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Winter 2003 Table of Contents
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FDA Public Health Web Notification: Cochlear Implant Recipients May Be at Greater Risk for Meningitis

Reprinted with permission from the U. S. Food and Drug Administration
Center for Devices and Radiological Health
Originally issued July 24, 2002 - Updated: October 17, 2002

The Food and Drug Administration (FDA) has become aware of a possible association between cochlear implants and the occurrence of bacterial meningitis. Worldwide, we know of 91 reports of meningitis in patients implanted with the three FDA-approved cochlear implant devices: Advanced Bionics Corporation devices (56 cases), Cochlear Limited devices (33 cases) and MED-EL Corporation devices (1 case). A total of 17 deaths have resulted from these meningitis cases.

Within the U.S., the FDA is aware of 52 cases of post-implant meningitis: Advanced Bionics Corporation devices (29 cases), Cochlear Limited devices (22 cases), and MED-EL Corporation device (1). Five cases resulted in death. Cochlear Limited, Advanced Bionics, and MED-EL devices were approved in 1985, 1996, and 2001, respectively. All cases are currently being investigated. According to information supplied by the manufacturers, the one MED-EL Corporation case and the majority of the Cochlear Limited cases had predisposing factors for meningitis unrelated to the implant (e.g., Mondini inner ear deformity, pre-implantation history of meningitis—see Predisposing Factors section below).

Case Information

The ages of the U.S. meningitis patients ranged from 18 months to 84 years but most (33) of the patients were under 7 years of age at the time they developed meningitis.

Patients in the U.S. had onset of meningitis symptoms from less than 24 hours to greater than 6 years after implant. Thirty-two U.S. patients developed meningitis within one year post implantation, many within the first few weeks of surgery.

We have received cerebrospinal fluid (CSF) culture results in 23 cases in the United States. The organisms identified are: Streptococcus pneumoniae (pneumococcus) (16), Haemophilus influenzae (4), Streptococcus viridans (2), and Escherichia coli (1). Although vaccination is usually protective against both pneumococcus and H. influenzae, 2 cases of pneumococcal meningitis and 2 cases of H. influenza meningitis developed after the patient had received the appropriate vaccine.

Predisposing Factors

The cause of meningitis in the cochlear implant recipients has not been established. Some deaf people may have congenital abnormalities of the cochlea which predispose them to meningitis even prior to implantation. People who become deaf as a result of meningitis are also at increased risk of subsequent episodes of meningitis compared to the general population. Other predisposing factors may include young age (< 5 years), otitis media, immunodeficiency, and surgical technique. The cochlear implant, because it is a foreign body, may act as a nidus for infection when patients have bacterial illnesses.

Design of the electrode is also being considered as a possible predisposing factor. Advanced Bionics electrodes with positioners (HiFocus I and HiFocus II) have been withdrawn from the market. The HighFocus I without positioner has been approved for use in the U.S. No Cochlear Limited or MedEl Corporation electrodes have a positioner.

Significant Events and Government Actions to Date

In early July, European and U.S. cochlear implant surgeons and experts met to discuss the incidence of meningitis occurring after cochlear implantation. That group concluded that there were more cases of meningitis with the CLARION device with the electrode positioner than with other cochlear implants. The organizers of that meeting recommended discontinuing use of the positioner, and the regulatory authorities of several European countries (e.g., France, Germany, and Spain) accepted those recommendations. Consequently, Advanced Bionics agreed to discontinue use of the positioner in those countries and is marketing one of their current electrode systems (HiFocus I) without the positioner. The company also initiated a voluntary recall of any unimplanted CLARION devices in the United States, but subsequently has received FDA approval for marketing the HiFocus I electrode without the positioner.

Drs. Noel Cohen (New York University) and Thomas Balkany (University of Miami) conducted a survey to ascertain additional cases of meningitis in cochlear implant recipients. They surveyed all North American implant centers. Their survey helped FDA identify cases of meningitis during the early course of this investigation.

The Centers for Disease Control and Prevention (CDC) and the FDA, in partnership with State Health Departments, are presently conducting a formal, comprehensive investigation into the apparent association between meningitis and cochlear implantation. The purpose of this investigation is to gather information that may help determine risk factors that lead to meningitis in this implant population and help to develop strategies to prevent meningitis in cochlear implant patients. This investigation focuses on implant recipients who were under the age of six at the time of implant.

Meningitis

Meningitis is an infection of the lining of the surface of the brain. Early symptoms of meningitis include fever, irritability, lethargy and loss of appetite in infants and young children. Older children and adults may also manifest headache, stiff neck, nausea and vomiting, and confusion or alteration in consciousness. Physicians are encouraged to consider a diagnosis of meningitis in cochlear implant patients when such symptoms exist and to begin appropriate diagnostic testing and treatment as soon as possible.

The younger patient population (< 5 yr) and the elderly are most vulnerable to meningitis.

Cochlear Implants and Otitis Media

In some of the reported cases of meningitis in cochlear implant recipients, patients may have had overt or sub-clinical otitis media prior to surgery or before the meningitis developed. Physicians are encouraged to consider appropriate prophylactic perioperative antibiotic treatment, and to diagnose and treat otitis media promptly in patients with cochlear implants.

Use of Pneumococcal Vaccinations for Cochlear Implant Recipients

Persons less than 2 years with cochlear implants should receive the pneumococcal conjugate vaccine according to the high risk pneumococcal conjugate vaccination schedule. This schedule is the same as the pre-shortage routine immunization schedule used for children less than age 2 years. For high risk infants who start the series before age 6 months, this means they would get four doses, given at 2 months, 4 months, 6 months and 12-15 months.

Persons who are age 2 years and older with cochlear implants should receive pneumococcal vaccines, according to the following schedule:

Use of Hib Vaccination in Cochlear Implant Recipients

Most children born after 1990 will have received the Hib vaccine when they were infants. http://www.cdc.gov/mmwr/preview/mmwrhtml/00041736.htm  Those who did not receive Hib vaccine and who are younger than five years should receive the vaccine. For those age 5 years and older, Hib vaccine is not routinely recommended.

The CDC National Immunization Program (NIP) has set up a hotline that will advise persons with cochlear implants to receive age-appropriate high-risk pneumococcal vaccinations. In addition, they will be able to answer questions related to immunization issues or refer calls to immunization experts at NIP if needed.

The Hotline numbers are:

The hotline is closed on weekends and federal holidays.

Reporting Cases of Meningitis in Cochlear Implant Recipients

We encourage you to report cases of meningitis in cochlear implant recipients. Please call 1-877-CDC-HEAR to report cases so that they can be included in the CDC-FDA study. You can also report cases directly to the device manufacturer or you can report them to MedWatch, the FDA's voluntary reporting program. You may submit reports to MedWatch one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/  by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

FDA Contact: Nancy Pressly
Office of Surveillance and Biometrics (HFZ-510)
1350 Piccard Drive, Rockville, Maryland, 20850
Fax at 301-594-2968, or by e-mail at  phann@cdrh.fda.gov 

Additionally, a voice mail message may be left at 301-594-0650 and your call will be returned as soon as possible.


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Last Revision: August 25, 2003