July 31, 2003
Cochlear’s highest priority has always been the safety of our recipients.

The Center for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and others published in the New England Journal of Medicine on July 31 2002 a study relating to cochlear implants and meningitis. The report is the result of a study that followed an awareness of meningitis in cochlear implant recipients, and the withdrawal in July 2002 of a competitor’s implant device with positioner.

The purpose of the study was to establish the incidence of meningitis among children with cochlear implants and to identify specific types of devices, surgical factors and patient characteristics that might be associated with an increased risk of bacterial meningitis among children with cochlear implants.

Today’s report (July 2003) is consistent with an earlier exhaustive review undertaken of Cochlear’s Nucleus implant system by independent medical professionals. The New England Journal of Medicine study confirms the following:

• Children who received a cochlear implant with a positioner were much more likely to get bacterial meningitis than children with other types of cochlear implants.
• Children with a cochlear implant who had congenital inner ear malformations or in association with cerebrospinal fluid leaks were at increased risk for bacterial meningitis.

Cochlear’s Nucleus implant system does not, and has never, included a positioner.

Based on these conclusions and the findings of our earlier independent review, we remain confident about the safety and design of Nucleus products.

The study confirms there is no evidence that implantation of a Nucleus device increases the long-term risk of post-operative meningitis.

Cochlear’s system retains full commercial approval for implantation in children as young as 12 months in the US, Europe and Asia.
Cochlear is committed to the well being of our implant recipients.
Cochlear Limited is the worldwide leader in cochlear implant technology.

For specific questions, please contact you physician

Or e-mail us at Recipients@cochlear.com

Or contact your regional Cochlear office.

Denver, Colorado USA: 1 (800) 523-5798
Basel, Switzerland: +41 - 61 - 205 04 04
Sydney, Australia: +61 - 2 - 9428 - 6555