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Cochlear™ Recalls CI500 Device

September 12th, 2011 by | Tags: , , | 5 Comments »

The latest news reports from Australia confirm that Cochlear™ has voluntarily recalled its CI500 internal implant (the internal component to the N5 system).  No details on what caused the recall or how long it is expected to last.  Stay tuned to Cochlear Implant Online for updates as the story unfolds.

UPDATE 9/11/2011 8:15PM CST:  Some are reporting that patients scheduled to receive Cochlear™ CI500 implants during the recall period may receive Nucleus Freedom internal devices (the previous implant generation), which are fully compatible with the N5 processor (which has not been recalled).  Consult your CI surgery center for details.

 

UPDATE 9/11/2011 8:20PM CST: Confirmed –Cochlear™’s Nucleus® Freedom internal implants will remain on the market and continue to be available for those awaiting implantation with Cochlear™ Nucleus® implants.  See Cochlear press release below.

News articles about the recall:

Written by

Elizabeth Rosenzweig MS CCC-SLP LSLS Cert. AVT is a Listening and Spoken Language Specialist Certified Auditory Verbal Therapist. She provides auditory verbal therapy, aural rehabilitation, IEP advocacy, consultation, and LSLS mentoring for clients around the world via teletherapy. You can learn more about Elizabeth's services on her Website or Facebook.

5 Comments

stacey

September 17, 2011 at 8:38 pm

my mother was the recipient which caused the recall to happen as she was the 12th user to have the implant to suddenly stop working. She has now got to have the operation again and she has lost complete faith in the company.

Mark

October 1, 2011 at 12:31 pm

I’m a parent of a very recent bilateral implant child and we’ve just had one device not registering as connected tonight. Nervous wait until we can get it checked. Is there any more info from the company as they seem to have gone quiet.

October 10, 2011 at 10:52 am

[...] Cochlear announced a voluntary recall of its CI500 (N5) internal device.  The cause of the recall was shortly after announced to be due to moisture issues within the implant (not a hermeticity/sealing breach).  Surgery candidates currently slated to receive Nucleus devices have the option of receiving a Freedom internal device, which is compatible with the N5 external processor. [...]

December 5, 2011 at 2:19 am

Hello guys!

My name is Paul, I am 25 years old and in towards the end of April 2011 (27th) I was implanted with the N5 implant (C1512) in my left ear. (activated 26th may 2011) totally loved it until the end of October 2011 time.
I told my audie up london and she told me to come up for an Integrity test performed by Cochlear and the news that I feared became true and the batch that was involved in the C1500 series implant failures was indeed the batch that was implanted in me.
but on the good side of things (despite the further operation) I will be admittted to hospital on thursday 8th December 2011 to be reimplanted with Freedom. gutted to say the least but I know that it obviously was no-one’s intentional fault not even Cochlear’s its just one of those things that happen I guess.
Cannot wait until new year 2012 when I willl be reactivated and I will have my hearing back :D

regards

Paul Toovey
London, UK

Jason spadola

September 11, 2013 at 2:51 pm

I am totally disappointed I don’t know why the FDA
Has not approved the bionic ear from France
A company with no recalls.if you live in USA cochlear
Is your only choice.i am not being reimplanted I have
No trust in cochlear recall after recall

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