Samsung Galaxy Buds receive FDA clearance for over-the-counter hearing aid feature
The company has registered the software as a Software as a Medical Device (SaMD) and says it provides clinical-grade hearing assessment results.
SOUTH KOREA—Samsung Electronics’ Galaxy Buds have received US Food and Drug Administration (FDA) clearance for a new hearing aid feature, allowing the earbuds to function as over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss.
The clearance applies to users aged 18 and older, who can use the feature without a prescription or medical examination, in line with the FDA’s requirements for OTC hearing aids.
Samsung will also offer a hearing test feature that allows users to assess their hearing through the Galaxy Buds.
The company has registered the software as a Software as a Medical Device (SaMD) and says it provides clinical-grade hearing assessment results.
The hearing test measures hearing levels and uses the results to personalize sound amplification.
The hearing aid feature can then enhance sounds according to the user’s hearing profile while using technologies such as active noise cancellation to help reduce unwanted background noise.
Galaxy Buds expand hearing health features
The FDA clearance builds on Samsung’s efforts to introduce hearing-related capabilities into its earbuds.
The company previously added personal sound amplification product (PSAP) functionality to the Galaxy Buds+ in 2020.
Samsung’s latest development comes as hearing loss remains a widespread health concern.
The World Health Organization estimates that more than 1.5 billion people worldwide experience some degree of hearing loss, with the number expected to rise to 2.5 billion by 2050.
OTC hearing aids became available in the US in October 2022 for adults with perceived mild to moderate hearing loss.
The category allows eligible consumers to purchase hearing aids without a prescription or involvement from a healthcare professional.
Rollout planned for late 2026
Following the FDA clearance, Samsung plans to introduce the Hearing Aid and Hearing Test features on the Galaxy Buds3 Pro and Galaxy Buds4 Pro in the US and selected approved markets during the fourth quarter of 2026.
Hon Pak, senior vice president and head of the Digital Health Team for Samsung Electronics’ Mobile eXperience (MX) business, said hearing health plays an important role in communication, relationships and engagement 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,” he said.
Samsung follows Apple into OTC hearing care
Samsung’s FDA clearance follows Apple’s regulatory milestone for its AirPods Pro hearing aid feature in September 2024.
The FDA cleared Apple’s Hearing Aid Feature through its De Novo pathway for adults aged 18 and older with perceived mild to moderate hearing impairment.
The growing use of hearing technologies in everyday consumer devices could make hearing support more accessible while reducing some of the stigma associated with traditional hearing aids.
However, audiologists continue to have an important role in assessing hearing health and identifying conditions that may require professional care.
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