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Article: Advanced Bionics clarifies Clarion cochlear device issue.
- Article from:
- Medical Device Daily
- Article date:
- September 3, 2002
CopyrightCOPYRIGHT 2002 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Advanced Bionics clarifies Clarion cochlear device issue
By HOLLAND JOHNSON
Medical Device Daily Senior Staff Writer
Advanced Bionics (Sylmar, California) said that based on what it is hearing, the FDA does not have a great concern with cochlear implant products at this time it just wants to make patients and doctors aware of the potential risk of bacterial meningitis infection and to encourage a vaccination course to prevent such an outcome.
The FDA said in a recent public health notification that the exact cause of the infections has not been established, but that the design of an electrode used as part of the implant is being ...