CI Schedule changes

So... Turns out the surgeon won't be in office the last week of March (when my original post-op and activation appointment would be). So.... it was either move the activation appointment up to March 23, or move the surgery date to the next week, March 21st with activation/post op on April 3. Well, my boss was getting some time off in March too, taking off when I was back in at work and that sort of thing. After she made some phone calls and such, the end result was us switching our weeks off from work. So now my new cochlear implant schedule looks like this:

Pre Op: 3/20/12 @ 1:30 pm
Pre Admit: 3/20/12 @ 3:00 pm
Surgery: 3/21/12 @ 12:00 pm (check in at 10:30 am)
Post Op: 4/3/12 @ 1:30 pm
Activation: 4/3/12 @ 9:00 am

Yesterday afternoon was a bit crazy for myself, and for my boss, figuring out how to deal with the schedule changes and such. Just got the confirmation from the CI center this afternoon. Now just need to get the other boss to make the changes to my requested time off in the system, and I'll be good to go.

Getting closer

It's slowly getting closer and closer to March! Lately I've just been quite eager for the CI dates to get closer and closer. I keep hitting up the Advanced Bionics website and scoping out their color and accessory options, trying to decide which color and accessories I'd want, that sort of thing. Even pulled out the Advanced Bionics info packet I received from AB quite some time ago about the Harmony device. Even have a notebook that I'm using just strictly for the cochlear implant, where I keep track of questions I want to ask, notes of colors/accessories I want,

The follow up with the CI surgeon is Feb. 24th (where we talk of the surgery and that sort of thing), and I'll also be informing the center of which implant device I want to get. The audie said she'd have demos for me to look at/play with, so I can get a feel for them. If I do get 2 processors, I'm sure I'll want a Harmony, and a Neptune. I mean, who doesn't want a Neptune? It's a pretty neat device, and it'll definitely come in handy when I'm around little kids in wet settings. I have nephews that love water guns and splashing in the water. My Naida hearing aid barely handled a tiny itty bitty splash last summer (really, I swear, a couple of small drops of water on the hearing aid and the next day it was acting funny until I ran it through the Dry n Store!). I would even be more willing to get into a swimming pool with a Neptune and go swimming. I've never liked the fact that I've had to take off my hearing aids and put them away before getting wet, especially when swimming with friends and family (not being able to hear has stopped me from willingly getting into a pool for the most part, I want to hear what's going on around me!).

Pre-op and pre-admissions is set for March 13, surgery for March 14, and activation and post-op March 29th. I've been researching cochlear implants, and even working at getting one for about 10 years now. I'm glad it's finally going to happen!  I've even already gotten the pneumovax vaccine last week, just to get it out of the way. I'm getting excited about this!

Got some tentative dates for the CI

Got an email from the surgery/appointments coordinator at the CI Center with the tentative dates for CI surgery.

Follow up appointment- 2/24/12 @ 10:45
Pre Op- 3/13/12 @ 11:30
Pre admissions- 3/13/12 @ 1:00
Surgery- 3/14/12 @ 7:30 (Check in would be at 6:00 am)
Post Op- 3/29/12 @ 10:45 am
Activation- 3/29/12 @ 8:30 am
 
Am seriously hoping I can stick to these dates, but of course have to double-check and such, make sure they work out.

Did I just hear 'principal punch'?

Had a quick hearing test with the CI audiologist today. She was making her trip through Wyoming to meet with clients for mappings and such, and agreed to do a quick hearing test with me. Originally I was to go to Cheyenne tomorrow, but then I found out she was coming HERE the day before. So I went to the special education services building and was directed to the audiology office. The school audiologist is excited that I'm working on getting the implant. He made a copy of my Medicare and Medicaid cards for the CI audiologist since she wanted to take the copy back to her office to add to my file. The CI audie and I went into the soundbooth. Took her a few minutes to get her laptop up and running. She pulled up a program and we got started. It was just a quick test, not a full-out test with beeps and tones. Just sentences. And these were difficult sentences, oh my goodness! And there were different voices being used too (male and female). I understood the female voices better than the male's for the most part. I got maybe 2 full sentences right on, but all the rest were a bunch of mumble-mumble-WORD-mumble blah blah blah blah what?

One sentence said something about personal touch like "I'm going to add some personal touch" or something like that. I could've swore it said "principal punch." Anyway, we did 2 different rounds of sentences. First round, I got 7%, second round, 21%. Well, I definitely meet Medicare's criteria for cochlear implant coverage! CI Audie and I talked some more, trying to work out a plan of some sorts. We're going to shoot for a March/April surgery date for the cochlear implant. I'd rather do it sooner, but I'd have to travel to Denver, and with the holidays and winter coming up, I decided it'd be better to wait until early Spring.

When the audie gets back to Denver, she'll speak with the surgeon and see if we can schedule the initial visit with the surgeon and the pre-op into one appointment, so I wouldn't have to make two separate trips. She also mentioned she was planning to come back here sometime in April, so if we could do the surgery in March, then I could see the audie when she comes here for activation. It would be great if this happened, but we'll see what happens.

My Medicare coverage starts up next month, and they will cover 80% of the implant, and Wyoming Medicaid will cover the remaining 20%. Late last week, the audie had heard that Medicaid wasn't covering implants for adults anymore, but that applies to Colorado. Wyoming Medicaid is still covering them (I confirmed this via email with someone from Wyoming Medicaid's office on Monday and got the update "covered services" manual as well).  Seems like everything's all falling into place for me, finally. I've been working at this for years, since I was in high school. I'm glad I can finally progress with the implant. I'm still going to do the left ear alone, and I'm definitely choosing Advanced Bionic's device as well. Hopefully by spring next year the new Neptune processor will be available. Audie told me I should be able to get 2 processors, so if that's the case, I'd like to have the Harmony for everyday general use, and the Neptune for back up and for being in wet situations (I do have some very young nephews who do like to splash and squirt water guns).

Audie told me I should be hearing from someone from the CI Center's office within the next few days or so, to get things more set in stone/planned out basically.

And now for hearing aid stuff... I see my hearing aid audie later this afternoon to have a new earmold made for the right ear. I don't think the current earmold fits as well anymore. Been more than a year, so it's about time for a new one anyway. Should be fun! Two different audiologists in one day.

Advanced Bionics back on the market in the US

Advanced Bionics Announces FDA Approval For U.S. Market Re-Entry Of The HiRes 90K Cochlear Implant

-- Distribution of HiRes 90K Cochlear Implants in the United States Now Under Way --

VALENCIA, Calif., September 13, 2011 – Advanced Bionics (AB), the only U.S.-based manufacturer of cochlear implants and a subsidiary of Switzerland-based Sonova, announced today the approval of the FDA for immediate market re-entry of the HiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics received approval from several other regulatory agencies, including Health Canada and the European Notified Body, TÜV, to resume distribution of the HiRes 90K implant to Canada and countries accepting the CE Mark.

“Everyone at AB and Sonova is excited that we are back on the market globally. We stand by our commitment to putting patients first and delivering high-quality products for the best possible hearing experience,” said Hansjuerg Emch, Group Vice President Medical of the Sonova Group. “The support we have received across the industry for our integrity has been incredible.”

AB’s first priority is the safety and well-being of patients, which is why it instituted a voluntary recall in November 2010 after becoming aware of a rare issue with the HiRes 90K cochlear implant. Of the more than 28,000 implanted HiRes 90K devices, only two (0.007%) explanted devices were confirmed to have this issue. In the months since the recall was instituted, AB implemented changes to its manufacturing process to ensure that there is no effect on the safety or efficacy of the HiRes 90K cochlear implant.

While off the market, AB actively continued all research and development projects that were under way prior to the recall.

“Our upcoming launches and products currently in development will continue to lead the industry and help our patients hear their best and live a fulfilled life,” said Dr. Gerhard Roehrlein, CEO and CTO of Advanced Bionics, LLC.

About Advanced Bionics

Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Founded in 1993 and working with Phonak under the Sonova Group since 2009,

AB develops cutting-edge cochlear implant technology that restores hearing to the deaf and allows recipients to hear their best.

With sales in over 50 countries and a proven track record for developing high-performing, state- of-the-art products, AB’s talented group of technologists and professionals from all over the world are driven to succeed, work with integrity and stay firmly committed to quality.

To learn more about AB and its revolutionary cochlear implant technology, please visitwww.advancedbionics.com.

Media Contact:

Cheryl Garma

Advanced Bionics, LLC

661.362.1400

MediaInquiries@AdvancedBionics.com

Voluntary Recall Notification for Nucleus CI500 cochlear implant range

Voluntary Recall Notification for Nucleus CI500 cochlear implant range

Cochlear Limited is undertaking a voluntary recall of the unimplanted Cochlear Nucleus CI500 cochlear implant range.
While less than 1% of CI512 implants have failed since launch in 2009 , Cochlear has identified a recent increase in the number of Nucleus CI512 implant failures.   In an abundance of caution and with our recipients in mind, Cochlear has issued a voluntary recall of the Nucleus CI500 range of cochlear implants while it further investigates the issue.
No implants outside the Cochlear Nucleus CI500 range are affected by this voluntary recall including Nucleus Freedom implants which remain available.
The Nucleus 5 external devices (Nucleus CP810 Sound Processor) and any previous generation sound processors are not affected by this recall.
It is important to note that all existing Nucleus CI512 implant recipients can continue to use their system as normal.
If a Nucleus CI512 failure occurs, the implant safely shuts down.  In the event of a failure, recipients can be re-implanted with the Nucleus Freedom implant range which remains available.  Nucleus Freedom is fully compatible with the Nucleus 5 Sound Processor System which is not affected by this recall.
For people considering a cochlear implant, Cochlear recommends the use of the Nucleus Freedom range of Cochlear implants which are fully compatible with the Nucleus 5 sound processor system.  This combination of Nucleus Freedom and Nucleus 5 sound processor system does not sacrifice any of the performance benefits of the Nucleus 5 processor system.
For more than 25 years, cochlear implant reliability has been of paramount importance to Cochlear, and we remain committed to providing high quality, high reliable cochlear implant systems.
We sincerely apologise for any concern this causes.  I f you have any questions regarding this please do not hesitate in contacting your local Cochlear office.

Cochlear shares plummet on product recall

Cochlear shares plummet on product recall

Eli Greenblat

September 12, 2011 - 10:29AM

Shares in bionic ear implant company Cochlear fell 17 per cent in early trade after the global leader in hearing technology announced a voluntary recall of its unimplanted CI500 Cochlear range.

Shares were down as much as $19.41, or 27 per cent, to $52.77. They were recently 18 per cent lower at $60.00.

The Sydney-based company said in an announcement to the Australian Stock Exchange that it had begun notifying healthcare professionals and regulatory authorities about the recall.

Cochlear said the financial impact of the recall was difficult to forecast at this stage.

Cochlear said in its announcement that all existing recipients with a Nucleus C1500 series implant can continue to use their system as normal.

Cochlear said less than 1 per cent of CI512 implants had failed since its launch in 2009, but that it had identified a recent increase in the number of Nucleus CI512 implant failures.

To be cautious the company had decided to recall the Nucleus CI500 range of implants while it investigates the cause of the problem.

Cochlear has implanted its bionic ear device in more than 250,000 people over the past 30 years and the company has managed to dodge the types of problems that have led many of its competitors to recall their own devices due to health-related problems linked to the devices.

Over the past 10 years its key rivals in the United States were forced onto the sidelines due to problems with their own devices, handing Cochlear a clear run to capture a bulk of the North American market. The last time a rival of Cochlear was forced out of the market the Australian company boosted its market share well above 75 per cent.

The affected CI500 implant range includes the Nucleus CI512 implant plus the following implants which are only available in limited markets - Nucleus CI513, Nucleus CI551 double array implant and Nucleus ABI 541 Auditory Brainstem Implant.

Its Nucleus 5 external device range and any other previous generation externals are not subject to this recall.
More than 10 years ago Cochlear was the target of a US Department of Justice investigation into payments made to physicians and providers. No charges were ever brought against Cochlear or any of its executives.

The company recently unveiled a full-year profit of $180.11 million, up 16 per cent, as revenue increased 10 per cent to $809.6 million.

Continued technological innovation has helped Cochlear maintain its dominant market share in the implant industry, with its Nucleus range of implants touted as the next generation series of devices that would help Cochlear stay ahead of its competitors as well as encouraging greater take-up rates among doctors and patients.

egreenblat@theage.com.au