Samsung Galaxy Buds Hearing Aid Cleared by FDA for OTC Use

The Samsung Galaxy Buds hearing aid feature has landed US Food and Drug Administration (FDA) clearance. The clearance puts Samsung Electronics in the over-the-counter (OTC) hearing aid space. That is the space Apple opened two years ago.

Under the clearance, adults 18 or older with mild to moderate hearing impairment can use the earphones as hearing aids. No prescription needed. Users can also self-check with the Galaxy Buds Hearing Test feature. Samsung stated that feature is registered as a Software as a Medical Device (SaMD). It gives medical-grade results.

What the Samsung Galaxy Buds hearing aid feature covers

The Samsung Galaxy Buds hearing aid clearance covers two functions. The first is the hearing aid mode itself. The second is the on-device hearing test.

Samsung will roll out both Samsung Galaxy Buds hearing aid capabilities on Galaxy Buds3 Pro and Galaxy Buds4 Pro. The rollout starts in the US and select approved markets in Q4 2026.

Hon Pak, senior vice president and head of the digital health team for the mobile eXperience (MX) business at Samsung Electronics, framed the launch as an accessibility play.

Pak 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."

Pak added: "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's hearing feature timeline

The Samsung Galaxy Buds hearing aid clearance caps a multi-year push. The South Korean electronics company has been adding hearing-related features to its earbuds for years.

Samsung added a personal sound amplification product (PSAP) feature to the Galaxy Buds+ in 2020. That laid the groundwork for its current hearing aid classification.

Global hearing loss scale

Hearing loss is a common condition. But it remains one of the most overlooked health conditions worldwide.

The World Health Organisation (WHO) estimates more than 1.5 billion people live with some degree of hearing loss. That figure is projected to reach 2.5 billion by 2050.

Apple AirPods precedent and consumer device impact

Samsung's FDA clearance follows the agency's clearance of Apple's AirPods Pro headphones in September 2024. Those are also indicated for adults aged 18 and above with mild to moderate hearing impairment.

Two consumer-device clearances in two years mark a shift. OTC hearing aid access is expanding beyond speciality channels. The move can reduce stigma too. That matters especially for young adults with hearing issues.

Audiologist role remains key

Consumer devices do not replace clinical assessment. Franki Oliver is the audiology manager at the Royal National Institute for Deaf People. Speaking with Medical Device Network shortly after Apple's clearance, Oliver said the institute was excited about the technology's potential. But she stressed that audiologists still play a key role in evaluating individual hearing.

For clinics, primary care, and audiology teams, the Samsung Galaxy Buds hearing aid launch expands the tools patients bring in. It also raises the bar for triage and pairing. Coverage on Medigear.uk tracks how consumer hearing devices reshape the OTC market.

Source: Originating coverage based on Medical Device Network reporting on Samsung Electronics' US Food and Drug Administration (FDA) clearance for a hearing aid feature on Galaxy Buds, by Ross Law, August 14, 2026.