Recall!!

Things just get better and better! LOL
Advanced Bionics has voluntarily put out a recall on their implants. Scary thought huh? Once you think of all the aspects of this... not so much. Their last recall was in 2004 but no one was affected that already had the surgery. I will post their announcement for this one here...

**** Recall Notification****

Advanced Bionics HiRes 90K Cochlear Implant

Dear Cochlear Implant Recipient or Parent,

Our mission at Advanced Bionics is to improve the lives of the hearing impaired, and the

safety and well-being of our recipients is our first priority. Because we are committed to

ensuring that our products are as safe as possible, we are voluntarily informing you that

we have become aware of an issue with the HiRes 90K cochlear implant. The issue can

result in pain, overly loud sounds, and/or sudden shock sensation in the implanted ear

while the implant is receiving power. Thus far, our investigation shows that of the more

than 28,000 implanted HiRes 90K devices, only two explanted devices have been

confirmed to have this issue. There are 9 other patients with similar symptoms which

our investigations have not yet ruled out as related to this issue. For the two confirmed

cases, there were no symptoms upon initial activation of device. However, the patients

experienced symptoms after 8-10 days of use. Both recipients were re-implanted with

HiRes 90K devices and their clinicians report that they are progressing well.

We are conducting an extensive investigation of this issue using an independent

scientific research organization. Their current analysis suggests that, if present, the

issue will first occur within 90 days of device use. However, the onset of symptoms may

be delayed after initial activation, and they may continue to occur intermittently. In the

unlikely event that this symptom occurs, continued device use may lead to damage to

the inner ear and/or the auditory nerve. If you or your child experience pain related to

implant use, remove the external equipment immediately and contact your cochlear

implant clinician to schedule an appointment. If the evaluation of your device identifies

this problem, device replacement is advised.

It is important to note that it is not unusual for cochlear implant recipients to experience

overly loud sounds. Most of these cases can be resolved with standard troubleshooting,

such as the replacement of external equipment. The vast majority of these cases are

not signs of the issue described above and do not require explant of the device. We will

notify you again as more information from our investigation becomes available.

We sincerely regret any concern this notification may cause. Advanced Bionics assures

you that we will correct this issue and continue to improve our product reliability.

If you have any questions regarding this letter, please contact an Advanced Bionics

representative at 877-577-4628 (telephone) Monday – Friday 5:00 a.m. – 7:00 p.m. PST

or www.advancedbionics.com (live chat) Monday – Friday 5:00 a.m. – 7:00 p.m. PST.

In order to assure the effectiveness of this communication, please complete the

enclosed acknowledgment form and return it to us at your earliest convenience by using

one of the following options:

E-mail: confirm@advancedbionics.com

Fax: 661-362-7621

Mail: Self-Addressed stamped envelope

I am impressed with this company. They CARE about the people using their product. All surgeries since this recall have been canceled until they find the source of this problem. It was only 2 people out of 28,000. I'm not sure the other companies would do this. I love the fact they keep us informed.

I wanted to have this done ASAP even though the process is long and it's possible they will be producing implants before I am approved. This is just one more "bump in the road" and I am hopeful they will find the cause soon.

BEA Meeting

Tomorrow afternoon there is a BEA (Bionic Ear Association) meeting in Orlando. I WILL be there. I am stressing the "will" because it is something I just have to make myself do. I never thought something so simple would be so hard!

My new found friends at HJ (Hearing Journey) have helped to make it a bit easier. They are the only people that really understand how I feel because they have been or are in my shoes. The isolation that takes over your life when you lose your hearing is crippling. It is so hard to explain to hearing people because they can never get the real effects it has on you. I am no longer the person I use to be and I do not like the new "me" but there is nothing I can do to change that but hope. My life is in the hands of others that are not real concerned about it.

The Wait Gets A Little Longer

I got a letter Friday from my counselor at Vocational Rehab. She has made me another appointment with the audiologist for more testing. When I was at the audiologist last month, she told me she had all she needed. So I emailed her to ask if I needed to see her on the 19th of Nov. She says she talked to my counselor but they require more testing. She told me not to worry it wouldn't take long because she already knows the results but it's another hoop I have to jump through. I think I have a long wait ahead of me. We shall see..

The Waiting Game

This will probably be the hardest of all for me. I wish I had more patience but I'm not asking for that. If I asked for patience, God would TRY my patience to give me more and I certainly don't need that! There are many "waits" in this process. The wait for approval, then the wait for a surgery date. The wait for the surgery and then the wait for activation. Activation is the day the journey begins.

That is the day we start to get answers. Some people start hearing right away (although not normal hearing) while others it takes time to retrain the brain to hearing sounds. It is something that you have to work at and I plan to do all I can to make the most of this device. I wonder how long my wait will be...

What It Looks Like

This is what is implanted inside the head. The nickel is there for comparison size. The string looking thing is what is placed down into the cochlea. The gold part is the "brains" and the other end is the magnet that the disk will stick to that sends info to the processor.

This is the complete set up. The BTE (behind the ear) has no ear mold so I think comfort is going to be better than a hearing aid. Instead there is a T-Mic which just hangs right in the opening of the ear which allows you to put a phone right up to your ear or wear headphones like anyone else. The blue disk will be stuck to the side of my head which connects the "brains" to the processor. I was trying to upload a picture of how it looks on but I am not getting that done! I shall try again another day.

You can watch an actual video of the implant surgery at this link if interested.
http://www.or-live.com/distributors/NLM-Flash/uho_2419/rnh.cfm?id=844

Getting Started

Last week was my first appointment with the doctor to decide if I was a candidate for the surgery. I already knew I was which he confirmed and set up an appointment this week with my new audiologist. He gave me a packet of information about AB (Advanced Bionics) implants to look over until I met with the audi. She will answer any and all questions.

As soon as I got home, I read every word. I didn't even know before this point there was more than one implant. I had a lot to learn! The more I read, the more questions I had. Very overwhelming! Among this packet is an online group of CI (cochlear implant) users. The HearingJourney.com has been my saving grace. I highly recommend anyone going through this at any point take a look there. There is a wealth of experience and information there. The support is incredible because no matter where you are in your journey, they have been in your shoes and KNOW what it is like.

My appointment with my new audi was a success yesterday. She is a wonderful person and had all the time I needed. I was there over an hour asking questions and didn't even realize I was there that long. When I left there, I had more choices to make. This is a once in a lifetime decision and I have to be sure to make the right choices. I have discussed these choices with people from the Hearing Journey and am comfortable with the choices I will make. Their experience is so comforting.

Once I get approval, I will be getting AB Harmony with T-Mic. I will only be doing one ear so I have decided to do the right. I am confident that once implanted, I will be able to use a phone again along with listening to music and hearing my grandchildren's voices! I am so excited! I am going to be a bionic woman! LOL

My Journey To Better Hearing

A little history..
My hearing loss started about 20 years ago. Not bad but simple things like my kids could not talk to me from the next room. It has been a gradual loss but continued. About 10 years ago, I started wearing hearing aids. They helped in amplifying the sounds but never really gave me any clarity. Speech has always been the hardest for me. And now to the present. I am completely deaf in the left ear and have just a little left in the right but not enough for a hearing aid to help. I am currently waiting for approval to get a cochlear implant. This could change my world!

I'd like to say to any blogger's/people who stumble onto this blog that I am not a blogger. I am not a writer. I wish I were because I do love to read but writing is just not in my blood. LOL This will be my own personal journey to hearing again..