Category Archives: Med-El

Cochlear Implant Surgery Risk

So today I looked on the FDA’s Web site on cochlear implants. I was particularly interested in finding out what all the risks are and if anyone has died from the surgery or the cochlear implant itself.

The risks the FDA lists are:

  • Injury to the facial nerve. I knew about this one. My audiologists told me that they take a CAT Scan for this purpose. They want to know if you have any abnormal facial nerves and they want to know where they are. This way, you know your own unique personal risks before you go into surgery as the doctors will sit down and discuss them with you. So they already know where the nerves are. Not only that but they will monitor them during surgery. I think because of this, there is probably less and less of a risk of this actually happening, particularly if you have a good doctor and good genes.
  • Meningitis. I don’t think I’m at risk for this. It sounds like it’s mostly in children up to five years of age. I couldn’t find the exact years, just studies done on that age group. So I don’t know if anyone older has gotten meningitis as a result. But basically if you give the kid a vaccine before surgery, and monitor for the symptoms of meningitis then it should be fine. But then again, parents should be doing these things for their children anyways (hearing or deaf!). I found a study done in the United States on the risk factors. (see below). The number of cases in Clarion users (and two deaths) in this case (of 18,000 surgeries of 60,000 total out there) was a concern among professionals. It was found that the higher risk was because of the “positioner” part of the implant – a positioner is meant to keep the electrodes in place and position them during surgery. The Clairon with the positioner has since been voluntarily recalled and is no longer made. The FDA did not recommend re-implanting children who already had these implants. Remember that the below numbers are from 2002 and are a bit old. There has been another study done in 2004 using the same people from a 2002 study – I’m not sure if the 2002 study involved in this study is the same one that I’ve been talking about. They found that the individuals who had the positioners even two years after the study were at a greater risk of Meningitis than the rest of the population. Remember that the numbers below are from the 2002 study in the first link I posted. Mel-El doesn’t have a risk in the United States, because not many doctors will recommend it (this is my theory).
    • Advanced Bionics ‘Clarion’-8 cases of 7,271 implant
    • Cochlear Corporation ‘Nucleus’-14 cases of 16,617 implants
    • MedEl Corporation ‘Combi 40+’-0 cases
  • Cerebrospinal Fluid Leakage. The FDA Web site said this was the result of a hole in the inner ear or another hole in the covering of the brain as a result of the surgical procedure. Get a good doctor. I doubt this would happen.
  • Perilymph Fluid Leak. The perilymph is the fluid in the inner ear. I believe it is partly responsible for balance. The FDA said it may leak as a result of the hole they have to make to insert the electrodes. From what it sounded like, my audiologist said that the surgeon will fill this hole with muscle tissue and then your body will heal itself back up. So again, get a good surgeon.
  • Infection of the Skin Wound. Keep it clean, follow the doc’s orders and this shouldn’t happen. If it does you’ll go back to the doc and he/she will probably fix it.
  • Blood or Fluid Collection. Again this is probably something that the doc can fix.
  • Attacks of Dizziness or Vertigo. From what I’ve seen, this will go away as you heal. You just might have to take some pain killers or something. Again, talk to the doc.
  • Tinnitus. This is the one I’m worried about. Some people report more tinnitus. I don’t think there’s a way to fix it, unless you take some medicine. But it’s something that may be a part of your life from then on.
  • Taste Disturbances. Usually these are temporary (that’s what my audiologist made it sound like). I’ve seen articles about how sometimes you can lose taste in half of the taste buds in your tongue. Talk to the doc if you experience this, of course.
  • Numbness. Just like with any cut, scrap, surgery, etc. etc. It’ll be swollen. Ask your doctor when the numbness should go away.
  • Reparative Granuloma. This is inflammation that happens if the body rejects the implant. I’ve heard of docs taking implants out as a result of a malfunction, so I imagine they can take it out if your body rejects it. I have yet to hear about this occurring to anyone. Titanium is well suited for biological things, and your body is not likely to reject it.

So my conclusion so far is that no one has died from the surgery. The only thing a person may die of is Meningitis. I’ll let you know if that is not the case. Also, the surgery is pretty low risk. For the most part, complications can be corrected.

**Again, I am not a medical person. This is why in most every risk I list here, I recommend that you talk to your doctor. So even if I say it may be temporary, I don’t want you waiting for it to go away. Listen to your doctor and talk to your doctor about both the risks before surgery and if you’re experiencing them after surgery. I have found that it’s good to have an idea of what the risks are so you can have more questions ready for your doctor. That is my purpose of posting this list in my blog.

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A Visit with an Audiologist – The Pre-Determination Process

My husband and I went in for our audiologist appointment on Friday – nothing says romance when you get your assistive listening devices check out together! I waited patiently while he went first. He just got two new behind-the-ear (BTE) hearing aids for his moderate hearing loss and needed to get them adjusted. We left for lunch and came back later to talk with a different audiologist who specializes in cochlear implants.

So we came back from lunch to meet with the audiologist. There were a lot of things I learned that I didn’t know before and some things I learned about even though I heard about them (she just made them make more sense). I expected to walk in there to be whisked away for the hearing test and THEN ask the questions. But she sat us down and just talked first. My husband and I just racked our brains of all the questions we could think of and asked her. We must have been there for two hours. Time wasn’t important, understanding was. First off, she really put us at ease, well me anyways at least. I think the fact that she could answer our questions with more information than what we had, was wonderful. She understood our concerns with the surgery and the outcomes of getting a cochlear implant. She understood the propaganda that was going on out there with both people in general and the cochlear implant companies. Not only that but she has told us not to worry about work, scheduling the surgeon, insurance, etc., etc. she would take care of all that stuff. It was up to us to make that decision: that is the only stress we have at the moment, which is such a relief (I have a huge dislike for dealing with insurance people – I’ve done that in the past, and I don’t look forward to doing it again) .

One of our questions was: How fast would this all take? The reason why was my job contract ends at the end of December. It may be renewed again, but it may not and if it doesn’t, I would lose the insurance I have and have to start all over. The answer she gave came as almost a shock to us. One of my other concerns was that I didn’t want to miss that much work.

She told us that we could get the CAT scan, blood work, other testing, surgery, mapping and (I think) a secondary mapping all in a week and a half. The incision that the surgeon would make would be so small that the swelling wouldn’t be that bad and thus the magnets could attach the very next day (the one that’s under my skin and the one that would go on the outside would be able to attach together). There isn’t anything postponing the activation date except the swelling of the skin. The incision that would be made would only be about two inches and would go behind my ear.

Our next question was: which implant? There are three major cochlear implant companies: Cochlear, Advance Bionics and Med – El. She told us that Med-El was really behind in CI technology (and they look ugly – my audie said they look like a gun), so that was off our list right away. Advance Bionics has had three recalls total. They provide a range of colors for the external piece and rechargeable batteries. Cochlear hasn’t had any recalls and they have a disposable battery as well as (I think) rechargeable ones. The quality of sound is pretty much the same for either AB or Cochlear.

The next was: am I a qualified candidate? We told her I had meningitis when I was two. That worried her a little because if you get meningitis then bone may fill up the cochlea and thus I can’t get one. That’s when I went to get my hearing test done. If I respond at all to the hearing test in my right ear (that’s the one I would get implanted), then I shouldn’t have that problem. I did respond and the audiologist declared me a candidate.

Next steps: My audiologist is calling my insurance company for approval, she is also talking to the surgeon about my case and says she will get back with me. In the mean time I can e-mail her as many questions as I want (which I fully intend to do!). I will let you know what happens.