Bacterial Meningitis Kills Two Children with Cochlear Implants, Prompting FDA WarningOct 11, 2007 | Parker Waichman LLP
Children with Cochlear implants are at a higher risk for developing bacterial meningitis, a potentially deadly infection, and must be fully immunized against the disease. That warning came from the Food & Drug Administration (FDA) after it learned that two children with Cochlear implants had recently died from bacterial meningitis.
A Cochlear implant is an electronic hearing device that works by stimulating nerves inside the inner ear. It is designed to produce useful hearing sensations to children and adults with severe to profound nerve deafness. The FDA approved the first commercial Cochlear devices during the mid-1980s.
In 2006, the FDA issued letters to patients and doctors that deaf children who have a Cochlear implant with a positioner are likely get bacterial meningitis more frequently than either children with the implants that don't have the small rubber wedge or those without implants at all. Only one Cochlear implant has a positioner and that device was withdrawn from the market in July 2002.
In its latest health alert, the FDA said that two children – ages 9 and 11 – with Cochlear implants had died from bacterial meningitis in the past year. Neither had been fully immunized against the disease, and both had Cochlear implants with positioners.
Meningitis is an inflammation of the protective covering of the central nervous system. Symptoms include high fever, headache, stiff neck, nausea, or vomiting, discomfort looking into bright lights, sleepiness, or confusion. Some patients have ear pain or ear infection. Very young children may be sleepy, cranky, or eat less. Bacterial meningitis is always a medical emergency and can be fatal. But the disease can be prevented through appropriate vaccination.
Unfortunately a recent study conducted by Johns Hopkins University found that only 29% of parents or guardians of children younger than two with cochlear implant knew whether their children were properly vaccinated. The same survey also found that vaccination status was also unknown for 43% of implant patients older than two.
In addition to recommending vaccinating children with Cochlear implants against bacterial meningitis, the FDA also is advising parents, teachers and caregivers of children with Cochlear implants to become familiar with the signs and symptoms of the disease. The FDA is also cautioning physicians to treat ear infections in Cochlear implant recipients aggressively, as many children had presented with middle ear infections immediately prior to the development of bacterial meningitis. And finally, the FDA advised doctors to consider prescribing preventative antibiotics to children who are about to receive a Cochlear implant.