About the 2004 Study
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Background
The study completed in 2002 found that bacterial
meningitis occurred more often in children with any type of cochlear
implant than in children of the same age group in the general population
who did not have cochlear implants. The group of children that was
studied in 2002 had cochlear implants for two years or less at the time
the study was conducted. After the 2002 study was finished, the Food
and Drug Administration (FDA) continued to receive reports of bacterial
meningitis in children who had cochlear implants. Some of these
children got meningitis more than two years after they first received
their cochlear implant. The researchers wanted to know if the increased
risk of bacterial meningitis continued more than two years after
cochlear implant surgery.
Conducting the study
The 2004 study was conducted similarly to the 2002
study. The same group of children was studied in both the 2002 and 2004
investigations. When information was collected for the 2004
investigation, the children were older and had had their implants in
place longer than they did during the 2002 investigation. Potential
cases of bacterial meningitis in these children were identified from the
FDA Adverse Events Reporting System. The researchers also asked the
implant manufacturers and CDC, state, and local health department
tracking systems about cases of meningitis that were reported to them,
however, no other cases were found. The researchers learned more about
these cases from the medical records of hospitalizations for meningitis.
Study findings
The study found that even two years after implant
surgery, children with cochlear implants with a positioner were at
greater risk of developing bacterial meningitis than children in the
general US population. 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, and none were
implanted after July 2002.
Recommendations
Home
| About the 2002 Study |
About the 2004 Study |
Recommendations |
Questions and Answers | Resources (pdf)
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Date:
October 27, 2006
Content source: National Center on Birth Defects and Developmental
Disabilities
