Samsung Galaxy Buds get FDA clearance for OTC hearing aid feature
Samsung's Galaxy Buds Pro 3 and Pro 4 will soon offer at-home hearing tests and sound amplification, launching in Q4 2026.
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Summary, timeline and people extracted by Claude from 23 items across 3 sources · 5h ago. Quotes are verbatim.
Samsung announced today that the FDA has cleared its Galaxy Buds Hearing Aid feature, which enables the earbuds to function as over-the-counter hearing aids for users 18 and older with mild to moderate hearing loss. The feature includes a five-minute at-home hearing test and personalized sound amplification, rolling out in the US and select markets starting in Q4 2026. This expands Samsung's hearing health offerings and provides a lower-cost alternative to prescription hearing aids, which can cost thousands of dollars.
- Samsung's Galaxy Buds Pro 3 and Pro 4 have received FDA clearance to function as over-the-counter hearing aids, competing with Apple's AirPods Pro offering.
- The feature includes a clinical-grade five-minute hearing test and personalized sound amplification, available in Q4 2026 on devices with One UI 8 or later.
- OTC hearing aids address a massive health gap: 1.5+ billion people globally experience hearing loss, but many avoid treatment due to cost and access barriers—Samsung's solution is a lower-cost alternative to prescription aids costing thousands.
- Samsung has validated the technology through partnerships with National Acoustic Laboratories and clinical studies at Vanderbilt, San Jose State, and University of Memphis.
How it unfolded
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Samsung Electronics announced that the Galaxy Buds Hearing Aid feature has received FDA clearance, enabling Galaxy Buds Pro 3 and Pro 4 to serve as over-the-counter hearing aids.
“Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world.”
Hon Pak, Senior Vice President, Samsung Electronics Digital Health Team · Google News ↗ -
The Galaxy Buds Hearing Test is a five-minute, clinical-grade audiometry tool that generates results comparable to professional audiologist evaluations. The Hearing Aid feature then personalizes sound amplification based on individual hearing profiles, including noise elimination and beamforming.
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Prescription hearing aids can cost thousands of dollars out of pocket. Samsung's OTC solution addresses a major health gap: the WHO estimates over 1.5 billion people globally experience hearing loss, with the figure projected to reach 2.5 billion by 2050, yet many avoid hearing aids due to cost, stigma, or limited access.
“Samsung cautions its Hearing Aid feature "is not a substitute for professional diagnosis or treatment by a qualified clinician."”
Samsung · Google News ↗ -
The hearing aid feature will be available in the US and select approved markets starting in Q4 2026 (after September 30). Full support requires a compatible Galaxy device with One UI 8 or later, with features living in the Samsung Health app.
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Apple already offers similar hearing test and OTC hearing aid functionality through AirPods Pro 2 and AirPods Pro 3. Samsung's approach mirrors Apple's, integrating the features directly into the earbuds without requiring a separate app.
What people are saying verbatim
“Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world.”
Hon Pak, Senior Vice President, Samsung Electronics, Head of Digital Health Team · Samsung press release ↗ · Aug 10
“Samsung cautions its Hearing Aid feature "is not a substitute for professional diagnosis or treatment by a qualified clinician."”
Samsung, Product maker · Android Authority ↗ · Aug 10
“Hearing loss is incredibly common, yet it remains one of the most overlooked health conditions worldwide.”
Samsung Electronics, Product maker · Samsung press release ↗ · Aug 10
“Hearing intervention can be pricey, especially if you're paying out of pocket — prescription hearing aids can cost thousands of dollars.”
Android Authority, Tech publication · Android Authority ↗ · Aug 10
“Users can also diagnose their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.”
Samsung, Product maker · Samsung press release ↗ · Aug 10
“By navigating to the Galaxy Buds menu in Settings, users can complete a self-administered Hearing Test in just five minutes.”
Samsung, Product maker · Samsung press release ↗ · Aug 10