Friday, September 23, 2011

Nucleus 5 Voluntary Recall

Friday September 16th, just 9 days after Malachi had received his first cochlear implant I received what felt like a devastating email from Cochlear. It read:

"As a valued member of the Cochlear™ Community, we would like to thank you for partnering with Cochlear for your hearing journey, and supporting others in the Community. You may have recently learned of the Cochlear Limited voluntary recall of the Nucleus® CI500 series cochlear implant. We would like to provide you the latest information regarding this announcement, and assure that you, or your child, can continue to safely hear and use your cochlear implant system."

I simply was shocked beyond believe. How in the world was this possible?

This is the announcement at

"Cochlear Limited is undertaking a voluntary recall of the unimplanted Cochlear Nucleus CI500 cochlear implant range.

While less than 1% of CI512 implants have failed since launch in 2009 , Cochlear has identified a recent increase in the number of Nucleus CI512 implant failures.   In an abundance of caution and with our recipients in mind, Cochlear has issued a voluntary recall of the Nucleus CI500 range of cochlear implants while it further investigates the issue.

No implants outside the Cochlear Nucleus CI500 range are affected by this voluntary recall including Nucleus Freedom implants which remain available.

The Nucleus 5 external devices (Nucleus CP810 Sound Processor) and any previous generation sound processors are not affected by this recall.

It is important to note that all existing Nucleus CI512 implant recipients can continue to use their system as normal. 

If a Nucleus CI512 failure occurs, the implant safely shuts down.  In the event of a failure, recipients can be re-implanted with the Nucleus Freedom implant range which remains available.  Nucleus Freedom is fully compatible with the Nucleus 5 Sound Processor System which is not affected by this recall. 
For people considering a cochlear implant, Cochlear recommends the use of the Nucleus Freedom range of Cochlear implants which are fully compatible with the Nucleus 5 sound processor system.  This combination of Nucleus Freedom and Nucleus 5 sound processor system does not sacrifice any of the performance benefits of the Nucleus 5 processor system."

So what are we going to do? The following Monday I contacted Malachi's audiologist. She had only briefly heard about it a day before we did and at that point didn't know anymore than us. Basically, what will happen for Malachi is that he will still get his external processor Nucleus 5 (the part that looks sort of like a hearing aid) for his left ear. But when it comes time (Oct 12) to implant his right ear, he won't get the Nucleus 5 internal implant. They will give him the Freedom which is the Nucleus 5's predecessor. It's still a fantastic implant and will work with the Nucleus 5 external processor. So inside his head he'll have two different but very similar internal implants. But on the outside he will have two Nucleus 5 external processors. I hope that makes sense to everyone :)

At first I cried and cried. I so upset. But since then I have calmed down and realized this is one of the risks we were willing to take. The processor still has a 99% of succeeding. Really the only difference between the Freedom and Nucleus 5 was the size, but i think the Nucleus is something like 25% smaller. Not extremely noticeable. I'll keep you updated as we learn more. :)

1 comment:

  1. I know this is an old post but I relate to this greatly because the same exact thing happened to us. We found out 1 week after getting my now 3 year old son's first CI implanted that it was recalled. We thought we had the similar 99% that it would work fine which it did for 2 years. Friday after doing hours of testing because the light would just stay the slow orange blink, we found out it is a failed device. It was devastating to find out. We thought there had been enough time and we were in the clear but I guess not. Now we are planning another surgery. Also, as more research has been done and more time passed they've realized the fail rate is not like 10%.