Cochlear Americas Receives FDA Warning Letter

why so many blanks?

eventhough, i don't clearly understand whats going on.. is there something i have to worry about?
(i hate all the legal words and terms they're so confusing)
 
Nothing to worry about but what they did is unethically and morally wrong in Clinical study. FDA is warning them to stop doing practice and follow the FDA guild lines.
 
It looks as if they were a bit sloppy with the procedure for consent paperwork in trials and in communication between centers during trials for a product that isn't currently on the market.

There is no problem in the FDA warning with any of their CIs or with the manufacturing process. :)
 
Don't laugh! I've been wondering how scientist and researchers have discovered the CI on what animals? I mean, research on rats or monkeys? I would think HOH monkeys before I could think of a rat having a hearing test. :) Suzi
 
Fuck to FDA, it does happen on vitamin, mineral and whatever then trying screw us up.

I don't trust in FDA, they make stupid thing to do like warning or ban on stuff, not means for CI.

Our FREEDOM is allowing to get CI in anytime, if you want too... :)
 
Like others were saying it was for a investigative product in early stage of trials not in production.

orysia60 said:
I read the letters, I guess that nothing is wrong so Iam CI that since 2003 My Ci is well and to hear good. It gives me to worry about it but I must to be good faith that way. If it is serious to please let me know soon.
thnk
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The aussie members of AD have it right. Good Work and G'DAY!

I work in an environmetal Lab and we have inspections every so often as well. In our case the Department of Health Services does the inspection. If the inspector finds anything wrong it is discussed at the time of the inspection and then the inspector sends a deficiency letter aftewards. The deficiency letter spells out exactly what has to be done and when the corrections have to be made. Like the FDA letter that was posted the inspector refers to a specific CFR -Code of Federal regulations in the letter.
It is up to the organization to prove to the inspector that corrections have been made. I just sent a 1.5 pounds of paper to an inspector so our lab can be certified for a new procedure. I would hate to think what cochlear would need to do. Documentation is a big thing with these inspectors and that seems to be the main deficiency in cochlear's case.

If you need help sleeping or want to find out more you can do a search for the code of federal regulations. I just thought I would give by .02c
 
There you have it folks. You can go back to whatever it was you were doing and stop worrying about it. I'm sure this keep some people awake at night...:whistle:
 
This is exactly what I have been posting about. Another case of research not being valid or reliable. Data that is obtained under questionable methodology is nothing but trash.

Unfortunately, the manufacturers responsible for making this trash available to the general public function under the assumtion that the majority of those seeking information and trying to make decisions regarding the feasibility do not have the background that will allow them to read a research report and find all of the inconsistencies and errors that would invalidate it. They therefore, are preying on the public. I find this to be reprehensible, and no matter how many times I am incorrectly labeled anti-CI and extremeist for my efforts, I will continue to speak out.
 
jillio said:
This is exactly what I have been posting about. Another case of research not being valid or reliable. Data that is obtained under questionable methodology is nothing but trash.

Unfortunately, the manufacturers responsible for making this trash available to the general public function under the assumtion that the majority of those seeking information and trying to make decisions regarding the feasibility do not have the background that will allow them to read a research report and find all of the inconsistencies and errors that would invalidate it. They therefore, are preying on the public. I find this to be reprehensible, and no matter how many times I am incorrectly labeled anti-CI and extremeist for my efforts, I will continue to speak out.
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Sorry, but it's premature to spout your view not actually knowing anything about the facts and details of what has happened and to what extent it affects consumers across the board. It would be much more sensible to get more information on it to determine whether or not it's a big issue before passing your judgement.

So you are going to "speak out" but claim you aren't anti CI. Sorry, but you don't come across as someone who just has a moderate interest in a deaf issue, you come across as someone who has strong feelings about CIs and your level of participation in this forum indicates this.
 
R2D2 said:
Sorry, but it's premature to spout your view not actually knowing anything about the facts and details of what has happened and to what extent it affects consumers across the board. It would be much more sensible to get more information on it to determine whether or not it's a big issue before passing your judgement.

So you are going to "speak out" but claim you aren't anti CI. Sorry, but you don't come across as someone who just has a moderate interest in a deaf issue, you come across as someone who has strong feelings about CIs and your level of participation in this forum indicates this.
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I dont think Jillo was talking about the CIs themselves..just talking about research in general. Like how some research becomes invalid due to inconsistencies.
 
shel90 said:
I dont think Jillo was talking about the CIs themselves..just talking about research in general. Like how some research becomes invalid due to inconsistencies.
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Sorry but I concur with R2D2.

and this warning letter is not about researches, it is about doing the clinic study procedures ( clinic study = clinical trial ) the proper way. all CI makers do Clinical Trials to gathers facts and etc before presenting to FDA for approval to be put on market. ...nothing about researches.

What Cochlear Americas in Denver failed to do is follow FDA guidelines for clinic study. So FDA ask C.A. to correct their procedures and present documents before they can move to approval stages.
 
Boult said:
Sorry but I concur with R2D2.

and this warning letter is not about researches, it is about doing the clinic study procedures ( clinic study = clinical trial ) the proper way. all CI makers do Clinical Trials to gathers facts and etc before presenting to FDA for approval to be put on market. ...nothing about researches.

What Cochlear Americas in Denver failed to do is follow FDA guidelines for clinic study. So FDA ask C.A. to correct their procedures and present documents before they can move to approval stages.[/QU


I didnt see any mention of CI in Jillo's statement. Is she talking about CIs specificially or just general research or clinical studies?
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:confused:

Why they use real name "Chris Smith" and "Timothy A. UIatowak" to the internet? Due the respect, their name should be removal or add black color to cover their real names before open warning letter to the internet. ?
 
R2D2 said:
Sorry, but it's premature to spout your view not actually knowing anything about the facts and details of what has happened and to what extent it affects consumers across the board. It would be much more sensible to get more information on it to determine whether or not it's a big issue before passing your judgement.

So you are going to "speak out" but claim you aren't anti CI. Sorry, but you don't come across as someone who just has a moderate interest in a deaf issue, you come across as someone who has strong feelings about CIs and your level of participation in this forum indicates this.
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I have strong feeling against the manipulation of statistics and experimental data that is provided to the public as accurate information. Ihae a particular problem with it when it is done intentionally , and the effect is to increase profit without concern for those who may be adversely affected when making decisions on intentionally innacurrate iformation. That does not make me anti CI.
 
shel90 said:
Boult said:
Sorry but I concur with R2D2.

and this warning letter is not about researches, it is about doing the clinic study procedures ( clinic study = clinical trial ) the proper way. all CI makers do Clinical Trials to gathers facts and etc before presenting to FDA for approval to be put on market. ...nothing about researches.

What Cochlear Americas in Denver failed to do is follow FDA guidelines for clinic study. So FDA ask C.A. to correct their procedures and present documents before they can move to approval stages.[/QU


I didnt see any mention of CI in Jillo's statement. Is she talking about CIs specificially or just general research or clinical studies?
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Clinical study and clinical trial fall into the category of research. Maybe I should have been more specific. The information that is obtained and analyzed through the use of statistical procedures determines whether a surgical procedure or a particular product is offered on the market. If clinical guidelines are not followed, inaccurate information is being released to the public.
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jillio said:
I have strong feeling against the manipulation of statistics and experimental data that is provided to the public as accurate information. Ihae a particular problem with it when it is done intentionally , and the effect is to increase profit without concern for those who may be adversely affected when making decisions on intentionally innacurrate iformation. That does not make me anti CI.
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I would have strong feelings about that too. But where is your information that manipulation of statistics occurred?
 
R2D2 said:
I would have strong feelings about that too. But where is your information that manipulation of statistics occurred?
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Not following clinical guidelines pretty much guarantees that staistics are being manipulated. If you skew your population sample, etc. intentionally to produce the results you desire you are manipulating statisticsal results.
 
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