The Bionic Sound Project

this girl’s journey to sound

My Favorite Martian, and the MAUDE database Sunday, November 5, 2006

Last night, I had my first true case of vertigo since surgery #2. The dizziness last night was similar to the dizziness that occured in the 9 days between surgeries #1 and #2.

I was sitting in the chair next to my computer, listening to music and flipping through CDs, when I felt the implant “seize up”. It was odd, as I hadn’t worn the CI all day, so I don’t know why it felt like there was stimulation. Then I felt something that I can only describe as a spark of pain that shot through my head. I looked up, but the room was spinning to the left, and I nearly fell out of the chair, but grabbed onto the desk just in time. Immediately after that, I felt like I was going to throw up, so I just laid down for an hour, to settle my stomach and nerves, and to try to get the implant to stop “twitching”. I felt pressure on the the right side of my head, specifically the sides of my forehead and lower jaw, as if somebody was pressing very hard with their finger into the bone, giving me a headache. It was scary to experience something I haven’t experienced in 3.5 months. I had hoped and thought that I would never have to experience that again with the CI, as that problem had been resolved with the 2nd surgery.

I called my mom to tell her what happened, and the first thing she does is to start laughing. Apparently, the whole incident reminded her of the 1960s TV show “My Favorite Martian”. She said that maybe my favorite martian was talking to me, and delivering electrical impulses. She thinks I probably got zapped by something, and to not worry about it. She apologized for laughing, but the way I was telling her about it, sure reminded her of an episode, and I was laughing at her, because it was so random. She told me to look up other shows from the 60s of that same nature such as My Favorite Martian, My Mother The Car, Mr. Ed, Car 54, Where Are You?, etc.. We are goofy like that.

Anyway, I was searching to see if similar events had happened to other CI users before, when I was reminded of the MAUDE database while searching.

The FDA has a database called the Manufacturer And User Facility Device Experience (MAUDE), in which they keep track of things that have gone wrong with medical devices. I stumbled upon this database back in July, when I was searching to find out more about what happened with my cochlear implant surgery. The database is only updated quarterly, and it was just updated so my case is now in there.

Adverse Event Report

ADVANCED BIONICS CORPORATION HIRES 90K COCHLEAR IMPLANT

Model Number CI-1400-01
Event Date 07/19/2006
Event Type Injury
Patient Outcome Required Intervention;
Event Description

A ct scan revealed that the electrode array was in the semicircular canals. On july 19, 2006, the patient had revision surgery to reposition the array. The device remains implanted.

Brand Name HIRES 90K
Type of Device COCHLEAR IMPLANT
Manufacturer (Section F)
ADVANCED BIONICS CORPORATION
12740 san fernando rd
sylmar CA 91342
Manufacturer (Section D)
ADVANCED BIONICS CORPORATION
12740 san fernando rd
sylmar CA 91342
Manufacturer Contact
joann rizzi, specialist
12740 san fernando road
sylmar , CA 91342
(661) 362 -4652
Device Event Key 735215
MDR Report Key 747434
Event Key 712299
Report Number 2029203-2006-00527
Device Sequence Number 1
Product Code MCM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Audiologist
Type of Report Initial
Report Date 08/14/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 08/14/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date 06/30/2006
Device MODEL Number CI-1400-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received 07/19/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured 06/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? Yes
Type of Device Usage Initial

Database last updated on September 29, 2006

And I couldn’t find an answer to my question, plus my friend Matt had come over to check on me to make sure I was okay because I was talking to him and Krista when it happened. I will have to wait till Monday when I see Mandy.

But I’ve got a new headache and some dizziness (not like last night’s) again tonight. I haven’t worn the CI since I took it off at 2 am Saturday morning. This is not fun.

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Cochlear Implant Surgery #2 Diary and Photos Wednesday, July 26, 2006

Here are the pictures and the diary of my experience from Cochlear Implant Surgery #2, that I’ve been promising to post for awhile!

Link to Surgery #1 diary and pictures (July 10-12)

 

In the car on the way to the hospital for cochlear implant surgery number 2!

Tuesday afternoon, the results of the NRI test and CT scan determined that I needed to have surgery again to fix a minor complication with my implant (easily corrected). I am the first patient EVER in all of his years of practice to have this problem. He’s heard of it, but he’s never seen it happen, so it was kinda cool being a doctor’s first case. He definitely won’t forget me!

However, I felt bad because everybody at the office was waiting for us to come back from the CT scan till after closing hours, because they needed to see the results on whether or not surgery was needed, which I wouldn’t find out until the next morning when Myrna, the secretary/coordinator, came in.

Wednesday morning, 10 minutes after they opened at 8:30, everything was in place and all set to go. I was going to have surgery at 5:30 pm on Wednesday afternoon, same hospital as my first surgery.

(more…)

 

Cochlear Implant Surgery Part Deux Wednesday, July 19, 2006

It’s been confirmed as of this morning. I’m having my cochlear implant surgery again this afternoon.

They’re going to take my implant out and redo it. If that doesn’t work, they’re going to put a new implant in.

But this explains all the dizziness that I’ve been having (I’ll explain later with a medical picture). I just hope I don’t barf up blood like last time.

 

It’s Been Done – Surgery! Thursday, July 13, 2006

I had my cochlear implant on Monday, July 10th. I’m fine, but I had a really rough time with it, and ended up staying in the hospital for almost 2 and a half days. I’m at home now, and I’m doing okay, but not that great. I’m making this entry very short and will update more later.

My surgery was around 7 am, and I didn’t get moved up to a hospital bed until around 2 pm, I believe. I was very sick and having a lot of trouble with post-anesthesia issues.

Here are some pictures from my experience (on Surgery Day and the two days afterwards)

 

My Dad and I at Good Sam around 4:50 am

 

(more…)

 

After Surgery Update Tuesday, July 11, 2006

Just a quick post since I’m not coherent (but the most coherent I have been since coming out of surgery).

I’m alive, I made it.

I’m hoping/probably going to stay here an extra day, because I have been soooooooooooo sick. Between a bad reaction to the anesthesia, and the fact anytime u have surgery done on the inner ear, it affects your balance/makes you dizzy. Between those two, I’m having a lovely time.

Much thanks to Alex for the suprise visit and the beautiful roses you brought me.

I’m getting really tired now, so talk to you later.

P.S. I was mad last night when they brought me “real” hospital food, and I wasn’t able to eat any of it. Man, the chocolate mousse, bread, milk, mashedpotatoes, green beans, and salad I wanted. Heck, everything but the mystery meat.

Not looking forward to breakfast, since I hate breakfast, haha.

 

The Big Day Soon Arrives…(T-10 hours) Sunday, July 9, 2006

Tomorrow’s the big day. Just less than 2 hours till the magic midnight hour of no more food or drink. 9 hours and 17 minutes till I’m on the table (at 7:30 am), having a hole drilled into my head, and part of my skull hollowed out.

The surgery itself will take an hour, but there’s an hour after the implant, where they test it to make sure it’s working. If it isn’t, then they take it out and put the backup implant in. The only wish I had would be that Megan would be there, instead of the other audiologist, since I haven’t met Kim yet and feel nervous about that.

Right now, I am on the verge of freaking out. Earlier today, I was thinking about not going through with it. Then I realized it was ridiculous to come this far and spend ALL this money and time only to go, “oh wait, I don’t want to do this after all”, especially for insignificant reasons due to my anxiety of it all.

I’m not scared about the surgery itself. I’ve got competent and excellent doctors behind this, who are working together. I don’t have to worry about bleeding, because they know what to do to treat that if it happens. Rather, the biggest thing that I’m scared of is what happens afterwards. What is it going to be like? Am I going to regret this? What is sound going to be like? Am I going to hate the way the world sounds, and prefer my hearing aids to this cochlear implant?

I’ve got my doctors and every person that I have undergone tests with, who have looked at my audiological history and said “you are an excellent candidate”. Some of my friends, who have gotten their implants recently, absolutely love theirs and are doing well with it. But I have this feeling that if something were to go wrong, I would have SO much more to lose.

Right now, I’m sitting here typing up my thoughts and playing all my favorite songs, even cheesy ones like Hanson’s “MMMBop”, which just popped up on my list. I want to memorize the sounds of my favorites one last time before I lose all my “natural” hearing in the right ear.

I don’t know how I’m going to survive one month without sound in one ear. Music and sound have always been a part of my life, since I first put my hearing aids on at 4 months old. I have a long road ahead of me in learning to “re-understand” sound. I know that once I get activated, it’s not going to be the same as the hearing aids, and I have to keep reminding myself of that fact.

This is the moment where I need to take a leap of faith and just DO it. That’s been my whole life…taking a leap of faith and hoping for the best. It hasn’t failed me yet.

5 am, here we come. Bring it on.

 

Audiological testing and a curveball has been thrown into the plans Thursday, June 22, 2006

Oh. My. GOSH. Talk about a total curveball in your plans. They’ve moved up my CI date to the 10th or the 12th instead of the 26th.

I met with Megan today (the audiologist) and she gave me some hearing tests that I hadn’t had at school (specifically, the HINT test, among some others). For me, the results were shocking, and in a way, a real eye-opener.

11% on sentences spoken in a noisy environment, no lip-reading.
24% on sentences spoken in a non-noisy environment, no lip-reading.
08% on words spoken in a non-noisy environment, no lip-reading.
100% on sentences spoken with lip-reading in a quiet environment.

The words that I got right? The, and, of, (and so on) consistently. That is what makes up the 11%/24%. And one word…I think it was something like “watched”.

All I have to say to this is that some of my friends will remember the “bastard pony” misunderstanding from my recent birthday party. The results of these tests are a perfect example of how I can hear speech but not understand what is being said.

The basic fact remains that I, without any source of lipreading, am DEAF. I will continue to be deaf even after the implant, but hopefully we can bump up my comprehension level to that of a hard-of-hearing person or better. I can play the part of understanding everything, but I am not hearing and understanding everything that is being said. I hate group conversations with friends or family, because I can’t follow everything, and people don’t slow down or look at me to help me to understand. This is why I space out a lot, because my brain gets tired from trying to fill in the missing words and to understand what is being said. That’s why I feel left out or not a part of things a lot.

So with the results of those tests, along with some big questions that were answered today, I am basically an excellent candidate for the CI. At this point in time, I am definitely a GO for surgery (except for the clearance from the hematologist). I can’t wait to get it, but at the same time, I am scared to death, because my life as I know it will change. What I used to know as sound in the world will be opened up to greater heights. Some things I will have to do differently, won’t be able to do, or ever get a chance to try (metal detectors, MRIs, scuba diving). That, and having a hole drilled into your head is scary enough.

The other thing that was mentioned today was that my surgeon has had several patients who have come back after surgery and were able to wear a hearing aid because their residual hearing wasn’t destroyed! The reason for this is because the implant didn’t go past the apex of the cochlea, so those low-frequency cells were still present. There is no guarantee that will be the case with me, but let’s hope that I will have some low frequency hearing after surgery, because that will help in an environment without my hearing aids.

So yeah, two weeks till surgery. I still have three more appointments to do: speech therapist, hematologist, and then my pre-surgery appointment.

Bring it on.