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Samsung Galaxy Buds Hearing Aid Feature Gets FDA Clearance, to Roll Out in Q4 2026

Samsung Galaxy Buds Hearing Aid Feature Gets FDA Clearance, to Roll Out in Q4 2026

The Hearing Aid feature uses the audiogram to adjust amplification for each user.

Written by Sucharita Ganguly, Edited by Rohan Pal | Updated: 12 August 2026 11:32 IST

Samsung Galaxy Buds Hearing Aid Feature Gets FDA Clearance, to Roll Out in Q4 2026

Samsung will launch the features in Q4 2026

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Highlights

Galaxy Buds will offer a built-in hearing test for users
The new feature will support users with mild hearing loss
Samsung will add hearing aid support to select Galaxy Buds

Samsung has received US Food and Drug Administration (FDA) clearance for a new hearing aid feature for its Galaxy Buds. The feature will expand the earbuds' hearing health capabilities by offering sound amplification based on individual hearing needs. Samsung is also introducing a built-in hearing test to assess users' hearing and help personalise the experience. The company will bring these features to compatible Galaxy Buds models in the US and select approved markets later this year, adding hearing support to its wireless earbuds.

Samsung Galaxy Buds Get Hearing Aid Support After FDA Clearance

According to Samsung, the FDA clearance covers the company's Hearing Aid feature for users aged 18 and above with perceived mild to moderate hearing loss. It will allow compatible Galaxy Buds to provide over-the-counter hearing assistance without a prescription. Samsung notes that the feature is not a replacement for diagnosis or treatment from a qualified clinician.

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The Galaxy Buds hearing health system includes Hearing Test and Hearing Aid features, both accessible through the Buds menu in Settings without a separate app. The self-administered Hearing Test takes around five minutes and uses pure-tone audiometry to examine each ear individually. It generates an audiogram and places hearing ability into one of five categories: normal, mild, moderate, severe or profound hearing loss. Samsung has registered the test as Software as a Medical Device and says its results are comparable in accuracy to a professional audiologist's evaluation.

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The Hearing Aid feature uses the audiogram to adjust amplification for each user. It can boost sounds that may be difficult to hear, including higher frequencies, whispers and distant voices. Noise elimination and beamforming are also included, with beamforming helping focus on sounds in front of the wearer while reducing background noise. The system uses the NAL-NL2 fitting formula, which Samsung describes as a recognised clinical standard for prescription hearing aids.

Samsung developed the technology with the National Acoustic Laboratories and Samsung Medical Centre, and clinical studies were carried out at Vanderbilt University Medical Centre, San Jose State University and the University of Memphis, according to the press release. Users will also be able to view noise exposure levels and Hearing Test results in Samsung Health.

The South Korean tech giant first introduced hearing support on the Galaxy Buds+ in 2020 through a Personal Sound Amplification Product feature. The feature was clinically validated in 2021 to help people with hearing loss communicate in everyday situations.

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The FDA clearance makes Samsung one of the companies offering hearing aid features through wireless earbuds. Apple also offers a hearing test to adjust amplification and has expanded its hearing health features to more than 150 countries and regions.

The Hearing Aid and Hearing Test features will arrive on the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the US and select approved markets in Q4 2026. A compatible Galaxy device running One UI 8 or later is required, while availability may vary by market, model and paired device.

Samsung Galaxy Buds 3 Pro True Wireless Stereo (TWS) Earphones

KEY SPECS
NEWS

Colour Silver & Black

Headphone Type In-Ear

Microphone Yes

Connectivity True Wireless Stereo (TWS)

Type Earphones

More Samsung Headphones & Headset

Samsung Galaxy Buds 4 Pro True Wireless Stereo (TWS) Earphones

REVIEW
KEY SPECS
NEWS

Design / Comfort
Audio Quality
Battery Life
Value For Money

Good
Comfortable fit
Premium design
Robust, powerful sound
Good ANC
Decent battery life

Bad
No true multipoint support
Many features require a Samsung phone

Read detailed Samsung Galaxy Buds 4 Pro True Wireless Stereo (TWS) Earphones review

Colour Black

Headphone Type In-Ear

Microphone Yes

Connectivity True Wireless Stereo (TWS)

Type Earphones

More Samsung Headphones & Headset

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Further reading: Samsung, Samsung Galaxy Buds, Galaxy Buds, Galaxy Buds 3 Pro, Galaxy Buds 4 Pro, Samsung Hearing Aid, Hearing Aid, Hearing Test, FDA

Sucharita Ganguly

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Sucharita is a writer with Gadgets 360 and is mostly found playing with her cat in her free time. She has previously worked at breaking news desks across organizations. Powered by coffee, The Beatles, Bowie, and her newfound love for BTS, she aims to work towards contributing to a better media environment for women and queer folk. More