MED-EL Elektromedizinische Gereate, Gmbh recalls MED EL Cochlear Implant System, SONATATIi100, sold under the
Recalled Product
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
Hazard / Issue
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Issued by
FDA
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