A Letter to Med-El from Bob - Transparency and Truth Appreciated..........

[Guest guest]

FYI dear all !

Bob

FDA Warning Letter of December 16, 2004

> Dear Med-El:

> > I have not seen any mention on the Med-El website of the FDA warning letter

as referenced. Is

this

> not a matter that would be of interest to Med-El patients, potential and

present as well?

>

> I believe it would be in Med-El's best interest, as a respected manufacturer

of cochlear implants,

> to be forthright, and not be withholding in report of your unfortunate

temporary difficulties.

>

> When Advanced Bionics encountered similar reliability issues secondary to

compromise in

> hermeticity, they voluntarily recalled the product.

>

> The matter was resolved, and all was well again.

>

> And the entire issue, from beginning to end, was made available to the press,

in releases, which I

> monitor, and on the AB website, for all to see.

>

> And I believe it to be imperative that Med-El should follow that same

admirable course of

> transparency and truth in the following:

>

> a: A general press release , available to the mainline media

>

> b: A statement from Med-El, including the link to the warning letter from the

FDA dated November

16,

> 2004

> http://www.fda.gov/foi/warning_letters/g5089d.htm

>

> May I suggest urgency in the implementation of the suggestions as delineated

afore.

>

> Deaf people are not fond of deceit...........

>

> Thank you.

>

> MacPherson

> Editor, Better Hearing News

> hohbob@...

> bhNEWS

>

>

>

>

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