Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA

Samsung Electronics Co., Ltd. today announced that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy Buds¹ to serve as an over-the-counter (OTC) hearing aid,² offering users over the age of 18 a convenient solution for addressing perceived mild to moderate hearing loss - which may be indicated by difficulty following conversations in noisy environments - without a prescription or clinic visit. Users can also diagnose their hearing with the Galaxy Buds Hearing Test feature (available on Galaxy Buds3 Pro and Galaxy Buds4 Pro), which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.

"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," said Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics. "With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating Hearing Test and Hearing Aid functionality directly into the Galaxy Buds."