With No Documented Reports of Meningitis, MED-EL Responds to the Recent FDA Announcement Regarding a Possible Link Between the Illness and Cochlear Implantation
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 firstname.lastname@example.org MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X31627641
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