The news
On August 11, 2026, Samsung Electronics (005930.KS) said the US Food and Drug Administration (FDA) had cleared its Galaxy Buds hearing aid feature, letting Galaxy Buds3 Pro and Buds4 Pro work as over-the-counter hearing aids for adults with perceived mild to moderate hearing loss.
The feature is for users 18 and older and requires no prescription or clinic visit, Samsung said. It will be available on the two earbud models in the US and select approved markets in the fourth quarter of 2026, and full support requires a compatible Galaxy device running One UI 9 or later. The Korea Herald reported that the FDA clearance applies only to the US market.
Setup starts with a five-minute Hearing Test in the Galaxy Buds settings menu, which Samsung says is registered as software as a medical device (SaMD), meaning software that performs a medical function on its own. It tests each ear with pure-tone audiometry, produces an audiogram and classifies hearing as normal or as mild, moderate, severe or profound loss. Samsung says the accuracy is comparable to an audiologist's evaluation.
The Hearing Aid feature then amplifies the sounds a user struggles to hear, such as high frequencies, whispers and distant voices, using NAL-NL2, a fitting formula widely used for prescription hearing aids. It adds noise elimination and beamforming, which focuses on sound in front of the wearer. Test results and noise-exposure data appear in the Samsung Health app.
Samsung developed the feature with the National Acoustic Laboratories and Samsung Medical Center, and said clinical validation studies were run at Vanderbilt University Medical Center, San Jose State University and the University of Memphis. Hon Pak, head of the Digital Health Team in Samsung's Mobile eXperience business, said the clearance means Samsung is "expanding access to hearing support."
Citing World Health Organization estimates, Samsung said more than 1.5 billion people have some degree of hearing loss, a figure projected to reach 2.5 billion by 2050, and that cost, stigma and limited access to care keep many from using hearing aids.
The numbers
- Eligible earbuds
- Galaxy Buds3 Pro, Galaxy Buds4 Pro
- Planned availability (US and select markets)
- Q4 2026
- Hearing Test length
- About 5 minutes
- Minimum user age
- 18
- People with some hearing loss worldwide (WHO, cited by Samsung)
- More than 1.5 billion
- US adults reporting some hearing loss (FDA, 2024)
- More than 30 million
Why CEOs should care
For HR and benefits leaders, hearing support is moving into devices employees already carry. Samsung has not announced pricing, but benefits teams can start asking how hearing care is covered today, whether wellness stipends or device programs could include hearing-capable earbuds, and how to explain that OTC devices are meant only for perceived mild to moderate loss, not a replacement for clinical care.
For IT and security teams, an earbud that is also a regulated medical device raises practical questions. Hearing test results are health data stored in Samsung Health, so ask how that data syncs, whether it crosses into managed work profiles and how mobile device management policies treat health apps. Accessibility and accommodation policies should also recognize that an employee's earbuds in a meeting or on a shop floor may be a hearing aid.
For product leaders and boards, the clearance shows regulated health features arriving on mass-market hardware through software updates. Companies in health care, insurance and consumer devices should plan for more of these features, with the compliance review, customer support and marketing-claims discipline that a medical device demands.
The bigger picture
The FDA created the OTC hearing aid category with regulations in October 2022, letting adults with perceived mild to moderate hearing loss buy hearing aids in stores or online without a medical exam, prescription or audiologist visit. In September 2024, the agency authorized Apple's (AAPL) Hearing Aid Feature for AirPods Pro through its De Novo pathway for novel devices, calling it the first OTC hearing aid software.
Samsung's clearance gives Galaxy users their own option and puts Samsung alongside Apple in turning earbuds into regulated hearing devices. It builds on a sound amplification feature Samsung added to Galaxy Buds+ in 2020.
What happened next
The Hearing Review reported on August 14, 2026, that Samsung had not announced pricing or a specific availability date beyond its fourth-quarter target, and the Korea Herald reported that Samsung had announced no plans for a South Korean rollout. Samsung's global newsroom listed no further hearing aid updates as of September 29.
The milestones to watch are the fourth-quarter rollout on Galaxy Buds3 Pro and Buds4 Pro, the timing of One UI 9 on compatible Galaxy devices, which additional markets approve the feature, and whether Samsung charges for it or ships it as a free update.
