Samsung’s Galaxy Buds cleared by FDA to function as OTC hearing aids
A new hearing test and amplification tool will roll out to the Galaxy Buds 3 Pro and Buds 4 Pro in Q4 2026
Samsung has received clearance from the US Food and Drug Administration (FDA) for a new Galaxy Buds Hearing Aid feature, turning compatible wireless earbuds into over-the-counter (OTC) hearing aids for adults aged 18 and older with perceived mild-to-moderate hearing loss.
Scheduled to roll out in Q4 2026 via a software update for the Galaxy Buds 3 Pro and the Galaxy Buds 4 Pro, the feature directly mirrors Apple’s hearing health tools on the AirPods Pro 2 and Pro 3.
The functionality is anchored by two tools built directly into the Galaxy Buds settings menu on compatible Galaxy smartphones running One UI 8 (or later): a self-administered Hearing Test, and the Hearing Aid amplification tool.
Registered as Software as a Medical Device (SaMD), the five-minute Hearing Test uses pure-tone audiometry to evaluate each ear individually.
It generates a clinical-grade audiogram—stored and accessible in the Samsung Health app—that classifies hearing levels into normal, mild, moderate, severe, or profound categories.
If mild or moderate hearing loss is identified, the Hearing Aid feature uses the clinical standard NAL-NL2 prescription formula to automatically calibrate audio.
The earbuds amplify target frequencies that users struggle with—such as high-pitched sounds, distant voices, or soft whispers—while leveraging built-in beamforming microphones and noise elimination to clarify speech in noisy settings.
Commenting on the FDA clearance in Samsung's announcement post, Hon Pak, Senior Vice President and Head of the Digital Health Team at Samsung Electronics, said:
“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. With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.”
Samsung collaborated with the National Acoustic Laboratories (NAL) and Samsung Medical Center to develop the software, backed by clinical validation studies conducted across several US universities.
The move expands on Samsung’s earlier hearing experiments—which began with a Personal Sound Amplification Product (PSAP) feature on the Galaxy Buds+ in 2020—as mainstream earbud makers increasingly position true wireless audio as accessible medical hardware.
