At least 13 people with cochlear implants to restore their hearing have come down with meningitis, including two preschoolers who died, the government said Thursday — warning that the implants might allow an infection to fester deep in the ear.
In addition to the U.S. illnesses, health authorities are investigating at least another dozen meningitis cases and seven deaths among cochlear implant recipients in other countries.
The Food and Drug Administration so far has found no evidence that the implants are contaminated, stressed medical device chief Dr. David Feigal.
Any material implanted in the body, from heart valves to artificial joints, can allow infections to fester that the body otherwise could clear, he explained.
Some deaf patients have inner-ear abnormalities that predispose them to meningitis by letting bacteria build up near the brain even without a cochlear implant.
But the implants may prove an additional risk factor, Feigal said.
So the FDA on Thursday issued an alert to doctors urging them to report any additional suspicious meningitis cases — and urging that they aggressively treat ear infections in patients who have cochlear implants and make sure that child patients are properly vaccinated against meningitis.
The meningitis cases appear to be caused by a bacterial infection that can be prevented with a vaccine called Prevnar, which the government now recommends that all children get by age 2.
The 13 U.S. patients ranged in age from 21 months to 63 years old. The two children who died were between ages 2 and 3. Meningitis is most dangerous to the very young and the elderly.
About 22,000 Americans have cochlear implants, which send auditory signals to the brain to restore hearing in people with certain types of hearing loss. They are supposed to get preventive antibiotics during the implantation, the FDA said.