July 24, 2002
The FDA has become aware of a possible association between cochlear implants 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 9 known deaths resulted from these cases. At this time, 2 out of 3 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 5 cases and none had been vaccinated. The onset of meningitis symptoms ranged from less than 24 hours to greater than 5 years from time of implant.
What are Cochlear Implants?
Cochlear implants are 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. Approximately 60,000 implantations have been performed worldwide to date.
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 and vomiting, and confusion or alteration in consciousness. Physicians are encouraged to consider a diagnosis of meningitis in cochlear implant patients when such symptoms exist and to begin appropriate diagnosis and treatment as soon as possible.
The younger patient population (< 2 yr) and the elderly are most vulnerable to meningitis.
Predisposition to Meningitis
A small percentage of deaf patients may have congenital abnormalities of the inner ear which predispose them to meningitis even prior to implantation. Other predisposing factors may include otitis media, immunodeficiency status, prior history of meningitis, or surgical technique. The cochlear implant, because it is a foreign body, may act as a nidus for infection when patients have bacterial illnesses.
Cochlear Implants and Otitis Media
In some of the reported cases of meningitis in cochlear implant recipients, patients may have had overt or sub-clinical otitis media prior to surgery or before the meningitis developed. Physicians are encouraged to consider prophylactic antibiotic treatment prior to implantation, as appropriate, and to diagnose and treat otitis media promptly in patients with cochlear implants.
Cochlear Implants and Vaccination
Cochlear implant candidates, as well as those already implanted, may benefit from vaccinations against organisms that commonly cause bacterial meningitis, particularly Streptococcus pneumoniae and Haemophilus influenzae.Â Â The immunization status should be ascertained for all candidates for cochlear implants prior to surgery as well as for those with an existing implant. Haemophilus influenzae conjugate vaccines are recommended by the Advisory Committee on Immunization Practices (ACIP) for all children up to age 5 years.Â
Heptavalent pneumococcal conjugate vaccine (PrevnarÂ®) is indicated for use in infants and toddlers, and is recommended by the ACIP for all children less than age 2 years, and for children up to age 5 years who are at high risk of invasive pneumococcal infections.Â
The 23-valent pneumococcal polysaccharide vaccines (Pnu-ImuneÂ®23 and PneumovaxÂ®23) are recommended for children over age 2 years, adolescents, and adults who are at high risk of invasive pneumococcal disease.Â Â
For children age 2 years to 5 years of age who are at high risk of invasive pneumococcal infections, ACIP recommends use of pneumococcal conjugate vaccine followed at least 2 months later by 23-valent pneumococcal polysaccharide vaccine, in order to provide protection against a broader range of serotypes, although supporting data are limited1.Â See individual product labeling for information on dosing and scheduling of the vaccines.Â For additional information regarding immunizations refer to the National Vaccine Program Office of the Centers for Disease Control and Prevention (http://www.cdc.gov/od/nvpo/).
Reporting Cases of Meningitis in Cochlear Implant Recipients
We encourage you to report cases of meningitis in cochlear implant recipients. You can report these directly to the device manufacturer or you can report them to MedWatch, the FDAs voluntary reporting program. You may submit reports to MedWatch one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/ by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
Office of Surveillance and Biometrics (HFZ-510)
1350 Piccard Drive, Rockville, Maryland, 20850
Fax at 301-594-2968, or by e-mail at email@example.com
Additionally, a voice mail message may be left at 301-594-0650 and your call will be returned as soon as possible.
1Preventing Pneumococcal Disease Among Infants and Young Children Recommendations of the Advisory Committee on Immunization Practices (ACIP) October 06, 2000 / 49(RR09);1-38.
July 24, 2002