Monday 5 March 2012: Cochlear have released an update in regards to their Cochlear Nucleus 500 series:

"As of January 31st, 2012, the overall proportion of Nucleus CI500 series devices that has been reported as failed is 2.4% of registered devices globally. The number of newly reported device failures each month has decreased every month since October 2011.

For the devices that failed, the average time to failure after implantation was 7 months (90th percentile 12 months). Of the 97.6% of devices that have not failed, the majority (>85%) have been implanted for longer than the average time to failure. These data cannot be used to predict future failures.

Of the 2.4% of devices that have failed, two thirds were manufactured in the first quarter of 2011. Of the devices that have not failed from this manufacturing period, the majority (>75%) have been implanted for longer than the average time to failure of 7 months. Clinically the symptoms experienced prior to failure continue to be consistent i.e. a period of intermittency followed by the implant shutting down. Unless symptoms are present it is not necessary to treat patients with devices manufactured in the first quarter of 2011 any differently to ... current clinical management."

ENDS 

Wednesday 21 December 2011: Cochlear has announced they can now provide further information about the root cause of the problem associated with their Cochlear Nucleus 500 series, which was voluntarily recalled in September this year.

The root cause of the problem relates to unexpected variations in the brazing process of the device during manufacture. Cochlear state that specific microelectronic components malfunctioned in certain units because microcracks had allowed water molecules to enter the implant. The overall proportion of C1500 units that failed was approximately 1.9% of registered devices globally. There were fewer reported failures in November 2011 than in October 2011, and we will continue to closely monitor any changes in device function.

This understanding of the root cause forms the basis of a plan by Cochlear for the return of the CI500 series implant.
 
The Shepherd Centre continues to fully support Cochlear as the chosen manufacturer for our implant program. We remain confident in Cochlear's implants, processors and support they provide. The Shepherd Centre have been kept fully up-to-date by Cochlear since the initial recall was announced.

Should you have any concerns regarding this recall, or your child's device, please contact The Shepherd Centre on 02 9351 7883.

For full information, and to access a frequently asked questions and answers section on the issue, please visit the Cochlear website:

http://www.cochlear.com/au/cochlear-CI500-series-recall