Tony Lambert delphine@videotron.ca

14/102007

October 11, 2007 — Cochlear implant recipients must be fully immunized according to the Centers for Disease Control and Prevention (CDC) pneumococcal vaccination recommendations, the US Food and Drug Administration warned healthcare professionals on yesterday. Pediatric patients should be vaccinated under the same schedules that apply to other persons at high risk for invasive disease.

Although all patients with a cochlear implant are at increased risk for pneumococcal meningitis, children who have a device with a positioner component are at greatest risk.

During the past year, meningitis-related deaths were reported in 2 inadequately vaccinated children aged 9 and 11 years — both of whom had received a cochlear implant with positioner.

At least 1 child was infected with the vaccination-preventable serotype Streptococcus pneumoniae, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

Lack of proper vaccination is not uncommon in this high-risk population. According to an FDA public health notification, a recent survey of the Johns Hopkins University cochlear implant patient population revealed that 29% of parents/legal guardians of children younger than 2 years did not know if their child had been fully vaccinated.

Moreover, vaccination status was unknown for 43% of children older than 2 years, and a further 12% were known to be inadequately vaccinated.

Healthcare professionals are advised to review the vaccination status of all current and potential pediatric implant recipients. Relevant CDC guidelines are available at http://www.cdc.gov/vaccines/vpd-vac/mening/cochlear/dis-cochlear-hcp.htm.

The FDA notes that implant recipients and their caregivers should be able to discern early signs of meningitis, thereby ensuring early intervention and minimization of neurologic and other sequelae.

Because signs of otitis media were observed in some meningitis cases, prompt diagnosis and treatment of pediatric ear infections is advised. Use of antibiotics should be considered in this setting, as well as perioperatively for children undergoing implantation.

Cochlear implants (also known as bionic ears) are used to provide a sense of sound in persons who are profoundly deaf or severely hard of hearing. Devices with positioners were manufactured by Advanced Bionics Corporation and were withdrawn from the market in July 2002.

Additional information regarding the risk for meningitis in children with cochlear implants may be obtained by contacting Nancy Pressly at the Office of Surveillance and Biometrics (HFZ-510) by mail at 1350 Piccard Drive, Rockville, MD, 20850, by fax at 240-276-3356, or by email at phann@cdrh.fda.gov. Voicemail messages left at 240-276-3357 will be answered as soon as possible. Healthcare professionals are encouraged to report cases of meningitis in cochlear implant recipients to the device manufacturer. Alternatively, this information may be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.