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
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.
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.
Sorry but I concur with R2D2.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.
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?
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.
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?
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.
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.
I would have strong feelings about that too. But where is your information that manipulation of statistics occurred?