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www.tdh.state.tx.us/phpep/
TA.S STATE
Vol. 62 No. 22
Cochlear Implants and Meningitis
The Food and Drug Administration (FDA) has received reports of cases of people who have cochlear
implants contracting bacterial meningitis. In response to this public health concern, the FDA is
working with the Centers for Disease Control and Prevention (CDC) and state health departments
to investigate the association between cochlear implants and meningitis. This report describes the
results of anFDA survey of cochlear implant vendors, the risk factors for meningitis associated with
these implants, and the recommendations for reducing this risk.
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According to an FDA survey of
cochlear implant vendors, as of
November 2001, an estimated 70,000
people worldwide have received implants;
approximately 21,000 are people in the US.
Over a 14-year period, 52 cases of meningitis
in cochlear implant recipients have been
identified worldwide; 24 cases have been in
North America. The 52 cases have occurred
in children and adults ranging in age from 21
months to 72 years; 12 died from sequelae.
The time period for developing symptoms
and signs of meningitis ranged from within
24 hours of implantation to 5 years post-
implantation. Cerebrospinal fluid results are
available from 14 cases: Streptococcus
pneumoniae was the most common pathogen,
but Hemophilus influenza, Escherichia coli,
Streptococcus viridans and enterococcus species
have also been cultured.
To determine risk factors for meningitis
associated with cochlear implants, CDC is
planning a case-control study in collaboration
with the FDA and state health departments.
The target population is children younger
than 6 years of age who have received
cochlear implants. Information regarding
the type of implant, medical and surgical
history, age, gender, race, and ethnicity will
be collected from study participants and
analyzed for risk factors.
Potential risk factors are many. Congenital
deafness may increase baseline risk even prior
to implantation, and deafness secondary to
meningitis may increase recurrence risk.
Prior otitis media or immunodeficiency may
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also be predisposing factors. Additionally,
each of the three US manufacturers of
cochlear implants have different implant
designs, and it is possible that certain design
features increase risk for meningitis. Two
implant surgeons, Drs. Noel Cohen and
Thomas Balkany, surveyed the North American
cases: 9 cases were in patients with the
Advanced Bionics Corporation CLARION
device, 15 were in patients with the
Cochlear Nucleus Corporation device,
and none were among patients with the
MED-EL Corporation device.
Removal of cochlear implants is not recom-
mended at this time. Vaccination against
Streptococcus pneumoniae and Hemophilus
influenza may offer protective benefit for
cochlear implant candidates and recipients.
However, 3 of the meningitis cases developed
despite vaccination. At least one of the
cochlear implant manufacturers is offering
to reimburse for vaccination.
The Advisory Committee on Immunization
Practices (ACIP) recommends the following
schedule for vaccines against Streptococcus
pneumoniae and H. influenza:
Vaccination against H. influenza
" All children < 5 years old:
H. influenzae conjugate vaccine
series is recommended
Continued
t of Health
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