Samsung Electronics’ Galaxy Earbuds have secured US Food and Drug Administration (FDA) clearance for a new hearing aid feature, adding to the over-the-counter (OTC) hearing aid space opened by Apple two years ago.
The agency’s clearance for the feature means that individuals 18 years or older with mild to moderate hearing impairment will be able to use the earphones as hearing aids without a prescription. Users will also be able to diagnose their hearing with the Galaxy Buds Hearing Test feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results, Samsung stated.
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Clearance for Samsung’s hearing aid feature is the culmination of hearing-related features the South Korean electronics company has been adding to it earbuds, which include its personal sound amplification product (PSAP) feature, added to the Galaxy Buds+ in 2020.
Hearing loss is a common issue yet remains one of the most overlooked health conditions worldwide. The World Health Organization (WHO) estimates more than 1.5 billion people experience some degree of hearing loss, with this figure projected to reach 2.5 billion by 2050.
Following FDA clearance, Samsung intends to roll out its Hearing Aid and Hearing Test features on Galaxy Buds3 Pro and Galaxy Buds4 Pro 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, commented: “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’s FDA clearance follows the agency’s clearance of Apple’s AirPod Pro headphones in September 2024, which are also indicated for use in patients aged 18 and above with mild to moderate hearing impairment. Clearances in this indication for widespread consumer devices are improving hearing aid accessibility. For example, including hearing aid software in everyday devices reduces stigma, especially in young people with hearing issues.
Previously in conversation with Medical Device Network shortly after Apple’s clearance, Royal National Institute for Deaf People’s audiology manager Franki Oliver said the institute was excited about the technology’s potential but stressed that audiologists still have a key role to play in evaluating individuals’ hearing.
