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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.
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Samsung Galaxy Buds Gain Hearing Aid Feature Following FDA Clearance – channelnews

Samsung is expanding the health-focused capabilities of its premium Galaxy Buds, with selected models set to gain hearing assistance technology designed for adults experiencing mild to moderate hearing loss. The feature has received clearance from the US Food and Drug Administration and is expected to roll out later this year alongside a new hearing test that can be completed using compatible Galaxy devices. Samsung plans to introduce the functionality to the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro in the United States and selected international markets. The update will allow the wireless earbuds to provide over-the-counter hearing assistance for adults aged 18 and older. The move puts Samsung into closer competition with Apple, which already offers similar hearing assistance capabilities through compatible AirPods Pro models. A key part of Samsung’s system is a hearing test integrated into the Galaxy Buds settings on compatible Galaxy smartphones. The company says users will be able to complete the assessment in approximately five minutes and receive what it describes as medical-grade results. Each ear is assessed separately during the test. The system can determine whether a user’s hearing falls within a normal range or indicates mild, moderate, severe or profound hearing loss. Results will also be accessible through the Samsung Health app, giving users a central location to review their hearing information. For adults identified as having mild or moderate hearing loss, the Galaxy Buds can use the test results to personalise amplification according to individual hearing requirements. The technology is intended to make quieter or more difficult sounds easier to distinguish, including whispers, distant conversations and sounds at higher frequencies. Samsung is combining the hearing assistance functionality with audio processing technology already incorporated into its earbuds. Noise elimination is used to reduce unwanted background sounds, while beam-forming technology concentrates on audio coming from directly in front of the wearer. Together, these technologies are intended to improve the clarity of conversations and other everyday sounds. The approach could make Galaxy Buds more useful beyond entertainment and phone calls, particularly for people who require some hearing assistance but do not necessarily need a dedicated hearing aid. Samsung is positioning the technology specifically for adults with mild to moderate hearing loss. It is not intended as a replacement for professional hearing care or dedicated hearing devices for people with more significant hearing impairment. FDA clearance represents an important step towards bringing the feature to consumers and places Samsung’s premium earbuds more directly against Apple’s AirPods Pro in the growing market for consumer audio devices with hearing health capabilities. Samsung has yet to confirm a specific launch date. The hearing test and hearing aid functionality are scheduled to arrive on the Galaxy Buds 3 Pro and Galaxy Buds 4 Pro later this year in the US and selected additional markets.

Lean Right

After Apple's opening the way with AirPods Pro 2, it's now Samsung's turn to advance to hearing health. South Korean company advances with technology in the Galaxy Buds that approaches the...

·Lisboa, Portugal
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Android Headlines broke the news on Tuesday, August 11, 2026.
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