Cochlear

November 2011

 This is an update on the recent voluntary recall of the unimplanted Nucleus CI500 Series cochlear implant range.  

Since the recall we have continued our intensive investigation into the root cause of the failures and now know that when a device fails it is due to the malfunction of specific electronic components associated with the receipt and management of information and power from the sound processor. When these components malfunction the implant shuts down. 

It is important to note that all existing Nucleus CI500 Series implant recipients can continue to use their system as normal. The Nucleus 5 Sound Processor (Nucleus CP810) and any previous generation sound processors are not affected by this recall. 

No implants outside the Cochlear Nucleus CI500 range are affected by this voluntary recall including Nucleus CI24RE and Nucleus CI422 cochlear implants which remain available. 

In the event of a failure, recipients can be re-implanted with the Nucleus CI24RE implant. The Nucleus CI24RE implant is fully compatible with the Nucleus 5 Sound Processor System.  

For people considering a cochlear implant, Cochlear recommends the use of the Nucleus CI24RE Series implants.  These implants are fully compatible with the Nucleus 5 sound processor and Remote Assistant.  This combination of the Nucleus CI24RE implant and Nucleus 5 Sound Processor offers the same performance, aesthetic and upgrade benefits as the Nucleus 5 System.

Cochlear remains as committed as ever to our recipients, our professional partners and our long term mission of bringing hearing to people around the world.

If you have any questions regarding this please do not hesitate in contacting your local Cochlear office.

Information for Cochlear Implant Recipients

Updated November 2011

Question - I have a Nucleus CI512 implant should I have it explanted?

Answer – No. There is no need to have your working implant explanted and you should continue to use your system as normal. 

Question – How will I know if my implant is failing?

Answer – In all implants that have failed to date, recipients experienced intermittency or no sound prior to failure. It is important to note that if you experience intermittency or no sound it is possible that this may be associated with your sound processor or programming issues and not necessarily an indication that there is a problem with the implant. You should follow the normal sound processor troubleshooting process to identify any problems with the sound processing unit, coil, cables, batteries or whether the microphone protectors require changing. In the event these steps do not solve the issue, you should contact your clinic.

Question - How do I know if I have a CI500 Series implant?

Answer – If you or your child has used or continues to use a Nucleus Freedom^TM, SPrint^TM or an ESPrit^TM 3G Sound Processor you will most likely not have a CI500 Series implant.

You may have received a Nucleus CI500  Series implant if you received a Nucleus 5 System. Your clinic will be able to confirm your implant type.

The following implants are not affected by this recall, the Nucleus Freedom range (RE CA, RE ST), the Hybrid L24 electrode, the Nucleus CI422 slim straight electrode, the CI24 R CA, CI24 R ST, CI24 R CS  the Nucleus 24M double array or the Nucleus ABI 24M.

Question – What happens if my or my child’s implant fails.

Answer –If your implant fails then you should contact your clinic. The implant is covered under normal warranty conditions and can be replaced with a Nucleus CI24RE implant. The Nucleus CI24RE implant is fully compatible with the Nucleus 5 Sound Processor system. This combination of Nucleus CI24RE and Nucleus 5 sound processor system provides the same performance benefits of the Nucleus 5 system. 

Question – I have upgraded to a Nucleus 5 Sound Processor, am I at risk of implant failure?

Answer – No, the voluntary recall relates to the unimplanted CI500 series implants only.  No sound processors or previous generation implants are subject to the recall.

Question – Are there any functional differences between the Nucleus CI500 and Nucleus CI24RE Series implants?

Answer – No.  While the design and manufacturing process between the implants are different, the functionality of both is the same. Because the Nucleus CI24RE implant is functionally the same the combination of Nucleus CI24RE and Nucleus 5 Sound Processor (CP810) provides the same performance benefits of the Nucleus 5 system.