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

As usual. Boult gets a little " hot under the collar"... I would expect ANY CI company in the USofA ( or world ) to adhere to the highest standards of quality assurance. Especially since the device is implanted in someone's head for decades. Not to mention I gave AB every opportunity to explains themselves and even got kicked out of their forum room , Hearing Journey. Does that seem fair ? You tell me... I did my research and I waited till CI technology caught up to my comfort level and expectations. And I advise people to do their research and find out information as much as they possilble can about any device or services they use. I still am not comfortable with silicone in my body ( especially my head )so I chosed the ceramic internal device for safety and durablility and peace of mind. And yes the remote will come in handy in many many situations in everyday living. 3 AB users even told me they liked the remote they saw at the HLAA convention. (some Cochlear wearers even liked the remote feature too ) So, with that said BUYER BEWARE is always the best advice.
 
I don't think Boult got a little "hot under the collar." We wear Advanced Bionics and we know what is in our ears. The differences is I have faith in my company. I find that they do have a quality product. I know Boult has had his CI for quite awhile and I am bilateral for over a year.

Whatever brand you pick, only the person wearing them understands.

I almost picked Med El not because of anything but they were doing research and I would have had an opportunity to do the research. The device was not comfortable on my ears. I don't changed settings on my CIs throughout the day. I put them on 12 and put them on. The T-mic is great and that is all I need. Now Cochlear has nice small cochlear implants. I like the looks of them. In the end, I went with my instincts. I wanted the battery offered by AB.

By the way Hearing Journey is a great resource. If you had questions with the product go to the company not the users. We know what it is like to wear these, but we don't know everything about the company. As we shouldn't know, we don't run the company.
 
R2D2 said:
Med El is not a big player in the US, which is the biggest market in the world for CIs. For a while, I believe they had problems getting FDA approval, I'm not sure of the reason why but anyway that affected their ability to establish there for a while. Their market share is now slowly growing I believe.

Business is business and I'm not convinced that if Med El had a much bigger market share, they wouldn't operate too differently to AB, Cochlear or any of the large hearing aid manufacturers. I'm not excusing the past behaviour but just stating the cynical reality of for profit business in your country. In Europe where Med El has it's biggest market share, socialised medicine is the norm and such markets tend to be well regulated.

Southfella has the right to post his mine-is-more-advanced posts if he wants to but it isn't the culture that we have on this board and it is over the top. We just want every user to be happy, whatever CI choice they make.
Deafdyke often makes the point that she feels some CI users are "gotta have the latest gadget" types. Southfella seems to come close from my perspective.
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I don't think they are a big player in the US because of the design. My first thought was it doesn't look like a hearing aid. It also felt uncomfortable. After wearing HA for 27 years, I could not make that change to the design. My ears had a hard time handling the change from hearing aids to cis as it was. My audie said Med-El was changing there design.
 
SouthFella said:
As usual. Boult gets a little " hot under the collar"... I would expect ANY CI company in the USofA ( or world ) to adhere to the highest standards of quality assurance. Especially since the device is implanted in someone's head for decades. Not to mention I gave AB every opportunity to explains themselves and even got kicked out of their forum room , Hearing Journey. Does that seem fair ? You tell me... I did my research and I waited till CI technology caught up to my comfort level and expectations. And I advise people to do their research and find out information as much as they possilble can about any device or services they use. I still am not comfortable with silicone in my body ( especially my head )so I chosed the ceramic internal device for safety and durablility and peace of mind. And yes the remote will come in handy in many many situations in everyday living. 3 AB users even told me they liked the remote they saw at the HLAA convention. (some Cochlear wearers even liked the remote feature too ) So, with that said BUYER BEWARE is always the best advice.
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:gpost::gpost:
 
vallee said:
I don't think Boult got a little "hot under the collar." We wear Advanced Bionics and we know what is in our ears. The differences is I have faith in my company. I find that they do have a quality product. I know Boult has had his CI for quite awhile and I am bilateral for over a year.

Whatever brand you pick, only the person wearing them understands.

I almost picked Med El not because of anything but they were doing research and I would have had an opportunity to do the research. The device was not comfortable on my ears. I don't changed settings on my CIs throughout the day. I put them on 12 and put them on. The T-mic is great and that is all I need. Now Cochlear has nice small cochlear implants. I like the looks of them. In the end, I went with my instincts. I wanted the battery offered by AB.

By the way Hearing Journey is a great resource. If you had questions with the product go to the company not the users. We know what it is like to wear these, but we don't know everything about the company. As we shouldn't know, we don't run the company.
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The whole point of the lawsuit against AB was that people thought they knew what was implanted into their bodies, but quite obviously they didn't know. Defective parts that were the direct result of AB's financial concerns were implanted into individuals and put them at greater risk for complication and additional surgery. They did not know that they had been implanted with parts that were outsourced to a cheaper manufacturer, and were led to believe that AB was following the standards as set forth by the FDA.
 
jillio said:
Yep, that cost effectiveness to society argument always makes me want to scream! Where the hell are our priorties?
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But is it REALLY cost affective. I only see evidence to the contrary. I would have thought a full tool box aproach would be much more cost affective. Plus more in depth assessments to make sure that all those kids really WANT them and of course they would have to be old enough to express that view. Preferably using sign language. Some people with CI only hear environmental noises but their have been other systems on the market that can also give people awareness of environmental noises such as the tactiaid but unfortunately they are now out of buisness because CI's get funded by state and other cheaper alternatives such as hearing aids and tactile aids don't. Exactly how cost effective is that?
 
dreama said:
But is it REALLY cost affective. I only see evidence to the contrary. I would have thought a full tool box aproach would be much more cost affective. Plus more in depth assessments to make sure that all those kids really WANT them and of course they would have to be old enough to express that view. Preferably using sign language. Some people with CI only hear environmental noises but their have been other systems on the market that can also give people awareness of environmental noises such as the tactiaid but unfortunately they are now out of buisness because CI's get funded by state and other cheaper alternatives such as hearing aids and tactile aids don't. Exactly how cost effective is that?
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Exactly, dreama! It is not cost effective in any capacity. That's why it always makes me want to scream when someone pulls that argument out of their hat.
 
Gigabyte said:
Excuse Me, but I have to disagree, many people have died because of deafness, or have you forgotten about the tragic death of Miss Teen Texas a few years ago, she was struck and killed by a train because she was Deaf and could not hear the train or the warning whistle! I do not have statistics, but every year there are several reports of deaf persons dieing (or being seriously injured) because they were not alerted to danger around them such as fire alarms, oncoming cars etc, so don't say deafness can't be fatal, it can easily be the major factor in death or serious injury.
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First of all people with CI's are deaf too. This is something that seems to be overlooked rather a lot. Particularly by people outside deaf world.

Imagine sinario. Deaf person known to have CI is walking into a pertentially dangerous situation. Someone calls out to warn them. Deaf person doesn't respond because batteries are flat. So Deaf person doesn't know about the danger and gets killed just because someone assumed they could hear. If it had been a signing deaf person then they would have made more effort to make sure that person was aware by manual means not just by calling out. This is just an imaginery sinario. I wander if anything like this has happened. I'd be curious to know.
 
faire_jour said:
I think the whole key to the issue is that all of you CHOOSE to have an implant. You made an informed decision for yourself. Maybe you had side-effects, maybe you didn't, but it was your choice. People are implanting thosands of young children, as young as 6 months old, who have no input and are not involved in the process at all.
You want a CI, do your research and decide as an adult if you want to take the leap....my concern is the children who haven't chosen this for themselves.
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Good point.
 
dreama said:
First of all people with CI's are deaf too. This is something that seems to be overlooked rather a lot. Particularly by people outside deaf world.

Imagine sinario. Deaf person known to have CI is walking into a pertentially dangerous situation. Someone calls out to warn them. Deaf person doesn't respond because batteries are flat. So Deaf person doesn't know about the danger and gets killed just because someone assumed they could hear. If it had been a signing deaf person then they would have made more effort to make sure that person was aware by manual means not just by calling out. This is just an imaginery sinario. I wander if anything like this has happened. I'd be curious to know.
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I have been deaf the majority of my life and all I can say to this is WTF! That is not my world, sorry.
 
dreama said:
First of all people with CI's are deaf too. This is something that seems to be overlooked rather a lot. Particularly by people outside deaf world.

Imagine sinario. Deaf person known to have CI is walking into a pertentially dangerous situation. Someone calls out to warn them. Deaf person doesn't respond because batteries are flat. So Deaf person doesn't know about the danger and gets killed just because someone assumed they could hear. If it had been a signing deaf person then they would have made more effort to make sure that person was aware by manual means not just by calling out. This is just an imaginery sinario. I wander if anything like this has happened. I'd be curious to know.
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How would someone be able to tell a signing deaf person visually? When not signing, they look exactly like hearing people. At least with a device on our ears, we look deaf on the outside. I've noticed sometimes that people change their behaviour when they see a HA or CI. For example making sure they face me and speak clearly.

Your post has actually highlighted an advantage of wearing a device!
 
vallee said:
From Ear Hear April 2007 A multicenter study of device failure in European ...[Ear Hear. 2007] - PubMed Result

of 1987 Med El devices (Med-El, Innsbruck, Austria), 179 had failed;

All Cochlear implants have system failures. Of 8,581 Nucleus devices (Cochlear, Sydney, Australia), 169 had failed; of 1,761 Advanced Bionics systems (Advanced Bionics, Sylmar, USA), 123 had failed.
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I think this goes to show that the my-brand-is-better-than-yours rhetoric is pointless. For the person whose device has failed, no matter what brand it is, the design, whether or not it has a remote, whether it makes you look like Dumbo just goes out the window on the scale of importance.
 
R2D2 said:
I think this goes to show that the my-brand-is-better-than-yours rhetoric is pointless. For the person whose device has failed, no matter what brand it is, the design, whether or not it has a remote, whether it makes you look like Dumbo just goes out the window on the scale of importance.
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bingo
 
vallee said:
From Ear Hear April 2007 A multicenter study of device failure in European ...[Ear Hear. 2007] - PubMed Result

of 1987 Med El devices (Med-El, Innsbruck, Austria), 179 had failed;

All Cochlear implants have system failures. Of 8,581 Nucleus devices (Cochlear, Sydney, Australia), 169 had failed; of 1,761 Advanced Bionics systems (Advanced Bionics, Sylmar, USA), 123 had failed.
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System failures and outsourcing of manufactured parts that do not meet with FDA standards are 2 spearate issues. AB was sued because they knew they were outsoucing to a substandard manufacturer and knowingly put people at risk. That is why the CEO is personally responsible for a large dollar amount of the settlement.
 
jillio said:
System failures and outsourcing of manufactured parts that do not meet with FDA standards are 2 spearate issues. AB was sued because they knew they were outsoucing to a substandard manufacturer and knowingly put people at risk. That is why the CEO is personally responsible for a large dollar amount of the settlement.
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misleading facts...
 
jillio said:
System failures and outsourcing of manufactured parts that do not meet with FDA standards are 2 spearate issues. AB was sued because they knew they were outsoucing to a substandard manufacturer and knowingly put people at risk. That is why the CEO is personally responsible for a large dollar amount of the settlement.
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Show me where it states the product is outsourced?

We don't know why the CEO paid the fine.
 
vallee said:
Show me where it states the product is outsourced?

We don't know why the CEO paid the fine.
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Click on the link. Clearly states, "AB failed to notify the FDA of a new vendor that supplied the component", and also that this is not the first time that AB has been in violation of manufacutring standards. In addition, it states that a previous recall by AB of CIs was traced to components supplied by this unapproved vendor.

Yes, we do know. The CEO was levied with the fine because the FDA had evidence that he knowingly failed to comply with the FDA standards for safety.
 
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