Device Recall Harmony HiResolution Bionic Ear system

Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.

Ear, Nose, and Throat Devices

3

Yes

Worldwide Distribution -- US, Canada, France and South Korea.

Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. || Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.