Following reports of performance issues, Advanced Bionics has issued a voluntary field corrective action for HiRes Ultra cochlear ear implants.
In a statement released on March 10, Advanced Bionic began notifying regulatory agencies of its need to address a decrease in performance for HiRes Ultra and Ultra 30 cochlear implant devices.
Cochlear implants are an alternative to hearing aids surgically implanted in the inner ear. The implant bypasses the normal acoustic hearing process and replaces it with electrical signals that directly stimulate the auditory nerve. The user can be trained to interpret those stimulations as sound and speech.
When the device doesn’t function properly it does not produce the proper electrical signals to stimulate the auditory nerve.
According to Advanced Bionics, more cochlear implant patients have been having the devices removed in recent months, indicating they are not operating as they should. Reports of problems often involve performance degradation.
Some patients have also experienced fluid ingress at the electrode, leading to interruption of stimulation. However, the hermetic seal of the implant case has been shown to be intact.
As of Feb 11, more than 16,000 recipients have explanted the device for this reason, a revision rate of about 0.5%.
No injuries or deaths have been reported in connection to the problem. The only risk related to the issue is if a patient undergoes revision surgery and suffers surgical complications.
Current recipients of the cochlear implants can continue to use the devices as normal. If a recipient experiences hearing degradation they should visit their audiologist or other health care provider.
Advanced Bionics has developed a new version of the implant to address the performance issues. The company says it will begin to issue notifications to implant recipients worldwide, alerting them to the potential performance problems.