Samsung Galaxy Buds Gain FDA Clearance for Over-the-Counter Hearing Aid Feature
Key Insights
Samsung (search) received FDA clearance for a Hearing Aid feature in the Galaxy Buds 3 Pro and Buds 4 Pro, transforming consumer earbuds into over-the-counter hearing aids.
The software-based feature uses a self-administered hearing test and NAL-NL2 fitting formula to amplify sounds for adults 18 and older with perceived mild-to-moderate hearing loss (search).
The feature will roll out to eligible users in the US and select markets in Q4, positioning Samsung (search) in direct competition with Apple (search)'s AirPods Pro hearing health suite.
Samsung (search) has secured U.S. Food and Drug Administration (FDA) clearance for an over-the-counter hearing aid feature in its Galaxy Buds 3 Pro and Buds 4 Pro, bringing clinical-grade hearing assistance directly to consumer wireless earbuds. The feature, which amplifies ambient sound to turn the Galaxy Buds into an over-the-counter hearing aid, will begin rolling out to eligible users in the fourth quarter.
The regulatory green light positions the South Korean tech giant in direct competition with Apple (search)'s AirPods Pro hearing health suite, which pioneered a similar approach. The functionality transforms standard consumer earbuds into over-the-counter (OTC) medical devices tailored for adults aged 18 and older who experience perceived mild to moderate hearing loss (search).
How the Hearing Aid Feature Works
The system centers on a five-minute self-administered test accessed through the Galaxy Buds app. Utilizing pure-tone audiometry, the software evaluates each ear independently across varying frequencies to construct a personalized audiogram. Samsung (search) says the test will analyze each ear individually, generate an audiogram comparable to a professional audiologist's evaluation, and categorize a user's hearing as normal or one of four stages of hearing loss (search): mild, moderate, severe, or profound.
Once a tone map is created, the software selectively enhances targeted audio ranges that individuals struggle to perceive, such as high-pitched tones, distant voices, or soft whispers in crowded settings. This profile automatically calibrates audio output using NAL-NL2, a globally recognized standard fitting formula used in professional prescription hearing aids.
For users with perceived mild-to-moderate hearing loss (search), the Hearing Aid feature will amplify hard-to-hear sounds such as high frequencies, whispers, and distant voices. To maintain speech clarity in chaotic environments, the system leverages multi-mic beamforming to isolate the voice of a speaker directly in front of the user while active noise cancellation algorithms suppress ambient background clutter. Samsung (search)'s Hearing Aid feature will also have controls for noise elimination and beamforming, which helps "focus sounds in front of the user and suppress background noise," according to the company.
All hearing insights, hearing test results, and noise exposure metrics sync to the Samsung (search) Health app, giving users a continuous snapshot of their auditory wellness alongside traditional fitness metrics.
Clinical Development and Validation
Samsung (search)'s entry into auditory health builds on years of clinical groundwork. The company first introduced sound amplification tools on the Galaxy Buds+ in 2020. Samsung developed the Hearing Aid feature in collaboration with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC), and conducted validation studies at Vanderbilt University Medical Center, San Jose State University, and the University of Memphis to validate its algorithms against traditional medical standards.
Regulatory Context and Market Positioning
The regulatory approval arrives amid a broader transformation in the hearables market, driven by the FDA's 2022 creation of the OTC hearing aid category aimed at lowering cost barriers and reducing the social stigma surrounding traditional hearing aids. The approach saves users a visit to the audiologist or the need for separate prescription hardware.
As of this writing, Samsung (search)'s hearing aid feature is limited to the Galaxy Buds3 Pro ($218.35) and Galaxy Buds4 Pro ($249.99), requiring a connected Samsung smartphone running One UI 8 or later to execute the clinical processing. Both the Hearing Aid feature and hearing tests will begin rolling out to eligible adult users in the US and select other approved markets next quarter.
Despite the FDA's approval, Samsung (search) reminds that its Hearing Aid feature "is not a substitute for professional diagnosis or treatment by a qualified clinician."