Over the past few months the 3 major cochlear implant manufacturers have been surveying the implant centers to determine the frequency of meningitis in patients with cochlear implants. This was prompted by a relatively small number of cases of meningitis (25) in the 60,000 cochlear implant recipients worldwide. Since meningitis is a serious, life-threatening infection, the FDA produced a public advisory concerning this issue despite the fact that no clear association between cochlear implants and an increased risk of meningitis has been demonstrated. This advisory makes recommendations concerning vaccination against meningitis causing bacteria that should be followed until more definitive data can be obtained.

Meningitis is an infection of the lining of the surface of the brain. Early symptoms of meningitis include fever, irritability, lethargy and loss of appetite in infants and young children. Older children and adults may also manifest headache, stiff neck, nausea, vomiting, confusion or alteration in consciousness. The younger patient population (< 2 yr) and the elderly are most vulnerable to meningitis. Middle ear infections (otitis media) have always been a major cause of meningitis in the general population. Every year thousands of otherwise healthy individuals who do not have a cochlear implant die of meningitis, both children and adults. Meningitis caused by otitis media is also a common cause of deafness in those who survive the initial infection.

Hearing impaired individuals, especially those born with cochlear malformations, are considered to have an increased risk of meningitis even without a cochlear implant. Therefore, you can see the challenge of determining whether or not a cochlear implant was actually to blame for a case of meningitis in such patients. It is theoretically possible for the cochlear implant electrode to provide a pathway for an ear infection to spread into the inner ear and cause meningitis. As of the date of this letter, the Dallas Otolaryngology Cochlear Implant Program has performed 131 cochlear implant procedures. We have had no cases of post implant meningitis in 12 years. It has not been shown that any preventative or remedial action is needed in patients who have or will receive cochlear implants. However, for the safety of our patients, we support the following recommendations:

All existing and prospective cochlear implant patients should be immunized against the bacteria that are the most common causes of meningitis for their age group. Prospective patients should be immunized before surgery.

It is possible that the recommendations may eventually prove to be unnecessary.

My office will report all cases of meningitis to the FDA and implant manufacturers. Please print this document and take it to your pediatrician or primary care physician to receive the appropriate immunizations.

For more information, visit the following sites:

• The U.S. Food and Drug Administration web notification regarding cochlear implants and meningitis.
• The Center for Disease Control's National Vaccine Program Office web site.