Background information
Background: In 2002, the U.S. Food and Drug Administration (FDA) received a series of reports concerning bacterial meningitis in pediatric cochlear implant recipients. These reports triggered a formal investigation, which was conducted by the Centers for Disease Control and Prevention (CDC), FDA, and health departments from 36 states and three cities. Results of the investigation were published in the New England Journal of Medicine1 and indicated that the incidence (rate) of bacterial meningitis in children with cochlear implants was 30 times higher than that for children in the general U.S. population. The study also found that this increased risk continued for up to 24 months post-implant, and that the risk of meningitis was significantly higher for children who received cochlear implants with electrode positioners.
Important outcomes from this landmark study included (1) a voluntary decision by Advanced Bionics (a cochlear implant manufacturer) to withdraw all devices with electrode positioners from the market, (2) the CDC’s recommendation that both cochlear implant recipients and potential recipients be immunized against meningitis and, (3) an increased awareness of meningitis and its symptoms by parents of implanted children and health care professionals.
1Reefhuis J, Honein MA, Whitney CG et al. Risk of bacterial meningitis in children with cochlear implants. N Engl J Med. 2003;349:435-445
New Information: The CDC has continued to study the relationship between meningitis and cochlear implants and, on February 6, 2006, published results of an important follow-up investigation2 . The study included over 4000 implanted children (the same group of children who were studied in 2002) and evaluated all new reports of bacterial meningitis. After following these children for two more years, the authors concluded that the children who received cochlear implants with electrode positioners remained at a higher risk for meningitis and, importantly, that this elevated risk continued for as long as 48 months, post-implant. Specifically, the study found that the incidence of meningitis (occurring 24 months or longer, post-implant) was 450 cases per 100,000 persons years in children implanted with devices with positioners, compared to no cases in children implanted with devices without positioners.
Based on this finding, the CDC recommended that parents and health care providers continue to monitor implanted children for symptoms of meningitis for up to 48 months post-implant, particularly children with electrode positioners, and that health care professionals continue to immunize both current and potential cochlear implant recipients.
2 Biernath KR, Reefhuis J, Whitney CG et al. Bacterial meningitis among children with cochlear implants beyond 24 months after implantation. Pediatrics. 2006;117:284-289
