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Background on the Advanced Bionics Cochlear Implant Recall
On February 17, 2020, Advanced Bionics sent an "Urgent Field Action Notification" to healthcare providers informing them that Advanced Bionics had detected an increase in the number of devices being explanted or the potential of being explanted due to performance issues, which included reports of hearing performance degradation, amongst other things.
The Advanced Bionics Cochlear implants are intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
These device failures were reported by Advanced Bionics as resulting from fluid ingress at the electrode leading to interruption of stimulation.
Health Canada posted the Advanced Bionics Recall on April 17, 2020. According to Health Canada: “The defect was discovered during the device failure analysis on an explanted device in March 26, 2019.”
What Impact will the Recall have on me or my child?
Defective devices may require surgical explantation and replacement.
Over 1/3rd of one institution’s patient population underwent explant surgery. According to the Laryngoscope Journal, “Advanced Bionics HiRes Ultra and Ultra 3D Series Cochlear Implant Recall: Time Course of Anomalies”, published in May 2022:
Of the 349 devices implanted at this institution, 181 showed anomalies in accordance with the special failure mode and for this reason, 120 implants were already explanted.
In the Journal of Otology and Neurotology, “Voluntary Field Recall of Advanced Bionics HiRes Cochlear Implants: A Single-Institution Experience”, published on October 6, 2022, the authors concluded:
Hearing performance degradation is significant in AB Ultra device failures and seems to be linked to the basal-most electrodes in the array. Revision outcomes have been robust, necessitating continued monitoring of affected patients and support for reimplantation procedures.
The Paediatric Population is at Risk
The largest single demographic for cochlear implants in Canada are children. The Canadian Agency for Drugs and Technologies in Health reported:
- Since the approval of these devices by Health Canada in 1990, there has been a steady increase in the number of implantations across all age groups in Canada
- Up until 2007, 4,244 Canadians had received implants; 2,534 adults and 1,710 children
- As of May 2011, approximately 2,100 to 2,350 children between the ages of zero and 18 years have received cochlear implant surgery in Canada
- These devices are implanted most frequently in children under the age of eight
- Several jurisdictions indicated the age ranges of 12 to 18 months and 12 to 24 months as the most common ages for surgical implantation
Cochlear Implant Class Action Lawyers
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