Cochlear Implant Recall: Frequently Asked Questions
August 2, 2008 · Print This Article
What cochlear implants are affected by this recall?
The Advanced Bionics HiResolution 90k (HiRes 90k) from Supplier B. Advanced Bionics has chosen not to recall devices that have been implanted into patients.
Why is this recall taking place?
Advanced Bionics voluntarily recalled certain HiRes90k cochlear implants that have NOT been implanted because of an elevated risk of device failure because of moisture-related issues. Advanced Bionics removed unimplanted devices from hospital inventory.
Will any upcoming cochlear implant surgery be affected by the recall?
No, as the recall affected only unimplanted HiRes 90k cochlear implants. At the time of the recall, Advanced Bionics assuired that all HiRes90K devices manufactured with the particular component from Supplier B were removed from hospital inventory and have shipped only devices that had been manufactured by Supplier A
What are the symptoms of a moisture related device failure?
As reported by Advanced Bionucs, “The predominant symptom for implants that experience a moisture-related malfunction is loss of lock (inability for the internal implant to accept communication from the external headpiece) resulting in no sound perception. This is commonly preceded by a period of intermittency (sound going on and off), or the perception of an overly loud sound. There are other potential reasons for these types of symptoms, including external equipment malfunction (processor, microphone, headpiece, cable); therefore, we recommend that you follow routine troubleshooting procedures and if concerns remain, please consult your implant center.”
Does the recall affect patients with no symptoms?
Per Advanced Bionics, if a patient has no symptoms, the recall does not affect the patient, and no action is required on the patient’s part.
Did the FDA require Advanced Bionics to issue this recall?
No, Advanced Bionics voluntarily issued the HiRes90K recall.
My son was implanted with one of the devices that was recalled. It was his second ear implanted on July 5th 2005. We had no problems with the first ear back in 2004 but not so with the second. By the end of the year my child had completely SHUT DOWN. His device didn’t just stop working. We tested it over and over and advanced bionics said that it was working and so we continued to make him wear it. Everyday just got worse, he was no longer communicating AT ALL, he became non- sociable and lost his loving personality. It was like he completely withdrew himself from everything. We were seeing specialists and many doctors (worried about autism) but no one could give us answers. My husband and I finally decided to take off his recalled implant, two weeks later he started communicating again. We had to start over like we were back to day one activation. We finally convinced advanced bionics that it was the device after our audiologists did some testing of the device on her own. Then they responded with DO NOT PUT IT BACK ON HIM. Then we had to work with them and got them to agree to pay for the reimplantation in FULL. My insurance was not going to pay for a third implant. We received another advanced bionics implant on October 10th 2006. We have had no problems with the new one and my child is still working to try to get caught up. It was a long struggle and was very heartbreaking to watch my child regress like he did. He was only three at the time. The clinic were we receive care has had many more failures since our son. In most cases their devices just stopped working but not for my son. We still to this day do not know what was happening to him while he was wearing the device. All we know is that he was having some type of discomfort with it but we do not know to what degree. I will pray that your grandson doesn’t ever have to go through what my son did. God Bless your Family