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Cochlear HiRes Ultra Ear Implant Problems Lead To Field Corrective Action

  • Written by: Martha Garcia
  • 2 Comments

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.

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2 comments

  1. Frank Reply

    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.

  2. James v Reply

    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.

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