Advanced Bionics, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Advanced Bionics, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Numbers: CI 1601 04 - HiRes Ultra 3D with HF Mid-Scala Electrode CI 1601 05 - HiRes Ultra 3D with HF SlimJ Electrode Lot Numbers - 1000000 thru 1999999.
Advanced Bionics, LLC is recalling AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The d due to hearing performance degradation due to body-fluid entering the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
hearing performance degradation due to body-fluid entering the device.
Recommended Action
Per FDA guidance
On 02/17/2020, the firm sent an "Urgent Field Action Notification" via email to healthcare providers informing them that the firm has detected an increase in the number of devices being explanted or the potential of being explanted due to performance issues (impedance drop and reports of hearing performance degradation) resulting from fluid ingress at the electrode. The Healthcare Notification instructs Healthcare Providers to: 1. Provide registration information for all devices that have been implanted; 2. Return any unimplanted devices and to emphasize not to implant any of these units. The Healthcare Provider Notification also provided the Healthcare Provider with a Patient Management information that includes "Key Clinical Questions". For questions, contact the Recalling Firm at: In the United States: (877) 8290026 between the hours of 5:00 AM and 5:00 PM Pacific Time, Monday through Friday. Europe / Asia Pacific / Latin America / Middle East and Africa: Please contact your local Advanced Bionics office with any questions. On 02/17/2020, the firm sent an "Important Notification" to implant receipients via FedEx to inform implant users or parents/caregivers of the issue of prolonged hearing degradation due to physiological fluid entering into the electrode (not the hermetic seal of the device body) and causing interruption of stimulation that can negatively affect device performance. The notification also informed users that the firm, as a precaution, is removing from the market all the initial version of unimplanted device and states that the performance degradation does not affect the safety of the device but revision surgery may be necessary due to the performance decrease. The firm is informing patients/users: -They should continue to use your device as normal. If you experience a decrease in hearing performance over time, you should visit your Audiologist to have your hearing assessed to understand if there could be a potential issue with yo
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026