Devices

Device Recall Harmony HiResolution Bionic Ear system

Model / Serial
Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.
Product Classification
Ear, Nose, and Throat Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution -- US, Canada, France and South Korea.
Product Description
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.
Manufacturer
Advanced Bionics LLC
1 Event
- Recall of Device Recall Harmony HiResolution Bionic Ear system

Manufacturer

Advanced Bionics LLC

Manufacturer Address
Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
Manufacturer Parent Company (2017)
Sonova Holding Ag
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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