October 24, 2007

The Food and Drug Administration (FDA) has informed health care 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, according to the FDA.

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

For more information, visit http://www.fda.gov/cdrh/safety/101007-cochlear.html.