Advanced Bionics, LLC recalls AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electr
Recalled Product
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Hazard / Issue
hearing performance degradation due to body-fluid entering the device.
Issued by
FDA
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