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U.S. Department of Health and Human Services


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Cochlear Implants

Audience: ENT specialists, pediatricians, infectious disease specialists, other healthcare professionals, consumers

[Posted 10/10/2007] FDA informed healthcare professionals and consumers that the Cochlear Implant device used in profoundly deaf or severely hard-of hearing patients has been associated with some increased risk of bacterial meningitis caused by Streptococcus pneumoniae. Children implanted with Cochlear Implants with a positioner component are at a greater risk. There were two cases of deaths from meningitis within the past year in children, ages 9 and 11, implanted with cochlear implants with positioners. Neither child was fully vaccinated, and one died because of the lack of vaccination.

FDA reminds healthcare professionals and consumers that recipients of this device must be fully immunized according to the Center for Disease (CDC) vaccination recommendations. Because children with Cochlear Implants are at increased risk for pneumococcal meningitis, CDC recommends that they receive pneumococcal vaccination under the same schedules that apply to other individuals at high risk for invasive pneumococcal disease.

[October 10, 2007 - Public Health Notification - FDA]
[October 10, 2007 - Advice for Patients - FDA]