We received word a few days ago that the company that manufactures Natalie's implant issued a voluntary recall on the internal implant. The failure rate has been less than 1% since 2009 and so they issued a statement saying they noticed an increase in numbers of failure rate.
After talking with our audiologists, we just have to sit tight. Natalie may or may not be affected by this. There have been 75 reported cases and 2 of which, were at our audiologist office. We are not sure if it is a bad batch problem as they are still investigating the cause which could take months. The way we would notice, is Natalie's processor would not work correctly and after troubleshooting, nothing will work on it. It is not something painful or bothersome, it just stops working.
Since they were seeing an increase in failure rates, they decided to pull off the shelves in hospital any remaining internal implants until they can further find the cause of the increased failures. If Natalie were to have a bad implant, she would have to have surgery again and be re-implanted of the previous generation internal implant, while the external processor is still compatible. (hopefully she will not be affected by this recall and hopefully the failure rate is still around 1%.)
There are 3 companies that make CI's, and prior to this recall, they had the least amount of failure rates (and probably still do) and never had any major issues with recalls. I am still glad we went with them and am hoping they resolve and find this problem quickly. I am on a few online forums and have a good support group of moms so we definitely are watching out for each other.
Lets hope this princess doesn't have to have surgery again!
(e-mail below...)
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.
For more than 25 years, cochlear implant reliability has been of paramount importance to Cochlear, and we remain committed to providing high quality, high reliable cochlear implant systems.
