Samsung has secured US Food and Drug Administration clearance for hearing aid and hearing test software on its Galaxy Buds3 Pro and Galaxy Buds4 Pro wireless earbuds. Scheduled for a fourth-quarter release, the update makes Samsung the second consumer electronics maker after Apple to enter the regulated over-the-counter hearing market.
Wireless earbuds are officially stepping into the medical device aisle. Samsung announced that its Galaxy Buds lineup has cleared regulatory hurdles with the US Food and Drug Administration, paving the way for everyday hardware to double as clinical-grade medical equipment. The green light applies specifically to the Galaxy Buds3 Pro and Galaxy Buds4 Pro, bringing self-fitting over-the-counter hearing assistance to adult users.
How the Five-Minute Hearing Test and Custom Amplification Work
The newly cleared system operates through a two-part software suite built directly into the device settings and paired with the Samsung Health app. Users aged 18 and older experiencing perceived mild-to-moderate hearing loss can initiate a self-administered assessment without a doctor’s prescription or a clinic visit.
The diagnostic phase relies on pure-tone audiometry. Registered as Software as a Medical Device, the tool plays tones across varying frequencies and volumes for each ear independently over a five-minute span. Once completed, the software generates an audiogram categorizing the user’s hearing as normal or falling into one of four stages: mild, moderate, severe, or profound.
For those with mild-to-moderate impairment, the Hearing Aid feature utilizes personal profile data to calibrate sound output. Rather than a flat volume boost, the software applies the NAL-NL2 fitting formula—a globally recognized standard used in professional prescription hardware—to selectively enhance frequencies that wearers typically struggle to perceive, including high frequencies, whispers, and distant voices.
To maintain speech intelligibility in chaotic environments, the system incorporates multi-microphone beamforming alongside active noise cancellation. All diagnostic metrics, noise exposure data, and hearing test results sync continuously to the user’s mobile wellness profile.
Clinical Groundwork and the Competitive Landscape With Apple
Samsung’s regulatory milestone does not arrive in a vacuum. The company first introduced sound amplification tools on the Galaxy Buds+ in 2020 before pursuing formal clinical validation. Over the intervening years, the company collaborated with the National Acoustic Laboratories and Samsung Medical Center, conducting validation studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis.
The timing positions Samsung to challenge Apple in the consumer hearing health space. Apple secured FDA clearance for similar software on its AirPods Pro line back in 2024, gradually expanding its footprint to more than 150 countries. While Apple held a multi-year head start, Samsung’s integration closes the gap by matching core diagnostic and personal sound-boosting features.
The World Health Organization estimates that more than 1.5 billion people live with hearing loss worldwide—a figure projected to hit 2.5 billion by 2050. Despite the widespread need, adoption rates remain low due to high equipment costs, social stigma, and restricted access to professional audiologists.
Hardware Limitations and the Fourth-Quarter Rollout
Despite the regulatory clearance, consumer-grade hearables carry inherent physical boundaries. Battery longevity remains a central constraint; both the Galaxy Buds3 Pro and Galaxy Buds4 Pro are rated for roughly seven hours of continuous use when active noise cancellation is disabled. For users requiring constant medical amplification throughout an entire day, standard wireless earbuds may require periodic recharging breaks.
Furthermore, the software update is not universally accessible across older ecosystems. Operating the medical-grade processing requires a connected Samsung smartphone running One UI 8 or later.
Medical professionals and manufacturers emphasize that the over-the-counter category has strict boundaries. Regulatory guidelines explicitly state that these devices are not intended for severe or profound hearing loss.
“is not a substitute for professional diagnosis or treatment by a qualified clinician.”
Samsung, via PCMag
Samsung plans to begin rolling out both the Hearing Test and Hearing Aid capabilities via a software update in the United States and select approved markets starting in the fourth quarter of 2026. Exact regional rollout dates and a complete list of international markets beyond the US remain unannounced.
