HiRes 90K Cochlear Implant Device Recalled

Washington, DC: Advanced Bionics (AB), has notified the US Food & Drug Administration (FDA) that it will recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution.

This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

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Published on Nov-25-10