The U.S. Food and Drug Administration (FDA) has become aware of a possible association between cochlear implants, devices containing electrodes which are positioned in the cochlea (inner ear) to activate auditory nerve fibers allowing for transmission of sound signals to the brain, and the occurrence of bacterial meningitis. At least 25 cases of meningitis have been diagnosed worldwide in children and adults ranging in age from 21 months to 63 years who have undergone cochlear implantation for severe to profound deafness. A total of nine known deaths resulted from these cases. At this time, two out of three companies have reported cases of bacterial meningitis in patients who have been implanted. FDA is following up with all the manufacturers of cochlear implants. Surveys of cochlear implant centers currently underway suggest there are additional, unreported, cases of meningitis in the cochlear implant population.

Cerebrospinal fluid culture results are available in 11 cases. Seven have grown Pneumococcus and four have grown Diplococci (most likely Pneumococcus). The vaccination history against Pneumococcus was available in five cases and none had been vaccinated. The onset of meningitis symptoms ranged from less than 24 hours to greater than five years from time of implant.