Samsung Galaxy Buds 4 Pro and Galaxy Buds 3 Pro have received regulatory approval to function as over-the-counter (OTC) hearing aids — first in the US, now in South Korea. The US FDA cleared the feature in August 2026. South Korea’s Ministry of Food and Drug Safety granted its nod on November 4, 2026, enabling broader global rollout.
This is not a hardware revision. It’s software: two new modules, Hearing Test and Hearing Aid, turning existing earbuds into certified medical devices for adults 18 and older with mild to moderate hearing loss. No new model launched. No price change.
Just a functional upgrade, backed by clinical-grade audiometry and NAL-NL2 fitting algorithms used in professional hearing aids. The Hearing Test runs inside the Galaxy Buds app on Samsung Galaxy phones. It takes about five minutes, tests both ears, and delivers an audiogram, visual, comparable to what an audiologist produces, categorising hearing status as normal, mild, moderate, severe, or profound.
Results sync to Samsung Health. Once diagnosed, the earbuds switch into hearing aid mode: amplifying speech or vocals selectively, applying noise reduction, and using beamforming to focus sound directionally. That means clearer voices in noisy rooms, not just louder audio. The feature rolls out to US users in Q4 2026.
South Korea and other markets follow in early 2027. Samsung does not list pricing for the hearing aid functionality, it’s free, built into firmware updates for eligible models. Neither the Galaxy Buds 4 Pro nor the Buds 3 Pro are new: the 4 Pro launched in March 2026 at $249.99 in the US and Rs 22,990 in India.
The 3 Pro debuted in late 2025 at $199.99 and Rs 17,990. Apple’s AirPods Pro 2 and Pro 3 already offer similar OTC hearing aid features, approved earlier this year. Samsung’s move closes the gap, not on specs, but on medical utility. And it signals where true differentiation is heading: less about battery life or codec support, more about clinically validated health tools baked into everyday gear.
Firmware updates carrying Hearing Test and Hearing Aid begin shipping to US Galaxy Buds 4 Pro and 3 Pro owners this month.
GDFiled by The Gadgets Desk
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