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U.S. Department of Health and Human Services

Safety

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Cochlear Implants July 2002

Audience: ENT Healthcare professionals

[UPDATE posted 7/31/2003] FDA notified healthcare providers about a recent study showing that children with cochlear implants are at greater risk of developing bacterial meningitis caused by Streptococcus pneumoniae than children in the general population. The study, conducted by FDA, the Centers for Disease Control (CDC) and others, was published in the July 31, 2003 issue of The New England Journal of Medicine.

[Posted July 24, 2002] FDA/CDRH notified healthcare professionals 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. Surveys of cochlear implant centers currently underway suggest there are additional, unreported, cases of meningitis in the cochlear implant population.

[July 24, 2002 - Public Health Notification - FDA] PAGE UPDATED 7/31/2003