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We face odds every minute of the day…

March 31st, 2008 by | Tags: , | 19 Comments »

When we get in the car, whether we are a passenger or a driver, we are at risk of getting into an accident and becoming paralyzed. If we live in Florida during hurricane season, we are at risk of experiencing a hurricane and losing all our property. If we live in or travel to California, we are at risk for earthquakes. People choose not to travel to Israel because of the possibility of violence. Children play with toys that possibly have lead and thus, they’re at risk of harming themselves. People eat spinach that could possibly have E coli or beef that could possibly cause Mad Cow Disease. People could choose to avoid roller coasters because of the possibility of accidents. And, finally, deaf people could choose not to get an implant because of the possible risks.

We face risk every day in our lives. If we stopped to think about all the possible risks, we couldn’t get our minds around it all. We would certainly make ourselves crazy if we worried about all the possible risks. If we choose to avoid all possible risks, we would have no life, and we would be just sitting in a chair and drinking some tea all day long.

I’m amazed by how certain people in the deaf community love to nitpick, make possible CI risks a major deal and look at them as a half empty glass while the risks are usually avoidable, fixable, and improvable, and companies, surgeons and audiologists who are committed, and committed parents are willing to take every step necessary to protect the health and well being of CI users. Advanced Bionics voluntarily recalled their devices by sending out letters to all the AB users and was willing to foot the bill out of their pocket for reimplantation. This demonstrates how AB was open about their failure.

When I was going through two implant failures, rather than just sitting and whining at the CI company that it was not fair that I had to go through two failures, my parents made contacts with various people to make sure that we were pursuing the right direction with reimplantation to ensure that my reimplantation would go well. From my personal experiences, I know that Cochlear, whose implant I have, is committed to researching what causes CIs to fail and is willing to take every step to improve it. Cochlear requires surgeons to send all of the failed internal implants to their research group in Sydney so that they can find out what caused the failure and figure out how to prevent the same failure in the future. My first CI failure happened because the silicone seal between the electrode array and the receiver ruptured. My first implant was one of the very early ones, and Cochlear had already identified the weakness in this area and corrected the problem many years before my first failure occurred. Even with my first CI having that area of identified weakness, it still lasted over 13 years, and I know others whose CIs are from the same period and are still going strong over 20 years later.

Neither Cochlear nor my surgeon knows the cause of my second CI failure. The explanted internal part of my implant was sent to Cochlear’s research group, and they were still unable to find the cause. However, I’m confident that they continue to research the causes of failures as they strive to improve their products and the lives of deaf people who want to hear with cochlear implants. When I was at the Cochlear convention last year, a cochlear implant engineer from Australia gave a fantastic presentation on how Cochlear manufactures their cochlear implants. He said that at least HALF of the cochlear implants that are produced are THROWN in the garbage because they are not perfect. They test every single one of their internal implants thoroughly to ensure its best quality.

So, as I said, there are so many risks we face every minute of the day. Should we not allow children to play with toys at all because of the risk of lead or choking hazards? Should we not go to Florida and enjoy the sunny beaches because of possible hurricanes? Should we not drive at all because we could face the risk of becoming paralyzed if an accident occurs? Should we not have fun screaming through the roller coaster ride? Instead of complaining and avoiding every possible risk, let’s work on striving for improvements and better quality of life.

Car manufacturers are always researching to refine the quality of cars in order to prevent serious injuries in accidents. Toy companies strive to improve the quality of toys to ensure that children can play with them safely. Builders in California and Florida strive to enhance the quality of homes to prevent the loss of life and property. Food manufacturers strive to improve the quality of food to ensure that we’re eating safely. CI manufacturers are in the same bucket as all these other businesses.



March 31, 2008 at 9:33 am

Good point! Another thing people often worry about is the “CI increases meningitis” risk. I asked a CI surgeon about this, and he said that the population of people receiving CIs is already a high-risk population for meningitis due to factors like previous meningitis, abnormally shaped cochlea(s), or various syndromes that cause deafness. Therefore, if a person who happens to have a CI develops meningitis, it is not always the case that it can be attributed to their having a cochlear implant. Because of previously existing risks, it could be due to many things. Fortunately, the meningitis vaccine has made this more and more of a non-issue.

March 31, 2008 at 10:08 am

To each their own…every one of us has the right to choose what risks to tolerate and to define what is unacceptable.

However, the fatalistic philosophy of “everything has risks and it’s all in the same bucket” is dangerously close to the policy that exists in many large businesses: there is always a certain failure percentage that is acceptable in the manufacturing process. To be too demanding of perfection would hold up the process and reduce profits in getting the product to as many consumers as possible.

This is why we still have automotive failures. These are taken into consideration as part of the cost of doing business: a few drawn-out lawsuits taken against billions of dollars in profit. To demand perfection in auto manufacturing would drive up the price of cars to Rolls-Royce proportions and markedly reduce availability of cars to the public.

So we all have to take calculated risks, just as manufacturers do. We need to know all the facts, not to be deceived about them, and based on that information, choose our risks in accepting reasonable cost and availability as a tradeoff.

I’m sorry you had to go through two failures and still face the ordeal of replacements and reprogrammings several times throughout your life in order to be able to hear. Personally, for many reasons, I chose not to accept those tradeoffs nor to tolerate the inconvenience of having a foreign apparatus inside my skull since hearing almost like others is not a priority in my already-full life.

Still, for a medical device that one MUST live with inside one’s body whether or not it works and which is permanent as far as insurance and other agencies are concerned, it is a heavier responsibility on the manufacturer to uphold the trust of its patients and make them right the very first time. This is not like an automobile or any other external, reversible, replaceable product. Hopefully the FDA fine will encourage the cochlear manufacturers at least to try harder for perfection.


March 31, 2008 at 11:42 am

Yes, you are quite right, we all live lives that put us in risk with elements out there. I agreed with everything you said, EXCEPT the allusion that you made when you wrote saying that a Deaf life without implant would equal to having no life, sitting on a chair and drinking tea all day long. I hope that you realise that this is not really true for Deaf people, as they do live their own lives with rich experiences despite the fact that they live without sounds. We could say that we feel sorry for CI users who live their lives without the beautiful American Sign Language. (Imagine living a life without French! Ben non!) I enjoy reading your blogs and getting a different perspective on life, but please remember that Deaf people do also lead rich lives. Anyway, great re-design on your website, I like it!


March 31, 2008 at 12:08 pm

There is a tremendous difference between a cochlear implant failure for unknown reasons and a cochlear implant failure due to the corporation’s failure to maintain strictest quality control required by FDA. Each company stands behind its products. The issue with the AB cochlear is that it sent out inferior cochlear implants, necessitating surgical removal in the future. Every surgery carries its risks, including potential serious complications due to anesthesia.

When I want to purchase an item, I check the reviews of the products and pick the best that I can financially afford. A company already convicted by a regulating agency for not doing its mandatory rigorous testing of products ranks low in my integrity scale, especially if it is a medical device. I don’t care if the company made voluntary recalls and that the cochlear implant devices are replaced at no cost. I do not want to gamble unnecessarily with medical products requiring surgical products, especially with the risks of anethesia. It’s disheartening to see so many people defensive of a company convinced of not maintaining its quality assurance testing due to cochlear implant controversies.

The shoddy products shouldn’t have been released in the public in the first place, endangering the welfare of the cochlear implant users. Hence the whopping fine of 2.2 millions dollars FDA wants to levy against the AB corporation.

March 31, 2008 at 6:24 pm

“OBJECTIVES: To assess a group of consecutively implanted children over 10 years after implantation with regard to implant device use and function, speech perception, and speech intelligibility outcomes; and to document current academic or occupational status. STUDY DESIGN: A prospective longitudinal study assessing device function, device use, speech perception, speech intelligibility, and academic/occupational status of implanted deaf children. SETTING: Pediatric tertiary referral center for cochlear implantation. METHODS: The auditory performance and speech intelligibility development of 30 profoundly deaf children were rated before cochlear implantation and at 5 and 10 years after implantation using the Categories of Auditory Performance and the Speech Intelligibility Rating. The academic and/or occupational status of the participants after 10 years of implant experience was documented. All children received a Nucleus multichannel cochlear implant between the ages of 2.5 and 11 years (mean age at implantation, 5.2 yr). Implant experience ranged from 10 to 14 years of use. RESULTS: After 10 years of implant experience, 26 subjects (87%) reported that they always wore their device; 2 subjects (7%), frequently; and 1 subject (3%), occasionally. Only one child had discontinued use of his device. After 10 years of implant use, 26 (87%) of the children understood a conversation without lip reading and 18 (60%) used the telephone with a familiar speaker. Ten years after implantation, 23 (77%) of the subjects used speech intelligible to an average listener or a listener with little experience of a deaf person’s speech. One-third to one-half of the implanted children continued to demonstrate improvements at 5 to 10 years of implant use. Of the 30 implanted children, 8 (26.7%) experienced nine device failures. The length of time from identification of the first faulty electrode to reimplant surgery ranged from 2 weeks to 5.5 years, as several failures were gradual or intermittent. However, all children were successfully reimplanted. At the end of the study (10-14 yr after implantation), 19 subjects were in secondary school for children aged 11 to 16 years: 6 were in mainstream schools, 7 were in specialist hearing-impaired units attached to a mainstream secondary school, and 6 were in schools for the deaf. Of the remaining 11 subjects, 4 were in college studying vocational subjects, 2 were in a university studying for a bachelor’s degree, 3 were working full-time, 1 was working and going to a university part-time, and 1 was a full-time mother of two young children. CONCLUSION: All but 1 of the 30 implanted children continue using their devices 10 to 14 years after implantation, showing significant progress in speech perception and production. Device failure was frequent, but successful reimplantation occurred in all cases. One-third to one-half of the implanted children in this study continued to demonstrate improvements at 5 to 10 years of implant use. All children are studying or working and are actively involved in their local communities. The results suggest that cochlear implantation provides long-term communication benefit to profoundly deaf children that does not plateau for some subjects even after reimplantation. This study further indicates that cochlear implant centers need the structure and funding to provide long-term support, counseling, audiologic follow-up, rehabilitation, and device monitoring to implanted children.”


March 31, 2008 at 12:43 pm

Hey deafutahhiker,

I was not directly referring to the deaf ASL community when I said “we would have no life, and we would be just sitting in a chair and drinking some tea all day long.” I was referring this sentence to life in general. Of course, we have the right to choose what risks not to take, but if we choose not to take ALL risks, then that’s when we don’t have any life. I apologize if I didn’t make this phrase clear.

Thanks for the compliment too.


March 31, 2008 at 12:47 pm


I have a response for you, but I have to let my boiling blood calm down first as your entry on your blog and your comments upset me as a CI user.

dog food

March 31, 2008 at 1:01 pm

this is so fascinating… i’m getting an implant soon. hopefully around the summertime.


March 31, 2008 at 1:16 pm

Hi again, yes it is understandable when one makes general statements, it could be interpreted by others as a direct reference to their conditions or lifestyles. That is ok and thanks for clarifying.

As for cochlear implants, to me they are electronic devices akin to other items such as pacemaker (my grandmum and an interpreter both has one.) and others. Sometimes pacemaker do fail (it happened to the interpreter, and she had an surgery to get it replaced.) We do take risks in order to improve our well beings. I think a lot of CI users are informed about that risk and are willing to go through that risk. They rather to take the proactive step and to correct the situation like you did.

We buy electronic equipments all the time without any thoughts about how they would fail in the future, thinking they will be with us forever. But electronic equipments only have a certain lifetime which it can last so long. It makes sense to me that CI devices could fail one day, and to get that replaced with another invasive surgery. Going under the needle can be scary for some people. For informed CI users, I think they are informed about that risk as well and are willing to have that done despite potential failures. If they are ok with that, then I don’t see why they have to be harrassed about that. Some people could argue that for implanting children, then subjecting them to future risks would not be advisable, but it is a “necessary evil” for some people.


March 31, 2008 at 1:23 pm

Rachel, please send me an e mail and we can discuss what is upsetting you. I would feel this way about any medical device, not just cochlear implants.

March 31, 2008 at 2:31 pm

what does a cochlear implant wearer hears?

Kind of funny, tho, with this mis/disinformation.


March 31, 2008 at 3:33 pm

I understand some people’s trepidation about ‘imposing’ CIs on kids, especially since it *does* require lifelong maintenance. However, I will point out that for children, when they grow up, they are not forced to use CIs. I know plenty of young adults/adults who chose not to use it (just not using the external parts). The internal parts are still there, but I figure that device failures won’t affect people who are not using them in the first place. Barring some strange attack of infection/septis late n life, if a person decides not to wear a CI, it shouldn’t have much of an effect on his/her life.

Of course, people argue that it’s an invasion of kids’ bodily privacy. Let me just say, parents invade kids’ bodily privacy allthe time – they consent to surgery, they feed kids whatever they think is appropriate, etc. There has to be some room for informed parental consent for CI surgery. Hopefully doctors and hospitals still do that. I know when my mother agreed to a CI surgery for me, she was fully aware of the risks.

However, if the doctors/hospitals do not inform parents/patients of all of the risks, that’s a problem, but one must blame the doctors/hospitals for that.

White Ghost

March 31, 2008 at 3:58 pm

Mike McConnell,

Ha, ha, ha!

Yes, I saw that…..LOL!

He’s funny but gOOfy! That’s his new nickname. Purrfect example.

That’s true with the misconception.

March 31, 2008 at 4:04 pm

For someone who has invested a large part of her public persona to defending the CI, being upset with Mishkazena is understandable.

Consider the CI an investment of trust in a company. Just as with a pacemaker, if you are going to put your life, your health and future comfort in a company, that company had darned well better live up to it every time! For you to be perhaps the odd person out that suffers is unacceptable, as far as you and your family are concerned. However, in the corporate world, you would be just “a small failure rate”.

Companies that make medical devices should be held to a far higher standard of quality than other manufacturers. The devices themselves should be examined very, very critically and their record, their success/failure rates, and their quality held up to cold reason. Anything less is careless gambling with the precious.

I thank Mishkazena for the harsh light on the industry. It can only make it better for future children and their anxious parents.

March 31, 2008 at 5:40 pm

Before I comment on this, let me state up front that I am a Cochlear Awareness Volunteer. I chose to do this not because I want to promote Cochlear as a company but rather, because being an advocate for CIs is something I’ve done for the past 19 years, and the main goal of this volunteer program is to raise awareness about CIs, and between my two girls we have 4 Nucleus CIs, and so that is obviously the company I would align myself with.

That said, I will say that, over the years, I have seen AB have more than one recall. The initial one came right before Jessica was implanted in 1996. The internal casing of the AB implant, or Clarion as it was called at the time, was made of ceramic, and it wasn’t hardened enough. When little children would fall on their head hitting the implant, the case would shatter. Then, there were two recalls due to moisture, the latest being the Vendor B one. I believe there was one more recall over the years but can’t say for sure.

I think that the AB implant has some great technology, but I would be very angry if I were a parent whose child had a recalled implant in her head. While these companies are businesses, they have a tremendous responsibility to their customers since these are implanted medical devices.

When Rachel was first implanted in 1989, we didn’t have a choice. The Nucleus 22 was all that there was. Similarly, when Jessica was first implanted, we had the option of going with an FDA approved Nucleus 22 off label at age 15 months or waiting until she was two to get her a Clarion (AB) since it was still in clinical trials. We opted for early implantation, which has certainly been tremendously beneficial to her. In neither case did we really have a choice, but, if I had to make the choice now, as someone whose child has experienced two failures, I know that, barring any extreme difference in predicted outcome, I’d go with the most reliable brand.

FYI, for anyone who is interested, here is an unbiased study out of Europe comparing reliability of the brands:

A Multicenter Study of Device Failure in European Cochlear Implant Centers.

Research Articles

Ear & Hearing. 28(2) Supplement:95S-99S, April 2007.
Battmer, Rolf-Dieter; O’Donoghue, Gerard M.; Lenarz, Thomas

Objective: To evaluate the failure rate of cochlear implant systems across a
range of European implant centers.

Study Design: Retrospective review.

Setting: Tertiary care cochlear implant centers in Europe.

Material and Methods: A postal questionnaire was designed to assess the
incidence and mode of total device failure and was sent to 34 European

Results: Twenty seven (79%) centers replied providing data on 12,856 devices
of which 488 (3.79%) had undergone total device failure. Of 8,581 Nucleus
devices (Cochlear, Sydney, Australia), 169 had failed; of 1,761 Advanced
Bionics systems (Advanced Bionics, Sylmar, USA), 123 had failed; of 1987 Med
El devices (Med-El, Innsbruck, Austria), 179 had failed; and of 527 MXM
devices (Laboratoires MXM, Vallauris, France), 17 had failed. Six (22%)
centers never reported failures to competent authorities.

Conclusions: The study suggests that the overall reliability of cochlear
implant systems is satisfactory but that reliability varies considerably
between individual systems. There is a compelling need for agreed
international definitions of failure and for the adoption of uniform
reporting protocols. A common database, independent of the industry, would
offer greater transparency to users and clinics.

(C) 2007 Lippincott Williams & Wilkins, Inc.

If you do the math, the failure rates are as follows:

AB – 7%

Cochlear – 2%

Med El – 9%

MXM (not available in the U.S.) – 3%

Added this a couple of days later – I remember the 4th issue with AB – the positioner, which resulted in a higher incidence of meningitis. As others have said, these problems are likely solved, and AB is likely watching especially carefully after this history, but it will take several incident free years for some of us to believe that their issues are truly resolved once and for all.


March 31, 2008 at 9:05 pm

I agree, everyone has their own limit for how much risk they want to take. It is up to each person. For example, if a toy was recalled due to the risk of lead, I sure as heck would throw it out. If there was a hurricane warning, I sure as heck wouldn’t head to Florida. If the brakes in my car were malfunctioning, I sure as heck wouldn’t drive it. If an amusment park was repeatedly cited for past malfunctions, I sure as heck wouldn’t take my kids there. I certainly wouldn’t expect others to have the same level of risk as I do.

I think that you and Mishkazena have some similar goals. You both want everyone to stop “complaining and avoiding every possible risk,” and “work on striving for improvements and better quality of life.”

Just like you, I’m also amazed by how certain people love to nitpick, make possible ASL risks a major deal and look at them as a half empty glass while the risks are usually avoidable, fixable, and improvable, and teachers, schools, and audiologists who are committed, and committed parents are willing to take every step necessary to protect the health and well being of ASL users. Perhaps we should add ASL users to that bucket?

April 3, 2008 at 5:56 pm

Rachel, I want to say thank you for making it a point to discuss this in your blog. It is very hard for anyone to understand why we don’t get our panties in a bunch over failures because it is a risk that we have to agreed to when we got them. It is unfortunate that it happens.

What some people don’t seem to understand is that they are expecting these devices to be foolproof, absolutely perfect and maybe that will happen in a perfect world. However, some of those seem to forget that these devices are made by humans and humans by no means are perfect and this is not a perfect world.


January 7, 2009 at 11:52 pm

I had my first AB CI in june of 2005. It was not successful after much testing, reprogramming, mapping. I waited another two years and in june of 2007 had an AB reimplantation. Still no difference no success. Completely deaf in that ear and only a little residual hearing with use of hearing aid. Professionals, AV company reps, no one can give me any answers other than possible “soft failure” or some other medical condition might exist to prevent CI from working.


May 4, 2012 at 2:41 pm

My son recently received his second cochlear implant and we were informed that 1% of them fail. It has been almost one year and a couple of nights ago he had to increase the volume,because he said the sound changed. So far it has been fine. However, at this point it is a wait and situation. His first implant was 9 yrs ago and it has always worked perfectly. However, as with all electronics things can change in an instant.