Brief Update

Meningitis and Cochlear Implants

Source: FDA Public Health Notification, July 24, 2002. (www.accessdata.fda.gov/scripts/medwatch)

The FDA issued a public health advisory in late July regarding a possible association between cochlear implants and bacterial meningitis. Cochlear implants are a novel new technology that allows activation of auditory nerve fibers via electrodes implanted in the inner ear. An estimated 60,000 individuals worldwide have been implanted with the devices. Unfortunately, at least 25 adults and children with the implants, varying in age from 21 months to 63 years, have developed meningitis. Nine persons have died. Infections in several patients were due to pneumococcus (none of these persons were vaccinated to this organism). The basis for the increased risk of infection is not clear, but probably is not a result of contamination of the device. Rather, it is believed that many people who are candidates for the device have sub-chronic or chronic otitis, or congenital abnormalities that predispose them to middle ear infections—and subsequent meningitis. The device may additionally serve as a nidus of infection in the inner ear.

The FDA is seeking information regarding possible additional cases (Office of Surveillance and Biometrics, e-mail: phann@cdrh.fda.gov). In the meantime, it has been suggested that patients receiving cochlear implants receive prophylactic antibiotics or treatment for middle ear infection prior to surgery. The immunization status of candidates should be evaluated and consideration should be given to vaccination against S pneumoniae and Haemophilus influenzae.

This Brief Update was written by Carol Kemper, MD. Dr. Kemper is Clinical Associate Professor of Medicine, Stanford University, Division of Infectious Diseases, Santa Clara Valley Medical Center, Palo Alto, Calif.