Advice for Patients with Cochlear Implants: New
Information on Meningitis Risk
Editor: You may recall that several years ago the recipients of some
cochlear implants were found to be at increased risk for contracting
meningitis. At that the FDA came out with several recommendations,
including vaccinations for CI recipients. Now we learn that not everyone
took this advice to heart, and that two CI recipients have died from
meningitis in the past year.
Here's the latest info from the FDA.
Source: http://www.fda.gov/cdrh/medicaldevicesafety/atp/101007-cochlear.html
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October 2007
New Information on Meningitis Risk
* Two cochlear implant patients recently died from infections. Neither
one was fully vaccinated. One of these two likely died because of the lack
of vaccination.
* A survey of parents of cochlear implanted children showed nearly half
of them did not know whether their child had been fully vaccinated.
This Advice for Patients is to remind you of the increased and
life-threatening risk of bacterial meningitis in cochlear implant patients
and the importance of their being fully vaccinated.
Cochlear implant patients appear to be at some increased risk of
bacterial meningitis caused by Streptococcus pneumoniae. However, those
children implanted with cochlear implants with a positioner component are
at greatest risk. This particular model of cochlear implant is no longer
being manufactured and was withdrawn from the market in July, 2002.
Recommendations
* Review your child's immunization records with your doctor to assure
that all the proper vaccinations have been given.
o Check the patient's record of vaccinations against Center for Disease
Control and Prevention's (CDC) recommendations that show what vaccines
cochlear implant patients should receive and when the vaccines should be
given.
o Go to CDC's website for vaccination recommendations:
(http://www.cdc.gov/vaccines/vpd-vac/mening/cochlear/dis-cochlear-gen.htm)
* Continue close monitoring for meningitis and middle ear infections
for all children with a cochlear implant.
o There is an increased risk if your child's implant has a positioner.
o Consult your implanting doctor if you are not certain if your child's
cochlear implant has a positioner.
* Contact your doctor immediately if the patient has any symptoms of
meningitis or middle ear infection. These may include:
• high fever
• discomfort looking into bright lights
• headache
• sleepiness or tiredness
• stiff neck
• confusion
• nausea
• ear pain
• vomiting
• hearing loss
• irritability
• appetite loss
* Remind your doctor that your child has a cochlear implant.
* Follow your doctor's prescription for antibiotics very carefully. It
is very important that the patient takes the antibiotic as often and for
as long as prescribed, so it can work properly.
* Contact the CDC Immunization Center for any questions or information
you may need. That telephone number is 800-232-4636. The TTY number is
888-232-6348.
New Information
FDA has become aware of two deaths from meningitis within the past year
in children implanted with the Advanced Bionics cochlear implant with
positioner.
* Neither of these children was fully vaccinated, according to the CDC
recommended vaccination schedule.
* These children, ages 9 and 11, had completed only part of the
recommended two-stage vaccinations for pneumococcal disease for their age
group (Under two years for the first stage and over two years of age for
the second stage.)
* At least one of these children had meningitis caused by a serotype of
Streptococcus pneumoniae that may have been prevented by full vaccination.
Dr. John Niparko of the Johns Hopkins University recently conducted a
survey on the University's cochlear implant patient population.
* The survey showed that 29% of the parents/guardians of patients under
2 years of age were uncertain if their child had both levels of
vaccination to prevent meningitis.
* In patients greater than 2 years of age, vaccination status was
unknown for 43% of the patients while 12% of the patients were shown not
to be properly vaccinated.
* This is in spite of repeated information bulletins about the
importance of vaccination to reduce the risk of this life-threatening
infection.
FDA is working with the CDC and professional societies to alert parents
to the importance of vaccinations in the cochlear implant population.
Previous Information
* A study published in the New England Journal in 2003 by FDA and CDC*
followed children with cochlear implants for two years after the device
was implanted.
o The study showed that children whose implants have a positioner get
bacterial meningitis more often than children with implants that don't
have positioners or children without implants.
- A positioner is a small rubber wedge that helps the physician position
the implant during surgery.
- Only Advanced Bionics Corporation sold an implant that had a positioner.
None were implanted after July 2002.
o Bacterial meningitis, a serious infection in the cerebrospinal fluid (CSF)
around the brain and spinal cord, can be fatal.
o The source of this study is (NewEngJMed, 349.5: 435-445) or http://content.nejm.org/cgi/content/full/349/5/435
* In a February 2006 FDA and CDC published a study report in
Pediatrics, titled "Bacterial Meningitis Among Children With Cochlear
Implants Beyond 24 Months After Implantation" that
o followed the children for two more years
o found that the increased risk for meningitis continued beyond two years
after implantation
o highlighted the importance of continuing to monitor children with
cochlear implants for signs of middle ear infection and meningitis.
o emphasized that children need to be monitored for as long as the implant
is in place
o The Pediatrics study is located at: http://pediatrics.aappublications.org/cgi/content/abstract/117/2/284
Additional Background Information
*The original CDC/FDA study (2003)
* reviewed the medical records of 4,264 children under the age of six
at the time of they received their implants
* was conducted because of increased concern about the risk of
meningitis associated with cochlear implants
* focused on young children because they
o account for most known meningitis cases
o represent the population that now receives a large proportion of
cochlear implants
In the original study, 26 of the 4,264 children developed meningitis
during the first 24 months after receiving their implants. Children who
had cochlear implants with positioners developed meningitis more often
than children who had implants without positioners. The study was unable
to determine how the positioner increased the risk for developing
meningitis.
Because the number of meningitis cases in the original study was small,
it is hard to predict the risk of developing meningitis with various
cochlear implant models. The study also concluded there is not enough
information now to recommend surgical removal of devices with a positioner.
Information for caregivers/patients with cochlear implants appears on
the web at http://www.fda.gov/cdrh/medicaldevicesafety/atp/020606-cochlear.html.
Information for health care providers appears on the web at http://www.fda.gov/cdrh/safety/101007-cochlear.html.
For general information on cochlear implants visit:
http://www.fda.gov/cdrh/cochlear/
