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- Re: Warning Letter

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If you read the letter, you will find that it is not about the device

or product failure from what I have read. It seems to be an issue

about some clinics doing trials without getting the proper signed

paperwork from the people who participated in the trials before they

were done. I'm still waiting for more clarification on this but that

is what I read from the PDF warning letter.

I expect to hear back from Cochlear on this sometime tomorrow.

Alice

http://www..com

>

> I saw the PDF file on the FDA warning letter to Cochlear. I was

quiet shocked that they had gotten the letter. I thought they were a

really good company. What happened?

>

> A. Tucker

> CI Candidate

> Surgery: 5/18/07

> Activation: Mid June

>

>

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