
The FDA reminded physicians on Wednesday that patients with cochlear implants, especially implants with a positioner, are at risk for bacterial meningitis from Streptococcus pneumoniae. This warning follows the deaths of two children within the past year, ages 9 and 11 years, who had implants with a positioner and were not fully vaccinated. (Only one implant model has a positioner, and it was withdrawn from the market 5 years ago.)
A recent survey of the Johns Hopkins University cochlear implant patient population, conducted by Dr. John Niparko, revealed that despite repeated information bulletins from the University regarding the importance of vaccination, 29% of the parents/guardians of patients under 2 years of age were uncertain of the child’s vaccination status. Vaccination status was unknown in 43% of children older than two years, and 12% were known to be not properly vaccinated. These findings strongly suggest that patients are not receiving vital preventive care that can reduce their risk of this life-threatening illness. FDA is working with the CDC, cochlear implant manufacturers, and professional societies to heighten awareness of the importance of vaccinations in the cochlear implant population.
To decrease the risk for meningitis in this population, the FDA recommends:
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following the CDC's vaccination guidelines;
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educating implant recipients and their caregivers about the early signs of meningitis;
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treating middle ear infections early;
- considering prophylactic antibiotics perioperatively.
http://www.fda.gov/cdrh/safety/101007-cochlear.html
http://www.cdc.gov/vaccines/vpd-vac/mening/cochlear/dis-cochlear-hcp.htm