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2014

With No Documented Reports of Meningitis, MED-EL Responds to the Recent FDA Announcement Regarding a Possible Link Between the Illness and Cochlear Implantation

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    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
 (http://www.fda.gov/cdrh/safety/cochlear.html).
     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.
 
     Contact:
     Valerie Dally
     MED-EL Corporation, N.A.
     (888) 633-3524 x 3002
     vdally@medelus.com
 
 
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X31627641
 
 

SOURCE MED-EL

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