RESEARCH TRIANGLE PARK, N.C., July 29 /PRNewswire/ -- MED-EL, the second
largest manufacturer of cochlear implants, formally states that they have no
documented reports of post-operative meningitis among users of the MED-EL
Cochlear Implant System. This statement is in response to a recent
announcement by the Food and Drug Administration (FDA) regarding a potential
risk of post-operative meningitis in patients with cochlear implants
On July 2nd, MED-EL reported to the FDA that they had reviewed patient and
complaint databases and contacted all clinical support staff as well as
clinics using MED-EL systems worldwide. MED-EL confirmed to the FDA that they
have no documented reports and that the company is not aware of any cases of
post-operative bacterial meningitis among MED-EL implant users. This
information was reflected in the FDA Public Health Notification issued on July
24th. MED-EL will remain vigilant in respect to this important issue.
The MED-EL Cochlear Implant System features a unique single-branch soft
electrode array designed for atraumatic insertion and a sound cochleostomy
seal. MED-EL believes that patients will benefit most from electrodes that
preserve the delicate cochlear structures while allowing deep insertion for
coverage of the entire cochlea.
MED-EL Corporation received FDA approval for the COMBI 40+ Cochlear
Implant System in August 2001. MED-EL cochlear implants are currently used in
over 60 countries worldwide.
MED-EL is committed to providing safe, high quality, highly reliable
cochlear implant systems for cochlear implant users and candidates worldwide
and to working in partnership with professionals to ensure that users receive
the greatest benefit from their implants.
MED-EL Corporation, N.A.
(888) 633-3524 x 3002
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