Cochlear Implant Surgery: Risks and stuff...

Phi4Sius · 02-17-2009, 12:42 AM

Okay. We all know of the success stories of Cochlear Implants - the okay, good, and awesome ones. However, my latest questions concern the following: what are the risks involved with Cochlear Implant Surgery? What are the failure rates between the top two companies: Advanced Bionics and Cochlear? While I'm aware that there are failure rates involved with those that have no desire to go through the subsequent mappings involved, the lack of patience to deal with the device, and other factors, what are the true failure rates of the equipment? How often have the internal components failed and you've had to have surgery to get new internal components? How often have the internal components failed to deliver the appropriate sound to those that have had profound loss in one ear and good hearing in one ear for 20+ years? Has the equipment ever failed to provide satisfactory hearing in spite of the individual's willingness and motivation to go through every step involved in attaining close-to-normal hearing (surgery/implantation, mappings, rehab, speech therapy, etc.)?

As a potential CI user, I want to investigate all possible benefits and the good results, as well as the ones that have failed. I want to have realistic expectations going into this whole thing.

Hear Again · 02-17-2009, 01:02 AM

It's impossible to compare the failure rates between Cochlear and Advanced Bionics since they use two different ways of reporting implant failures. I can't explain what they are; all I know is that they are different. If by chance you experience an implant failure, you can be re-implanted. Having said that, I think all CIs (at least those from Cochlear) have a warranty of 10 years. As for the risks of CI surgery, they are no different than any other: adverse reactions to anethesia, dizziness, nausea, numbness near implant site and/or tongue, taste disturbance that may be temporary or permanent, headaches and tinnitus. I would talk to your CI surgeon further if you are deemed a candidate for more specific details as to what you can expect from surgery.

ncff07 · 02-17-2009, 01:22 AM

Quote:

Originally Posted by Hear Again

It's impossible to compare the failure rates between Cochlear and Advanced Bionics since they use two different ways of reporting implant failures. I can't explain what they are; all I know is that they are different. If by chance you experience an implant failure, you can be re-implanted. Having said that, I think all CIs (at least those from Cochlear) have a warranty of 10 years. As for the risks of CI surgery, they are no different than any other: adverse reactions to anethesia, dizziness, nausea, numbness near implant site and/or tongue, taste disturbance that may be temporary or permanent, headaches and tinnitus. I would talk to your CI surgeon further if you are deemed a candidate for more specific details as to what you can expect from surgery.

the implanted part has a 10 year warrenty. the external parts, have a 3 year warrenty. ill see if i can scan my warrenty sheet somewhere and post if wanted. my audiologist came in during my surgery and tested the implant itself to make sure it worked 100% before closing up so that reduces the chance of a failure to pretty much zero. not sure if all hospitals test like that or not though. and like hear again said it would be a good idea to talk to someone about it to find out if your even a candidate for getting one. the criteria here was pretty strict in order to be a candidate. no sense in wasting alot of time researching everything just to find out you cant do it.

overthepond · 02-17-2009, 01:40 AM

Pretty much same answer as Hear again and ncff07,

Both companies (and medel) proved to be great as each other, you cannot be sure about reliablity as they are competing each other so we will never really know the full truth. We are aware that AB had implant recall few years ago but i am sure they learnt their lesson and would be ok. They all have well over 90 % reliablity.

ncff07, I had the test (nerve response test = NRT) while under GA, I am sure all hospitals does this other wise it would be very expensive to re implant if it doesn't work at switch on.

In britian it's standard to stay overnight and x-rayed in the morning before going home with bag of pills (anti inflam, anti bios, painkillers)

I think Hear Again or was it someone else did a pre and post CI list and it was very good... it's here somewhere...

Phi4Sius · 02-17-2009, 01:48 AM

overthepond - My audiologist was talking about a test that they use to evaluate the hearing nerve with electrodes before considering you to be a candidate for a Cochlear Implant. Is this what you're referring to? Or is that a different part of the process?

I was under the impression that testing the hearing nerve with electrodes was a fairly straightforward procedure that didn't require general anesthesia. They just place electrodes next to your ear drum, neck, and back of the head to measure the electrical response/viability of the nerve for the potential success of the implant.

I could be wrong...

overthepond · 02-17-2009, 02:02 AM

http://www.alldeaf.com/hearing-aids-...gery-tips.html

found it!

OP, No, the one you described is called ABR (Auditory Brain response) (completely painless and you would need to be very quiet. As for NRT you need Coil and Implant.

NRT is quite unpleasant as it tests higher than your threshold at switch on hence it's best to be done under GA and also to test if the Implant is working correctly. I had another one a month ago, it wasn't too bad as my thresholds are within my max nerve response levels.

Hear Again · 02-17-2009, 04:25 AM

Phi,

When I was evaluated for my CIs (both times) I was given an ABR. The test was quite simple. All it involved was placing electrodes on my forehead, leaning back in a comfortable leather chair and relaxing quietly while the ABR machine did all the work. It was completely painless.

Hear Again · 02-17-2009, 04:32 AM

I was referring to the internal implant -- not the external processor. Sorry for the confusion. Most hospitals test a CI to make sure it is functioning during surgery before suturing. I know my hospital did although my CI audis (I had one audi for my first CI and another for my second whom I'm still working with) were not the ones who tested my CIs. They were 2 different audis I've never met before.

LadySekhmet · 02-17-2009, 09:50 AM

Quote:

Originally Posted by ncff07

the implanted part has a 10 year warrenty. the external parts, have a 3 year warrenty. ill see if i can scan my warrenty sheet somewhere and post if wanted. my audiologist came in during my surgery and tested the implant itself to make sure it worked 100% before closing up so that reduces the chance of a failure to pretty much zero. not sure if all hospitals test like that or not though. and like hear again said it would be a good idea to talk to someone about it to find out if your even a candidate for getting one. the criteria here was pretty strict in order to be a candidate. no sense in wasting alot of time researching everything just to find out you cant do it.

Yeah - not every hospital does that. I think centers or ORs that is used specifically for CI implantation have the ability to test out the implant to full extent. I went to a regular hospital where my surgeon just sets up the OR. I had the NRT done later. I think they tested the electrodes in the OR, but not the NRT.

In my left, one electrode was not functioning (which is okay, it sometimes happens), and two was not functioning in my right. Oddly, when I went for my mapping and NRT in Vegas (since the OR is not CI specific, no NRT was done, but I have no idea why my first audiologist didn't do NRT when I was activated), now all of the 3 "non-functioning" ones are working...they were stubborn.

As for Failure rates - most of the time that is shown "failure" rates is more of surgeon's fault...either it wasn't implanted deep enough, or got twisted, etc. So, it would not function properly. I think there's a very very low number of actual mechanical failures for the implants (both AB and Cochlear. Med-El has a more mechanical failures, but still a low number). Hence why the implants are tested before closing up...if it doesn't work, then they just stick in a new one without trying to go through the trouble of why it won't work.

The AB failures a while back had to do with the positioners. It has been long resolved by now, but unfortunately, they got a bit of a bad rap.

IF, for whatever reason, my implants failed - I would opt for another surgery. I don't care...2 weeks of being laid up is just a small inconvenience compared for having much better hearing.

Processor failures is not a big deal...they're easily replaceable, fixable, etc.

Byrdie714 · 02-17-2009, 09:57 AM

FDA Warns about CI has it can cause menigitis:

Quote:

The Food and Drug Administration (FDA) has become aware of a possible association between cochlear implants and the occurrence of bacterial meningitis. Worldwide, we know of 91 reports of meningitis in patients implanted with the three FDA-approved cochlear implant devices: Advanced Bionics Corporation devices (56 cases), Cochlear Limited devices (33 cases) and MED-EL Corporation devices (1 case). A total of 17 deaths have resulted from these meningitis cases.

Link: Medical Device Safety: Advice for Patients with Cochlear Implants: New Information on Meningitis Risk

Medical News today: Cochlear Implantation Increases Meningitis Risk

We also had a debate about this: http://www.alldeaf.com/hearing-aids-...-implants.html

Hope this helps Phi4Sius.

LadySekhmet · 02-17-2009, 10:09 AM

Good links byrdie714.

I just want to point out again, that the implant THEMSELVES do not cause meningitis. It's the surgery. If doctors do not prep the incision properly, or neglect to obey the laws of the OR (keeping every damn thing around the surgical site sterile...which sometimes is an tough task!), etc. The only way that bacteria can get inside the site is if something else that is not considered sterile.

I've seen dogs and cats get bad infections from a SIMPLE spay/neuter surgeries. While they have survived with better cleansing, infections still happens.

However, now with Vaccination requirements, the risk is very small.
Correct me if I'm wrong - I think if children were implanted, they're more at risk than adults due to immune system.

Byrdie714 · 02-17-2009, 10:22 AM

Quote:

Originally Posted by LadySekhmet

Good links byrdie714.

I just want to point out again, that the implant THEMSELVES do not cause meningitis. It's the surgery. If doctors do not prep the incision properly, or neglect to obey the laws of the OR (keeping every damn thing around the surgical site sterile...which sometimes is an tough task!), etc. The only way that bacteria can get inside the site is if something else that is not considered sterile.

I've seen dogs and cats get bad infections from a SIMPLE spay/neuter surgeries. While they have survived with better cleansing, infections still happens.

However, now with Vaccination requirements, the risk is very small.
Correct me if I'm wrong - I think if children were implanted, they're more at risk than adults due to immune system.

Not a problem Lady....

However the doctor has to make sure that you are vaccinated and if not and he/she implants you with the CI--you are running a risk of meningitis as CI, plus non-vaccination can start this.....

If the doctor doesn't check-up on your vaccination--then you don't want that doctor.

As for adults--they can also contract meningitis due to a compromise immune system.

etalton · 02-17-2009, 11:16 AM

Quote:

Originally Posted by Byrdie714

Not a problem Lady....

However the doctor has to make sure that you are vaccinated and if not and he/she implants you with the CI--you are running a risk of meningitis as CI, plus non-vaccination can start this.....

If the doctor doesn't check-up on your vaccination--then you don't want that doctor.

As for adults--they can also contract meningitis due to a compromise immune system.

I agree on that. I had to fax my shot record to my surgeon's office before they would go ahead with plans for my surgery.

etalton · 02-17-2009, 11:19 AM

I don't know about AB, but Cochlear claims they have a 1% failure rate on their implants from what I read. Not bad odds.

faire_jour · 02-17-2009, 11:50 AM

AB calls every implant removed a failure, Cochlear only calls the ones they find a mechanical problem with a failure.

That being said, I only know about the rates for children. 1 in 10 children will need to go back in for another surgery. The rate for adults is lower. This includes ANY kind of revision surgery.

The highest complication is not menengitis, but skin flap issues. My daughter's ENT and audiologist say that it is a very serious complication, and the most common. So, DON'T WEAR YOUR MAGNET TOO TIGHT!!!

overthepond · 02-17-2009, 12:15 PM

Faire jour is right about having magnet on too "tight", magnet being too tight would restrict blood circulation surrounding the area of the skin over the implant. U can tell as it would ache, bit like sitting on one leg too long.

I find my magnet a bit loose probably due to my hair is getting longer and thicker, it had been 7 months since my operation and i had massive area shaven off!!!! I have a spare magnet of extra strength now so i can use it while i am sailing/riding horses/skiing for extra security but i always change them back straight away.

ncff07 · 02-17-2009, 12:20 PM

i was told by the surgeon the muscle/tissue on my head is rather thick and when i emailed my audiologist about this she said she knew the surgeon had recommended a strong magnet and that she had already ordered 2 of the strongest ones since they dont normally keep those in stock.

i could have told them that before the surgery, ive always been hard headed!

deafaussie · 02-17-2009, 12:27 PM

My right ear was implanted with Cochlear CI24 Contour 10 years ago and was told by my surgeon prior to surgery. Prior to closing skin incision, test equipment 'tests' the internal device to ensure it is functioning according to the manufacturer's specifications.

Two years ago, I had a tour in Cochlear manufacturing facility in Sydney, Australia and I was surprised that these internal implants are over engineered, designed and built to withstand 75 year lifespan under normal conditions.

Ask your surgeon about the test.

overthepond · 02-17-2009, 12:31 PM

Quote:

Originally Posted by deafaussie

Two years ago, I had a tour in Cochlear manufacturing facility in Sydney, Australia and I was surprised that these internal implants are over engineered, designed and built to withstand 75 year lifespan under normal conditions.

Ask your surgeon about the test.

That's great to hear, i won't have to worry about it conking out before my time!! (pray for no failures!)

Hear Again · 02-17-2009, 06:23 PM

I went from having a #2 magnet down to #1 due to illness and having lost weight. I now weigh 114 pounds, but can waver between 109 and 120. As a result, I end up changing my magnet several times a year.

02-17-2009, 12:42 AM	#1 (permalink)
Phi4Sius Technology Buff Join Date: Jan 2009 Posts: 408	Cochlear Implant Surgery: Risks and stuff... Okay. We all know of the success stories of Cochlear Implants - the okay, good, and awesome ones. However, my latest questions concern the following: what are the risks involved with Cochlear Implant Surgery? What are the failure rates between the top two companies: Advanced Bionics and Cochlear? While I'm aware that there are failure rates involved with those that have no desire to go through the subsequent mappings involved, the lack of patience to deal with the device, and other factors, what are the true failure rates of the equipment? How often have the internal components failed and you've had to have surgery to get new internal components? How often have the internal components failed to deliver the appropriate sound to those that have had profound loss in one ear and good hearing in one ear for 20+ years? Has the equipment ever failed to provide satisfactory hearing in spite of the individual's willingness and motivation to go through every step involved in attaining close-to-normal hearing (surgery/implantation, mappings, rehab, speech therapy, etc.)? As a potential CI user, I want to investigate all possible benefits and the good results, as well as the ones that have failed. I want to have realistic expectations going into this whole thing.

02-17-2009, 10:09 AM	#11 (permalink)
LadySekhmet Cyborg Queen Join Date: Sep 2007 Location: Las Vegas! Posts: 880	Good links byrdie714. I just want to point out again, that the implant THEMSELVES do not cause meningitis. It's the surgery. If doctors do not prep the incision properly, or neglect to obey the laws of the OR (keeping every damn thing around the surgical site sterile...which sometimes is an tough task!), etc. The only way that bacteria can get inside the site is if something else that is not considered sterile. I've seen dogs and cats get bad infections from a SIMPLE spay/neuter surgeries. While they have survived with better cleansing, infections still happens. However, now with Vaccination requirements, the risk is very small. Correct me if I'm wrong - I think if children were implanted, they're more at risk than adults due to immune system. __________________ Missing my beloved cat, *Blackjack*, who died from battling with FIP. April 2008 - Feb. 5th, 2009. LEFT: Implanted: 1/10/08 Activated: 2/1/08 Freedom RIGHT: Implanted: 5/15/08 Activated: 6/13/08 Freedom http://cyborgqueen.blogspot.com

02-17-2009, 11:19 AM	#14 (permalink)
etalton Registered User Join Date: Jul 2008 Location: Eastern North Carolina Posts: 781	I don't know about AB, but Cochlear claims they have a 1% failure rate on their implants from what I read. Not bad odds. __________________ E.T. Left Ear Implanted 11-07-08 (Nucleus Freedom) Activation 12-18-08 Right Ear Implanted 3-3-2010(N5) Activation 3-11-10 http://et-mybionicjourney.blogspot.com/

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02-17-2009, 01:02 AM	#2 (permalink)
Hear Again Each day is a gift. Join Date: Jan 2005 Location: Wisconsin Posts: 20,107 Blog Entries: 6	It's impossible to compare the failure rates between Cochlear and Advanced Bionics since they use two different ways of reporting implant failures. I can't explain what they are; all I know is that they are different. If by chance you experience an implant failure, you can be re-implanted. Having said that, I think all CIs (at least those from Cochlear) have a warranty of 10 years. As for the risks of CI surgery, they are no different than any other: adverse reactions to anethesia, dizziness, nausea, numbness near implant site and/or tongue, taste disturbance that may be temporary or permanent, headaches and tinnitus. I would talk to your CI surgeon further if you are deemed a candidate for more specific details as to what you can expect from surgery.

02-17-2009, 01:40 AM	#4 (permalink)
overthepond Registered User Join Date: Jun 2008 Location: Great Britain Posts: 1,592	Pretty much same answer as Hear again and ncff07, Both companies (and medel) proved to be great as each other, you cannot be sure about reliablity as they are competing each other so we will never really know the full truth. We are aware that AB had implant recall few years ago but i am sure they learnt their lesson and would be ok. They all have well over 90 % reliablity. ncff07, I had the test (nerve response test = NRT) while under GA, I am sure all hospitals does this other wise it would be very expensive to re implant if it doesn't work at switch on. In britian it's standard to stay overnight and x-rayed in the morning before going home with bag of pills (anti inflam, anti bios, painkillers) I think Hear Again or was it someone else did a pre and post CI list and it was very good... it's here somewhere...

02-17-2009, 01:48 AM	#5 (permalink)
Phi4Sius Technology Buff Join Date: Jan 2009 Posts: 408	overthepond - My audiologist was talking about a test that they use to evaluate the hearing nerve with electrodes before considering you to be a candidate for a Cochlear Implant. Is this what you're referring to? Or is that a different part of the process? I was under the impression that testing the hearing nerve with electrodes was a fairly straightforward procedure that didn't require general anesthesia. They just place electrodes next to your ear drum, neck, and back of the head to measure the electrical response/viability of the nerve for the potential success of the implant. I could be wrong...

02-17-2009, 02:02 AM	#6 (permalink)
overthepond Registered User Join Date: Jun 2008 Location: Great Britain Posts: 1,592	http://www.alldeaf.com/hearing-aids-...gery-tips.html found it! OP, No, the one you described is called ABR (Auditory Brain response) (completely painless and you would need to be very quiet. As for NRT you need Coil and Implant. NRT is quite unpleasant as it tests higher than your threshold at switch on hence it's best to be done under GA and also to test if the Implant is working correctly. I had another one a month ago, it wasn't too bad as my thresholds are within my max nerve response levels.

02-17-2009, 04:25 AM	#7 (permalink)
Hear Again Each day is a gift. Join Date: Jan 2005 Location: Wisconsin Posts: 20,107 Blog Entries: 6	Phi, When I was evaluated for my CIs (both times) I was given an ABR. The test was quite simple. All it involved was placing electrodes on my forehead, leaning back in a comfortable leather chair and relaxing quietly while the ABR machine did all the work. It was completely painless.

02-17-2009, 04:32 AM	#8 (permalink)
Hear Again Each day is a gift. Join Date: Jan 2005 Location: Wisconsin Posts: 20,107 Blog Entries: 6	I was referring to the internal implant -- not the external processor. Sorry for the confusion. Most hospitals test a CI to make sure it is functioning during surgery before suturing. I know my hospital did although my CI audis (I had one audi for my first CI and another for my second whom I'm still working with) were not the ones who tested my CIs. They were 2 different audis I've never met before.

02-17-2009, 11:50 AM	#15 (permalink)
faire_jour Registered User Join Date: Apr 2008 Posts: 4,922	AB calls every implant removed a failure, Cochlear only calls the ones they find a mechanical problem with a failure. That being said, I only know about the rates for children. 1 in 10 children will need to go back in for another surgery. The rate for adults is lower. This includes ANY kind of revision surgery. The highest complication is not menengitis, but skin flap issues. My daughter's ENT and audiologist say that it is a very serious complication, and the most common. So, DON'T WEAR YOUR MAGNET TOO TIGHT!!!

02-17-2009, 12:15 PM	#16 (permalink)
overthepond Registered User Join Date: Jun 2008 Location: Great Britain Posts: 1,592	Faire jour is right about having magnet on too "tight", magnet being too tight would restrict blood circulation surrounding the area of the skin over the implant. U can tell as it would ache, bit like sitting on one leg too long. I find my magnet a bit loose probably due to my hair is getting longer and thicker, it had been 7 months since my operation and i had massive area shaven off!!!! I have a spare magnet of extra strength now so i can use it while i am sailing/riding horses/skiing for extra security but i always change them back straight away.

02-17-2009, 12:20 PM	#17 (permalink)
ncff07 Registered User Join Date: Jan 2009 Posts: 1,402	i was told by the surgeon the muscle/tissue on my head is rather thick and when i emailed my audiologist about this she said she knew the surgeon had recommended a strong magnet and that she had already ordered 2 of the strongest ones since they dont normally keep those in stock. i could have told them that before the surgery, ive always been hard headed!

02-17-2009, 12:27 PM	#18 (permalink)
deafaussie Registered User Join Date: Feb 2007 Location: Orange County, CA Posts: 304	My right ear was implanted with Cochlear CI24 Contour 10 years ago and was told by my surgeon prior to surgery. Prior to closing skin incision, test equipment 'tests' the internal device to ensure it is functioning according to the manufacturer's specifications. Two years ago, I had a tour in Cochlear manufacturing facility in Sydney, Australia and I was surprised that these internal implants are over engineered, designed and built to withstand 75 year lifespan under normal conditions. Ask your surgeon about the test.

02-17-2009, 06:23 PM	#20 (permalink)
Hear Again Each day is a gift. Join Date: Jan 2005 Location: Wisconsin Posts: 20,107 Blog Entries: 6	I went from having a #2 magnet down to #1 due to illness and having lost weight. I now weigh 114 pounds, but can waver between 109 and 120. As a result, I end up changing my magnet several times a year.