some Galaxy Buds models a convenient alternative to some expensive hearing aid devices for people with mild to moderate hearing loss. For …
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