FDA Public Health Notification:
Cochlear Implant Recipients may be at Greater Risk for Meningitis
Editor: You're probably aware that the Food and Drug Administration
(FDA) and the Cochlear Implant (CI) manufacturers have been
investigating the connection between CIs and meningitis. Initial
indications were that only the Clarion CI with positioner was affected
and that the meningitis risk was only slightly higher than the risk to
the general public. It's now looking like all CIs might be implicated
and the risk may be greater than previously thought. In addition, the
notification indicates that some people contracted meningitis after
taking the vaccine.
Here are portions of the updated notification from the FDA. The full
notification is available at:
http://www.fda.gov/cdrh/safety/cochlear.html
http://www.fda.gov/cdrh/safety/cochlear.pdf
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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 (2 case). A total of 17 deaths
have resulted from these meningitis cases.
Within the U.S., 53 cases of post-implant meningitis have been
reported by the three manufacturers; 5 cases resulted in death. Advanced
Bionics Corporation has 29 U.S. cases of post-implant meningitis since
receiving FDA approval in 1996. Cochlear Limited has 22 U.S. cases of
post-implant meningitis since receiving FDA approval in 1985. MED-EL
Corporation has 2 U.S. meningitis cases since receiving FDA approval for
their device in 2001. According to information supplied by the
manufacturers, the 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.
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.
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:
English 1-800-232-2522 (M-F, 8a -11p)
Spanish 1-800-232-0233 (M-F, 8a-11p)
TTY 1-800-243-7889 (M-F 10a-10p)
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
- 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
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.
