FDA Issues New Classification for Implantable Bone Conduction Hearing System

The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls.

Clinical performance testing for the device must characterize any adverse events that occur during clinical use and implantation, and the testing must also demonstrate that the device serves its intended purpose under the anticipated conditions of use, the agency said.

Non-clinical testing, meanwhile, must demonstrate that the device performs as intended, including performance data that validates force output, mechanical integrity testing, and reliability testing that aligns with expected device life.