Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AB HiResolution Bionic Ear System Recalled by Advanced Bionics, LLC Due to hearing performance degradation due to body-fluid entering the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Bionics, LLC directly.
Affected Products
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ 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.
Quantity: 8159 units (CI-1601-04 = 3827 units and CI-1601-05 = 4332 units)
Why Was This Recalled?
hearing performance degradation due to body-fluid entering the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Advanced Bionics, LLC
Advanced Bionics, LLC has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report