FDA sues Advanced Bionics Cochlear Implant maker for 2.2 million in fines for manufac

rick48 said:
I did think you were referring to performance with the various brands. No, I have never experienced children getting into brand wars but have experienced parents doing so.

As for jill's continuing obsession to respond to my posts even though they have nothing to do with her, there is no need for you to bring them to my attention as its just further demonstrates the fact that anything she writes is of no importance or consequence to me.
Rick
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And yours would be of much more consequence to all if you could stick to the topic.
 
shel90 said:
This may be offtopic...

In the Deaf community, sometimes there is competition on who is Deaf enough, who is from Deaf families, and who is extremely fluent in ASL.

In the oral deaf community (with my best friend, a few others, and I), it was about who can understnad talking on the phone well enough, who has the better speech skills, and who is fully accepted by hearing peers.

Now, i am seeing that it may be a possiblity in the CI community..which CI brand is better.

Human nature is FUNNY!!!!! :laugh2:
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Interesting observations. I wonder if that is very common with oral deaf groups? I married quite young so I got out of the group scene quite early. Back when I hung out with my oral friends we didn't have cell phones then (they were around but not common) so there was no competition on that level. But I do remember among the guys it was who could drink the most and not get drunk. :roll:

Oh dear! Waaaay OT!
 
LadySekhmet said:
I dismissed Med El on three facts - One - Higher failure rates, Two - Ceramic housing - Uhh, if You ever fall on the implant it will crack, and BOOM, you have to have another surgery to replace it. Titanum is much stronger and durable. I believe Mel El NOW has titanum housing for all their implants. Three - it is ugly
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I recalled that my former client in PA had a surgery at a hospital in Hershey. She had her CI upgraded and asked me to provide her CI devices (such as batteries, FM system, etc). I warned her that it was a last time because she was given CI devices too many times in the past. Then, a few weeks later, her newly, upgraded CI was just died on her. Her third CI surgery was successful, but devices were not suitable to her another one CI. Yep, I was very pissed off because I shelled out over $3,000 to that devices that was not suitable to her 3rd CI replacement. That was OVR money. Gawd. :eek3:
 
R2D2 said:
Interesting observations. I wonder if that is very common with oral deaf groups? I married quite young so I got out of the group scene quite early. Back when I hung out with my oral friends we didn't have cell phones then (they were around but not common) so there was no competition on that level. But I do remember among the guys it was who could drink the most and not get drunk. :roll:

Oh dear! Waaaay OT!
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Well, in my experience with my oral deaf friends (was a VERY small group), we competed against each other about who can talk on the phone, who has the best speech, and who can assimilate with hearing people more. It is ridiculous but we got brainwashed into thinking the better speech/listening skills we had, the better off we were. Pretty sad for us to do that to each other. It was a waste of our time and did none of us good.
 
Boult said:
I wouldn't recommend reading news from other sites.. but FDA site

Here are the press release published by FDA themselves not by any news agency.

fine; FDA Seeks Civil Penalties from Calif. Device Maker

settlement; FDA Reaches Settlement with California Hearing Device Maker
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Can't get around the fact that AB has had fines of 1.1 million dollars levied against them for refusing to adhere to safety guidelines and putting patients at increased risk, nor that the CEO was assessed personally for fines totally 75,000.
 
One of the links I found EXPLAINS to why AB got the fine. Not some two bit filmsy press release vague statement . So, yes , I research to find the real reason why things happen or don't happen . Thanks to the education at Gallaudet I got in research.
smile.
 
CI in children

I understand the anxiety over the thought of a CI. However, it's a parent's choice of what to do with their child. You wouldn't want someone coming in and saying that you couldn't teach your child to sign because it would impair them in some way. I understand that this is major surgery and it's not exactly the same thing, but parents choose what they feel is best for their children. Not many parents (at least none I know) say to themselves, "what could I do to hurt my beautiful baby the most?" If they choose to have their child implanted, it's because they feel it is the best choice, and there are many children out there who have had great results with the device. Unfortunately, as with any surgery...there are those who have horrible, sometimes dangerous results. In the end though, it's the parents who have weighed out the risks and benefits and decided that this is the best option. They will be the one who has to deal with the outcome. I wish all parents out there who choose to have their child implanted to have the wonderful results they hope for. And remember, no matter the outcome God will always watch over us.

-Doc
 
docdoc said:
I understand the anxiety over the thought of a CI. However, it's a parent's choice of what to do with their child. You wouldn't want someone coming in and saying that you couldn't teach your child to sign because it would impair them in some way. I understand that this is major surgery and it's not exactly the same thing, but parents choose what they feel is best for their children. Not many parents (at least none I know) say to themselves, "what could I do to hurt my beautiful baby the most?" If they choose to have their child implanted, it's because they feel it is the best choice, and there are many children out there who have had great results with the device. Unfortunately, as with any surgery...there are those who have horrible, sometimes dangerous results. In the end though, it's the parents who have weighed out the risks and benefits and decided that this is the best option. They will be the one who has to deal with the outcome. I wish all parents out there who choose to have their child implanted to have the wonderful results they hope for. And remember, no matter the outcome God will always watch over us.

-Doc
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But,this thread is not about implanting children. It is about a CI maufacturer not adhering to manufacturing guidelines and, thus, putting CI some CI recipients at greater risk for serious complications.
 
docdoc said:
I understand the anxiety over the thought of a CI. However, it's a parent's choice of what to do with their child. You wouldn't want someone coming in and saying that you couldn't teach your child to sign because it would impair them in some way. I understand that this is major surgery and it's not exactly the same thing, but parents choose what they feel is best for their children. Not many parents (at least none I know) say to themselves, "what could I do to hurt my beautiful baby the most?" If they choose to have their child implanted, it's because they feel it is the best choice, and there are many children out there who have had great results with the device. Unfortunately, as with any surgery...there are those who have horrible, sometimes dangerous results. In the end though, it's the parents who have weighed out the risks and benefits and decided that this is the best option. They will be the one who has to deal with the outcome. I wish all parents out there who choose to have their child implanted to have the wonderful results they hope for. And remember, no matter the outcome God will always watch over us.

-Doc
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Nice post doc, seems like you understand what ci parents go through, welcome.

Are you the parent of a child with a ci?
Rick
 
jillio said:
But,this thread is not about implanting children. It is about a CI maufacturer not adhering to manufacturing guidelines and, thus, putting CI some CI recipients at greater risk for serious complications.
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Oops. Sorry, Jillio. I parroted you without reading this first.
 
LadySekhmet said:
I dismissed Med El on three facts - One - Higher failure rates, Two - Ceramic housing - Uhh, if You ever fall on the implant it will crack, and BOOM, you have to have another surgery to replace it. Titanum is much stronger and durable. I believe Mel El NOW has titanum housing for all their implants. Three - it is ugly

If you want to get into "which is better" then here's a fact - Freedom is better because you can use BOTH rechargable batteries AND 675s. Suppose you're stuck in the middle of nowhere, or on a camping trip..guess what, Just pack your regular 675 batteries (Although it is recommended to use the Powerful ones, I can still use the regular ones bought at the store) and you're good to go! I can go on and on...but I'm not.

All I am saying is knock it off. We all picked certain companies for different reasons. It's only going to get better. To me, there is NO reason why I need a "nifty remote" as I do not change the programs, only if I'm in a specific situation and that's pretty uncommon.

The only BIG plus I will say about Med El is they are MUCH better used for people/children who have ossification in their ears. Cochlear and AB is "long" due to a lot more electrodes. I have heard children and adults that use Med El for that specific reason, and it works well for them. Cochlear and AB (I believe), has a specific software to help that, but not hardware.


Basically what I'm trying to say is that to knock it off with "my brand is better". You like Med El, and if someone asked you for help with research, you will be the person I will tell them to go to. However, if they're swayed into it, then that's pressuring. I feel like I'm part of Console Wars all over again.
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I agree each company has different features. It was a shame that AB model had a defect in it. And they say they have now fixed. There was no physical harm to people who received the defected AB model, they just had the major issue of having to have surgery again to replace the internal parts. I personally picked Cochlear Americas model for my children because back when my son was being implanted the cochlear americas model was the only one FDA provided for children. And when my daughter was implant later on, I went with the company my son had because we had good results. My only issue with Med-El is that there are I think only a handful of implanted people with that model in my region and no audiologists who are able to program it.
 
jackiesolorzano said:
I agree each company has different features. It was a shame that AB model had a defect in it. And they say they have now fixed. There was no physical harm to people who received the defected AB model, they just had the major issue of having to have surgery again to replace the internal parts. I personally picked Cochlear Americas model for my children because back when my son was being implanted the cochlear americas model was the only one FDA provided for children. And when my daughter was implant later on, I went with the company my son had because we had good results. My only issue with Med-El is that there are I think only a handful of implanted people with that model in my region and no audiologists who are able to program it.
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My best friend contracted meningitis due to AB's model having a positioner at the time (2003). It trapped fluid and she got infected. It nearly killed her, so I digress when you say that people weren't harmed. People were. My friend was.
 
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