Cochlear HiRes Ultra Ear Implant Problems Lead To Field Corrective Action
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.
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Learn MoreWhen 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.
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3 Comments
CraigApril 13, 2022 at 8:19 pm
I woke up deaf ten years ago, and my audiologist at Iowa University Hospital suggested an Advanced Bionics cochlear implant. 1. The first model, a Q70, was defective and was the last of a discontinued product — yet they sold it to me anyway and admitted this three years later after many product failures and many emotional breakdowns. 2. The sound was maddening for seven years until “they dis[Show More]I woke up deaf ten years ago, and my audiologist at Iowa University Hospital suggested an Advanced Bionics cochlear implant. 1. The first model, a Q70, was defective and was the last of a discontinued product — yet they sold it to me anyway and admitted this three years later after many product failures and many emotional breakdowns. 2. The sound was maddening for seven years until “they discovered” that they had to disconnect a certain electrode. They seemed to know about this for a while before they told me. I only found out about it because I was there for a CI research project. 3. Mostly AB has really, really has horrible customer service. I can’t use a phone, so it’s frustrating to email them that my CI is on the fritz and I can’t hear—yet it takes them days to answer back. Going deaf overnight and having one’s life turned cartwheels caused enough PTSD—it’s aggravated again when I can’t get help from the company who put an implant in my skull. I don’t know how to compensate for eleven years of deception, stress, and lousy customer service for someone who depends,on their product for hearing…
James vSeptember 26, 2020 at 4:27 pm
I had cochlear implant in January 2016 and the implant worked for 3 months and quit working. Cochlear refused to respond to my complaints. In January 2018, I got opinion from top E-N-T chief of surgery at national known medical hospital and was told by this person that the Surgeon installed the wrong implant and failed to clean out the debris he left in my head. I recently had Quadruple Heart BYp[Show More]I had cochlear implant in January 2016 and the implant worked for 3 months and quit working. Cochlear refused to respond to my complaints. In January 2018, I got opinion from top E-N-T chief of surgery at national known medical hospital and was told by this person that the Surgeon installed the wrong implant and failed to clean out the debris he left in my head. I recently had Quadruple Heart BYpass due to worrying about the damn metal left in my head that does not work. COCHLEAR REFUSES TO RETURN CALLS OR DEAL WITH ME.
FrankSeptember 16, 2020 at 6:19 pm
I had terrible side effects after the surgery. Terrible pounding in the ear for days, finally went into a severe anxiety reaction due to the noise. It was terrible. My doctor said no one has those side effects and the only recommendation he could make was to remove the implant! I found another doctor.