February 6, 2006

A new study has found that children with cochlear implants are at increased risk for bacterial meningitis that persists beyond two years after implantation. The study, published in the February issue of the journal Pediatrics, followed children beyond two years of implantation and highlights the importance of continuing to monitor children with cochlear implants for signs of middle ear infection and meningitis. The study authors said children should be monitored for as long as the implants are in place.

An earlier study conducted by the FDA and the Centers for Disease Control and Prevention, which appeared in the July 31, 2003 New England Journal of Medicine, showed that children whose implants have a positioner get bacterial meningitis more often than children with implants that don't have positioners or children without implants. A positioner is a small rubber wedge that helps the physician position the implant during surgery. That study followed children with cochlear implants for two years after the devices were implanted.

The new study followed children from the original study for an additional two years. Six children with positioners developed meningitis after two years. Of these six, three developed meningitis between three and four years after implantation. The study also concluded there is not enough information now to recommend surgical removal of devices with a positioner.

The original CDC/FDA study reviewed the medical records of 4,264 children under the age of six at the time of implantation. The study was undertaken because of increased concern about the risk of meningitis associated with cochlear implants. The study focused on young children because they account for most known meningitis cases, and they represent the population that now receives a large proportion of cochlear implants

For more information, visit http://www.fda.gov/cdrh/safety/020606-cochlear.html (http://www.fda.gov/cdrh/safety/020606-cochlear.html). For general information on cochlear implants visit http://www.fda.gov/cdrh/cochlear/ (http://www.fda.gov/cdrh/cochlear/)