While I support
Cochlear because it's the manufacturer of my CIs, I still reach out for the others such as
Advance Bionics and Med-El because to me, it doesn't really matter what brand a CI person has, but the process on how they use their CI matters to me.
I have read on stuff about Advance Bionics and their HiRes 90K implant and how there has been a recall. The way I read it was HiRes90K was pulled off the market by Advance Bionics voluntarily. This is due to the fact of the positioners that was used at that time, and it seemed to cause issues with implant failures and increased risk of meningitis in children. Since the increase of meningitis has appeared, it has been required for all CI surgery patients to get vaccinated for it. The implant failures has to do with moisture getting in there. The big issue was that Advance Bionics never informed FDA that they used another company's product to include with their implant.
Boult from AllDeaf.com says it well in 2006 - " Since AB has more than one vendors that supplies parts to AB to assembly the implant.
So in the last recall, it is like this Vendor A = 99% free of defect. Vendor B = 97% free of defect So First step AB do is recall all UNimplanted Vendor B to be taken back to AB and replace them with Vendor A. Then AB end contract with Vendor B supplier and switch to other Vendor. Then AB notify all AB users with Vendor B that they are on recall list and suggest them to visit their CI center to determine whether or not they can continue to use it as a "400 Days Test" If their CI pass "400 days test" then they are not defective. If one's device fails within "400 days test" then they will get theirs replaced with new one at AB's expense."
It has been an issue with some AB users that suffered the recalls (in fact, a few of them were reimplanted and was happy regardless), and has been used as a scapegoat by the deaf community of why deaf people should not be implanted.
SO....some people STILL bring up about AB's recall, and says this is the reason why they won't go with this company. I find that preposterous. Although, AB got fined by FDA.
Anyways..there's a class-action
lawsuit going around against Advance Bionics. The website is basically having AB users that had issues with their implant to come forward.
Everyone signed a paper that you accepted all risks with surgery. I do love this statement though: "
According to the FDA, certain Advanced Bionics HiRes90K cochlear implants may 'pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.' "
Potential for additional hearing loss - what?! All I can is..DUH? I think almost every single CI user could care less that they lost what they had. I don't care that if I lost my residual hearing.
I had to edit this post, I typed a little too fast and didn't quite get my facts straight, hope it's straight now. This is what I get for typing right before bed. Basically my point is I'm just laughing about the statement that was stated on the website. I could care less about the lawsuit.
Here's another website that I had to chuckle at: Reuters's article in March 2008. Take a look at this statement and tell me what's wrong? " On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a hearing aid surgically implanted under the skin behind the ear, to treat profound hearing loss in adults and children."
"Implantable Cochlear Stimulator"? What? :-)
"A hearing aid..." It's a Implantable Cochlear stimulator! It's a Hearing Aid! It's SUPERMAN! Oh give me a break. It's a cochlear implant.
I have read on stuff about Advance Bionics and their HiRes 90K implant and how there has been a recall. The way I read it was HiRes90K was pulled off the market by Advance Bionics voluntarily. This is due to the fact of the positioners that was used at that time, and it seemed to cause issues with implant failures and increased risk of meningitis in children. Since the increase of meningitis has appeared, it has been required for all CI surgery patients to get vaccinated for it. The implant failures has to do with moisture getting in there. The big issue was that Advance Bionics never informed FDA that they used another company's product to include with their implant.
Boult from AllDeaf.com says it well in 2006 - " Since AB has more than one vendors that supplies parts to AB to assembly the implant.
So in the last recall, it is like this Vendor A = 99% free of defect. Vendor B = 97% free of defect So First step AB do is recall all UNimplanted Vendor B to be taken back to AB and replace them with Vendor A. Then AB end contract with Vendor B supplier and switch to other Vendor. Then AB notify all AB users with Vendor B that they are on recall list and suggest them to visit their CI center to determine whether or not they can continue to use it as a "400 Days Test" If their CI pass "400 days test" then they are not defective. If one's device fails within "400 days test" then they will get theirs replaced with new one at AB's expense."
It has been an issue with some AB users that suffered the recalls (in fact, a few of them were reimplanted and was happy regardless), and has been used as a scapegoat by the deaf community of why deaf people should not be implanted.
SO....some people STILL bring up about AB's recall, and says this is the reason why they won't go with this company. I find that preposterous. Although, AB got fined by FDA.
Anyways..there's a class-action lawsuit going around against Advance Bionics. The website is basically having AB users that had issues with their implant to come forward.
Everyone signed a paper that you accepted all risks with surgery. I do love this statement though: " According to the FDA, certain Advanced Bionics HiRes90K cochlear implants may 'pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.' "
Potential for additional hearing loss - what?! All I can is..DUH? I think almost every single CI user could care less that they lost what they had. I don't care that if I lost my residual hearing.
I had to edit this post, I typed a little too fast and didn't quite get my facts straight, hope it's straight now. This is what I get for typing right before bed. Basically my point is I'm just laughing about the statement that was stated on the website. I could care less about the lawsuit.
Here's another website that I had to chuckle at: Reuters's article in March 2008. Take a look at this statement and tell me what's wrong? " On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a hearing aid surgically implanted under the skin behind the ear, to treat profound hearing loss in adults and children."
"Implantable Cochlear Stimulator"? What? :-)
"A hearing aid..." It's a Implantable Cochlear stimulator! It's a Hearing Aid! It's SUPERMAN! Oh give me a break. It's a cochlear implant.