Auditory Brainstem Implant Cleared by FDA

A brainstem implant for use in patients suffering from deafness caused by neurofibromatosis Type II (NF2) has been cleared by the U.S. Food and Drug Administration (FDA). Called the Nucleus 24 Multichannel Auditory Brainstem Implant, the implant is the first multichannel device designed to bypass the auditory nerve and cochlea to transmit sound signals directly to the brain.

NF2 is characterized by the development of tumors on the cranial and spinal nerves. Many people suffering from NF2 develop tumors on both auditory nerves. When the tumors are removed, surgeons often find it necessary to also remove parts of the auditory nerve, resulting in total deafness. The new implant allows the recipient to hear environmental sounds and speech.

The technologically advanced implant comprises a 21-electrode array that provides sound information. The technology was developed after more than 20 years of research and involved the collaborative efforts of the Huntington Medical Research Institute, the House Ear Institute, and the Cochlear Corp. (Denver, CO, USA), which is manufacturing the device.