Cochlear - FDA 510(k) Cleared Devices

Cochlear, is a global leader in implantable hearing solutions. The company develops and manufactures cochlear implant systems, bone conduction devices, and complementary accessories. Cochlear operates with a manufacturing facility in Centennial, US, and has helped over 700,000 people restore hearing worldwide.

Cochlear has received 3 FDA 510(k) clearances from 3 total submissions since 2023. The company specializes in Ear, Nose, Throat devices, including implantable sound processors and surgical instruments. The latest clearance was in 2025, confirming active regulatory engagement and ongoing product innovation.

Recent cleared devices include bone conduction sound processors, cochlear implant systems, and associated surgical instrumentation. The company's product portfolio spans multiple hearing restoration technologies designed for both adult and pediatric patients. Cochlear remains committed to advancing implantable auditory solutions and expanding access to hearing restoration therapies.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.