Should Cochlear Americas issue a recall?

11 08 2011

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Cochlear Americas have identified cochlear implants with a faulty Monopolar 2 (MP2) ground electrode presenting an open circuit, in less than 0.3% of devices registered (as of June 2011).

The following document makes recommendations for management of this situation with Nucleus 5: Cochlear Clinical Product Update July 2011

The CI512 cochlear implant from Cochlear Americas was designed with a backup ground electrode for several reasons.  Firstly, in case one fails, the other will still work – this is the redundancy built into the implant.  Secondly, it decreases noise, making NRT recordings more accurate.  Thirdly, it improves battery life.

The electrode that failed (MP2) is the one on the case of the device. That means that the only remaining ground electrode is a wire that comes out of the implant case.  It is the wire that ends in a straight piece in the photo.  If that electrode were to fail, the implant would stop working.

It is surprising that Cochlear is allowing these known defective units to be implanted.

Why isn’t Cochlear issuing a recall?

Why would the decision to implant a device that is tested to be faulty in the operating room be left up to the surgeon?

Why don’t they take them off the shelves and replace them with devices that are grounded properly?

Why allow a patient to have a less than perfect implant that can give them 10% extra impedance issues?

Would you want one of these devices for yourself or your child?

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Recall : Updated in this post.

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79 responses

11 08 2011
Dan Schwartz, Editor, The Hearing Blog

The correct question is, Should Cochlear issue a worldwide recall?

Dan Schwartz,
Editor, The Hearing Blog
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11 08 2011
Howard Samuels

Let’s see. At about 20,000 implants per year, and 0.3% failure rate, that makes (counts on fingers…) 60 failures per year!

Come on, let’s see some corporate responsibility here. Did somebody actually sit around a boardroom table in Australia and decide to keep pumping out the implants, knowing that these devices were going to lose the redundant electrode? Do you think that the ‘normal process of continuous improvement’ got a big push from all those reports of the exact same failure mode in the operating room?

How reliable is that remaining electrode? Cochlear felt that the redundancy was important enough to include the second electrode when the implant was designed. But apparently there are no concerns about long-term reliability with just the wired electrode. Rather than contacting directly to the case of the implant, the wired electrode looks mechanically similar to the intra-cochlear electrodes. And it is quite common for those to be disabled.

As Clint Eastwood said in Dirty Harry ‘You’ve got to ask yourself one question: Do I feel lucky? Well, do ya, punk?’

11 08 2011
Deb

Guess we will wait and see how Cochlear reacts to this news being public. Personally I think they should recall the devices with the faulty grounding electrode…and replace them with perfect devices. That’s what Advanced Bionics does. Yes, it’s expensive and they lose business, but it’s ethical and puts patients first. I would like to give Cochlear the benefit of a doubt in this…so I guess we will just watch and see how they handle it.

11 08 2011
Andy

They should recall any that are not working properly. If it ain’t broke don’t fix it.

11 08 2011
Deafa

It depends if the failure can cause a long time damage or pain.

11 08 2011
pinklam

I don’t think so. If it isn’t affecting hearing performance, hasn’t caused any failures and was just basically performing as an extra backup, I don’t think they should recall the implants. The amount of battery life lost is literally a matter of minutes.I certainly think they should take measures to fix the problem as it appears they are already doing, but issuing a recall would cause more harm to its users than good.

11 08 2011
Allyson Peck

My daughter happens to be this affect. But she is hearing wonderful and doesn’t seem to bother her. The only thing is my doctor never told me about this I have found out 2 years after after we change clinics due to a move. I wonder if they would have told me. Its working fine and I wouldn’t let them replace it!

11 08 2011
Allyson Peck

my daughter happends to be affected by this 🙂

27 12 2015
nicole

why does this make you happy!!!!! my son got implanted 5 years ago and never learned how to talk i was never told that his device was recalled untell his device failed i believe this is the reason my son never learned how to speak because of a device that never was going to work from day one! my son lost 5 years of his life because of this device! my doctor never once mentioned the recall and the fact that his slow to no progress was because of the horrible device sorry but a smiley face is unacceptable for what you child has been throw and i hope for the best for him

11 08 2011
Bruce

Recall it! They have to make it right.

A .3% failure, as Howard pointed out, is about 60 potential failures. That’s even higher than AB’s 2 out of 28,000 failures. It’s significant enough to be pro-active, and show they care, and issue a voluntary recall, before the FDA decides to force one upon them in the USA.

I imagine they feel that being in Australia, means they don’t have to abide by the same rules as an American company did (voluntarily recalling their product, to protect the potential end users) but that doesn’t mean they shouldn’t show they have a caring soul behind the company.

12 08 2011
Howard Samuels

Hi Pinklam,

The document didn’t say that the problem didn’t cause any failures. In fact, the section on ‘Postoperative Clinical Management’ seems to address electrode failures that occur after the patient has been implanted.

The MAUDE database has lots of examples of device failures being explanted because they just stopped working, but the root cause is not given. I wonder if any of those were due to failure of the remaining ground electrode.

Allyson, I’m glad that your daughter is doing well, and hope that her implant is trouble-free for the rest of her life! I wonder if it is the same problem, though. If she’s had her implant at least 2 years, then she has the previous generation implant, right? I’m sure that any company would address any known issues in a product redesign.

12 08 2011
Catherine

Since there doesn’t seem to be any physical injury involved–no harm done to the auditory nerve, I don’t see the need for a recall.

12 08 2011
Howard Samuels

None of the other recalls from AB, Cochlear, or Med-El involved injury or harm, unless you include reimplantation surgery.

19 08 2011
worried

How many other recalls have there been from the other companies?

22 08 2011
Howard Samuels

Hi Worried,

First, don’t be! We’re talking about small numbers here (for any brand). Of course, if anything happens to you, the statistics become meaningless.

As for recalls, Rachel’s comparison chart has one list. It’s no secret that I don’t believe a comparison chart written by a marketing intern for one manufacturer can be even remotely unbiased, but here it is anyway:

http://cochlearimplantonline.com/site/wp-content/uploads/2011/01/Cochlear-Implant-Brand-Comparison-latest-models-only-2.pdf

Med-El had some difficulty introducing a new system in 2004, and the FDA made them fix a pile of things before they allowed it in the US market. I guess it wasn’t officially a recall, because it doesn’t seem like they had distributed devices only to get them back. Here is the letter from the FDA to Med-El:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2004/ucm146926.htm

Back to Rachel’s chart. Look at the list of recalls for AB. In 2002 there was a recall having to do with a meningitis scare. In fact, users of all three implants were experiencing a higher incidence of meningitis than the general population. One of the possible suspects was that a positioner used by AB created some pockets for infection to form. But that didn’t explain the meningitis with the other brands. AB took the safe route and recalled all of their devices until the issue was sorted out. They stopped using the positioner, but the real problem was solved by making the pneumovax vaccine part of the implant regimen. Problem solved. But in the meantime the other two manufacturers kept pumping out implants.

Which should you be worried about more? A company that voluntarily halts production until a problem is solved, or one that keeps selling implants while trying to solve the problem? I sincerely hope that Cochlear figures out how to keep that electrode connected reliably, and soon. But they shouldn’t be shipping devices until that has been resolved.

12 08 2011
Shopping For CI

Is it just me, or isn’t Howard secretly giddy about Cochlear’s problem? He seems to be replying against every post that offered a defense for CA by spitting out rebuttals. Howard is in the HJ forum doing the same thing and he works for AB; a sheep who puts down every argument for CA.

By the way Howard, your previous post implies AB never “harmed” anyone but what about those two documented cases of the HiRes90k shorting, causing pain and burns to the auditory nerve in the cochlea?

I used to have so much respect for you but you’re just another employee from AB who would put down Cochlear Corp any chance you get.

12 08 2011
Admin

Actually, Howard is not an AB employee and he is professional and fair in his observations. A lot of people are very grateful to him for sharing his expertise with us.

11 09 2011
Dan Schwartz, Editor, The Hearing Blog

Howard Samuels should disclose that although he is not an employee of Advanced Bionics, he is a Bionic Ear Association Mentor; and he receives tangible benefits for his work.

That being said, I’ve found him to be a straight shooter in my dealings with him~

11 09 2011
Howard Samuels

Hi Dan,

I did disclose that I am a volunteer mentor – look at the 8/13 post. I suppose you can say that the T-shirt, magnetic name tag, and travel compensation I get for volunteering at a booth are tangible benefits. But I don’t get anything like points to use at the AB store or rewards for any performance metric such as getting people to choose AB. By far the biggest benefit I get is seeing people go through the process of being told hearing aids can no longer help them, and watching them climb out of that pit of despair when they learn about cochlear implants. And then following through with them as they have surgery, get activated, and progress through better and better performance through experience and real upgrades from AB.

11 09 2011
Sam Spritzer

Dan…define tangible benefits in the context of what Howard, myself or any of the BEA mentors receive. I’ll like to see you put your money, or in the case of your comment, your foot where your mouth is.

12 08 2011
Catherine

‘potential’ physical injury involved Don’t want to make CI’s unavailable for Americans because of the presence of the FDA prolonging the pain of a recall.

13 08 2011
Howard Samuels

Hi Shopping,

Any problem with a cochlear implant causes me a lot of angst, knowing how it may affect people who face the same challenges I do.

Just to be clear, I am not and have never been an employee of AB, and I receive no compensation for being a volunteer mentor. Most people are enthusiastic about their cochlear implants, no matter what brand, and for excellent reason. These miracles do more than restore hearing, if that weren’t enough by itself. They enable us to connect with our families, friends, and colleagues. We can participate in life rather than observe it remotely. Doors open to us that were formerly shut. Many of us can use the phone, enjoy music, get a job when we couldn’t before, etc. And due to all of these benefits, some of us enjoy helping others with their decision process when they are shopping for an implant, and share the benefits of our chosen device.

As an electrical mixed-signal design engineer who has been practicing for nearly 30 years, I feel I have about as good an understanding of the technical differences between the devices as anybody who isn’t actually designing them for a living. That level of insight, and my observations of many CI users over the past several years, has led me to want to share what I have learned. And there are people who use each brand who feel the same way, and enjoy helping new candidates (and experienced users) as much as I do. Not all are volunteer and uncompensated, but the core desire to help others is a common thread.

My apologies for one point that wasn’t clear when I said that none of the other recalls harmed anybody. I meant recalls other than the current one. But in the current AB recall, 2 patients were affected. Not to sugar-coat anything, the failure caused ‘excruciating pain’ and ‘possible nerve damage’ but no burns. The nerve damage would have occurred had the patients left the processors on for an extended period of time, while experiencing the pain. Of course, they removed the processors and got in touch with their CI teams. Both of them were successfully reimplanted. Apart from the surgery, which is certainly not to be taken lightly, they were not harmed. A major factor in AB deciding to recall the devices was patients who would not or could not remove the processor if they were to experience pain. Think of babies or people with other challenges in addition to hearing loss.

When the AB implant was off the market (it’s available in all its usual spots except for the US at the moment) I came across several parents of newly-diagnosed deaf babies. Because it is important for babies to start hearing as soon as possible, I advised those parents to choose another brand. And I know audiologists who work for AB who did the same thing. My concern is your welfare. The audiologists at AB have dual concerns – patient welfare, and doing what is best for the company. AB puts patients first, which is why it wasn’t at all surprising to see those employees recommend that babies get an implant sooner from another company rather than later from AB.

When I was first implanted in 2005, there was a problem with one of the companies that made the hermetic seals in the implant. This was known as the ‘Vendor B’ issue. The seals made by Vendor A had no issue. AB’s response was to pull all Vendor B implants from the market immediately, and notify everybody of the issue. I received a letter by Fedex, and was required to confirm with AB that I had received and understood the letter. And my implant wasn’t even affected! The failure mode was that the implant may eventually become intermittent or stop working entirely, but there was no pain or damage to the patient. All of the medical professionals were notified as well, and I’m sure that AB posted the information on the company web site (if somebody can find that post, please help me out here). Contrast that with Cochlear’s response to the current issue.

The reason I have been so vocal about these Cochlear failures is that the company has made several decisions which appear to put profits over patient safety. With about 60 of these failures per year since the implant came out, and possibly the same failure for the previous generation implant (see Allyson’s posts), Cochlear certainly has known about this problem for a while. But they chose to notify only the medical professionals, and even then, the notification came in July of this year. My best guess is that doctors and audiologists noticed this spike in failures, and the questions started coming in, so Cochlear was forced to respond.

Also, Cochlear could have instructed surgeons not to use devices that failed before the surgery was complete. The company left it up to the surgeon’s discretion. Had the company instructed surgeons to return all faulty devices, that by itself would not have been enough, since some of the devices fail after surgery.

What really bothers me is that Cochlear is actively concealing this information from candidates. Even if you feel that a 0.3% failure rate is an acceptable risk to get the brand of your choice, the decision should be made with all of the information. Cochlear could have put a statement on their web site describing the issue and the failure rate. If Cochlear feels that it is a non-issue, then there is nothing to hide, since the candidates would likely agree. You are apparently shopping for an implant right now. You may not be happy about the problem, but aren’t you glad that you have this information? Would you prefer that nobody said anything, and keep you in the dark?

Like Catherine, I don’t want to make CIs unavailable for those who need them. In the US, the FDA seems to be slow to reinstate a product once it has been taken off the market, which is certainly a point of frustration for everybody. But a recall issued by Cochlear would still leave an implant on the market – Med-El. While that would bring the US down to one supplier, one is more than none. There are places such as Australia and NZ that only have access to Cochlear, but that is a government decision. Those countries can certainly choose to include the other brands so as not to put all their eggs in one basket.

If regulatory agencies weren’t involved, and I were choosing an implant today, I would like to be aware of the AB issue (even though it has been resolved) and the Cochlear issue, and be allowed to make my own decision. You may think that the FDA prolongs the pain of a recall, or you may think that the FDA is protecting American citizens. And you may think both of those things! But just because it takes time to reinstate a product after a recall, that doesn’t justify concealing a known failure mode.

Shopping, I’m not looking for your respect, but I do hope that you find my inputs useful in your decision process.

Shame on Cochlear for concealing this problem until the medical professionals discovered it on their own.

Shame on Cochlear for allowing surgeons to make the decision to leave a faulty device in a patient.

Shame on Cochlear for not being forthcoming with candidates and letting them make the decision on their own.

And shame on Cochlear for not issuing a recall.

13 08 2011
Admin

Well said, Howard!

21 11 2011
Dan Schwartz

Howard,

Just to be clear, there were also numerous “Vendor A” failures; however Advanced Bionics will not release the failure rate data… And this came from two separate Engineers who worked for AB until their 2009 restructuring.

That being said, I have received two separate explanations on the issue:
One (former) AB Engineer told me that there was no way to non-destructively test the ceramic feedthroughs, as the microfine cracks don’t even show up under a scanning electron microscope;
However, from testing performed at the now-privatized Reliability Information Analysis Center located at the former Rome Air Defense Center and commissioned by Plaintiffs’ attorneys, they were able to detect defective ceramic feedthroughs by simply dropping them in a glass of water for 24 hours.

[Howard: Since you’re a fellow EE, you probably already know about RIAC and how they have extended MIL SPEC reliability engineering to the private sector.]

13 08 2011
Catherine

I am 99.7% certain (allow me a smile, here) that AB, Med-El, and Cochlear are certain all products are perfect before release. But to err is human and these errors are most likely to be discovered first by the patients using them, then their doctors when the patients report them. After the company is advised by the doctors or patients that there is a problem, the company’s first step would be to find out just what is the problem, and to make sure it is not a surgical error, or patient anomaly, but a discovered flaw in their design of the product. In the meantime, the company would be wise to notify their CI teams and candidates that there is a possible problem and to take whatever precautions they can. I am assuming candidates are demanding guarantees when choosing their device, and the company is hoping never to have to go through the expense of replacing an internal or external device. Because of the guarantees and possible civil lawsuits or criminal prosecution for fraud, the company would then find a solution to the problem, and replace all older products on the shelves with the corrected ones. I am assuming this procedure can still be done, that doing this does not invoke the presence of the FDA. Right now, it looks like because Cochlear did not do as AB did and reveal the problem as it came into light, it probably has set itself up for legal action to be taken against it.

I have said all the above because I would want my company to do its best to circumvent the FDA. I do not expect perfection, which is, I believe, impossible, but I do expect moral responsibility which AB has. And of course I do expect my 99.7% chance of a good implant. Those are really good odds.

And while I am on this subject, is there a legal paper a patient can carry with him when making his decision that all problems have been revealed to him; that he has made his decision in good faith? Such a paper, signed by a representative of the company, and the doctor should have a powerful legal clout.

All I want to do is free up the market from the deadening delays by the FDA. There are other ways to keep producers responsible.

13 08 2011
Dr.V.Ramcharan

Thanks to all for your opinions.
When an implantatuon decision is left “up to surgeons” it means the company has washed its hands of the matter. As far as I know, this means CoA feels the device is perfect. If th Device is not implanted, the hospital still pays for it.

13 08 2011
Howard Samuels

Hi Dr V,

In defense of Cochlear, the sentence

“If you have any questions about the functionality of the implant during surgery, Cochlear will always support your decision.”

means to me that if the surgeon decides not to implant the faulty device, and uses another one off the shelf, then Cochlear won’t charge the hospital for the faulty device. That’s just a guess, though.

13 08 2011
Dr.V

I tried to respond from my Blackberry, but entering a post while my wife was chatting and driving proved too challenging.

As a Surgeon myself – though not in the CI field – I can tell you there are quite a few facets to this thing.

When the manufacturer says “its up to the surgeon” they are saying the implant with a broken ground is working perfectly and does not need to be repaired or replaced. My undersdtanding is : if the surgeon chooses not to implant the device, but implant a different one with both grounds working, the hospital and / or surgeon still have to pay for BOTH devices. Hospitals are run by business managers who have to keep the place financially afloat. Surgery is usually paid for by insurance companies who do not like to pay for two devices if only one is used. Consequences can be loss of hospital privileges and dismissal from an insurance roster. It is not difficult to see how a surgeon could be pressured into implanting a faulty device …especially when they do not have the engineering background to understand the problem.

Many CI surgeons simply do not have the in-depth electronics knowledge to evaluate what the ground fault means. Like many patients, it seems like “ok, well the case ground is gone, but we still have a perfectly good one, so whats the fuss” The matter is compounded when you have a surgeon trained at a CI center that uses primarily ONE brand of implant…and there are many of those. Then the young surgeon gets in practice and joins a group that …you guessed it…uses that same one brand. So they learn to trust the manufacturer’s recommendations.

When the FDA issues device warnings, it is almost routine for them to stress that the manufacturer’s directions be followed, and the written insert supplied with the device be consulted for guidance. So many surgeons will see no ethical issue with implanting a device that the manufacturer says is fine and working as intended.

But there are many experienced and knowledgeable surgeons who understand how CIs work in-depth. That is why I often caution folks to choose an experienced surgeon who works with all CI brands. These are the kind of doctors who feel they are the defense curtain that stands between their patient and death. These are the guys who will do any and every thing to make sure you get the best. They will put themselves at any risk to make sure you get the best. They will not implant a faulty device no matter what the manufacturer, hospital or insurance says. These are the kind of folks who may be challenging the corporate belief that a non-working ground is OK.

How about inplanting a cardiac pacemaker that has one non-functioning ground and the remaining one is historically of the type that is less reliable. Or lets go for a ride in an twin-engined aircraft with one engine not working. Oh, you say the difference is a non-working CI won’t kill anyone?… I just do not get how one can accept that a $50,000 device has 2 power lines, one is not working, and yet it is implanted in a human body as new….with the manufacturer’s blessing. Are you willing to pay full price for your brand new Lexus and find out the manufacturer left out the storage bin for your spare wheel and so you have no spare? Most people would never pay full price for a faulty product even when remedy does not require surgery in the event it goes blink. Auto recalls are commonly based on issues of minor substance.

At the very least, ANY manufacturer of any product that has a non-working part should not sell it as new. They should be willing to repair or replace the product as soon as the fault is found. And immediate steps should be taken to avoid the manufacturing defect in future. I do not care if it is called recall, warranty exchange, upgrade, redesign or whatever. It just needs to be done.

FINALLY, if you or any loved one is scheduled for CI implantation, I recommend a discussion on this occur with the CI team, AND a letter follow. It is vital to put in writing that if ANY part of the system does not work properly and fully including grounding, you will not accept it. That way, you have some assurance you will not have a “second” implanted .

14 08 2011
Dr.V

This has become quite an active discussion!

We all have to make assumptions here because there is not enough information out. And with the history of all players involved, there may never be. I don’t like to post without all the facts, but I do think it is important for prospective recipients of ANY CI to be aware of how they can protect themselves, and that means having some understanding of the background.

Howard may be quite right about the support statement, and I would very much hope so. Its just that I cannot see how a medical device manufacturer can support the scenario where the following happens:
1) a device is implanted in the OR,
2) While the patient is still asleep it is tested for the purpose of ensuring all parts are working properly as is good medical practice.
4) it is found to be missing a ground which the manufacturer finds important enough to specifically design and build into the device.
5) At this point a new device can simply be swapped out as there is a spare in the hospital…and the patient is still asleep.
6) The CI team decides NOT to spend the extra time to swap devices but wakes the patient up because “it still works”

It’s a very different story if the failure occurs weeks or months or years later but it is still working acceptably.

The issue of legal liability is a tricky one. Companies- especially large players with over 0.5 Billion in annual income – have actuaries who can calculate the cost of lost sales from a recall and losses from R&D for re-design vs the cost of legal defense and payment of settlements. I would like to have the world where individual and corporate entities act honorably which would make regulatory intervention needless. But as long as complex financial strategies rule what corporations do, rather than good-neighbor ethics, inefficient government watchdogs are unlikely to disappear.

I am very hopeful that in this case the folks involved will come together and do the right thing on their own.

14 08 2011
MinnMa

Yes, I agree they should be taken off the shelves, but in a situation of a bad ground electrode in a device, there are some very valid reasons why a surgeon may not wish to remove the device during surgery that have nothing whatsoever to do with money. They can’t know there is a problem with the any electrode until after it is implanted and they test the device during surgery. An audiologist tests it usually just after the incision is stitched up. If the patient has a difficult or unusual middle or inner ear anatomy, the surgeon may feel that the risk of removing and re-implanting a new device is too great. For example, this is just pure speculation, but what about a facial nerve that passes through that space in an unusual manner? If the surgeon feels that he or she may risk damage to the facial nerve during the removal and reimplantation process (resulting in permanent paralysis of one side of the face, not being able to close the eye or smile, etc.), then having one of the ground electrodes not function seems far less risky in comparison. This is just purely hypothetical, but my guess is that a decision not remove the implant has more to do with anatomy and/or how difficult the electrode array was to insert in the first place than how much the extra device cost.

11 09 2011
Dan Schwartz, Editor, The Hearing Blog

MinnMa is on the right track when s/he says it’s up to the surgeon whether to explant & reimplant if the CI is not 100% functioning when it is booted up in the OR, usually BEFORE the patient is stitched up: Keep in mind that he has just finished stuffing an inch-long wire into the pea-sized hearing organ; and that pulling out the array and placing a new one involves a certain amount of trauma, and risk to the delicate internal structures.

As I understand it, there are surgeons who will not replace an implant even if it is discovered one of the electrodes themself has failed (as detected on OR boot-up), as they can be steered around (as AB and Med-El have current steering; and have this capability).

15 08 2011
sharoncrouch

Needless to say some of these comments are disturbing. But I think all have a right to give their opinion that’s what’s it all about. usually and Ent goes in with a back up device when doing surgery. 00.03% is a very small percentage and could have happened to any company. The whole point being to those that want to hear make the choice what device they would use. Great that there is a second electrode coil that is why it is called the “Back Up”.
You will never convince me that Cochlear Americas is only in this for the finanicial attributes. I have seen the workings of their company inside and out. There is not another company out there that cares more about their recipents than cochlear. They are always wanting feedback from the recipents to down the road make things better and better for new recipents. The concern is real and heartfelt I stand behind Cochlear Americas 100%! Are there ever device failures of course there are. Cochlear does all (within) their power to make right what they can. Now sometimes they can’t pull a rabbit out of a hat. I think if they could they would Very interesting article. Just remember for anyone to hear is the most important issue here. Whatever decision they make to do is the right decision for them. I am bilateral and I love my CI’s. Here’s to better hearing for all wherever they are and whoever they use. Yes we can hear!!!!! ~SharonC~

16 08 2011
Catherine

I believe it is 0.3%, not 0.03%, a difference by a factor of ten!

15 08 2011
sharoncrouch

Cochlear Americas has been there fro me from the beginning. I seen the workings inside and out and no one cares more than they do. If they could pull a rabbit out of a hat they would. They are always reaching out to their recipents to find ways to improve of furture techonology just as “All” companies do. But not at the rate that CA reaches out and gives back to help further better hearing for all affected. My hat’s off to you Cochlear America. 0003% failure rate is amazing and unbeatable. I am also happy that there are other CI companies that have enabled those who want to to hear again. SharonCrouch

16 08 2011
Catherine

You really need to pay attention to your decimal points, Sharon. I am a Math Tutor and your errors are making me wince. 0003% is read as 3% without any decimal point, and statistically speaking, it is regarded as a significantly high percentage for medical failures. 🙂

20 08 2011
Dr N Vaid

Thank you all of all this information. As a CI surgeon based in India, this was news to me and my team. This will help us in assisting and counselling our patients. This is really important in my country where the costs are borne by the patient and not by the government..so the failure is a 100% for that family and not .03 or .003%.

24 08 2011
Johnny

Just to make a a point about ABs recall not harming anyone at least one of the two is to have the new implant removed even though there is no problem with the device the patient has gotten nothing from it.Maybe this one of 2 out of 28000 is just a very unlucky person and is one of those who do not benefit from a ci although the other ci in the other ear is fine OR was damaged while wearing the faulty implant I do not know but noone can say that noone was harmed for sure.

24 08 2011
Catherine

Johnny, I really want to see the documentation on this. I for one don’t believe it.

24 08 2011
Johnny

Sorry I do not know what part you do not believe.the only fact i have stated is that the reimplanted device is to be explanted again AB have done every test and every programme possible but they know it is not any benefit to the patient .What documentation would you like

24 08 2011
Sam Spritzer

In my opinion, a problem is a problem. It no longer becomes a problem when there is nothing to identify. AB is a very social responsible company. This is one company that puts the best interests of the shareholders NOT first. I am sure it lost a very large amount of money both real and book value. All because of 2 problems out of 28,000.
AB did not sweep it under the carpet like CoA is doing. AB identified an issue, informed the FDA VOLUNTARILY, and invested a tremendous amount of time and money remediating it. Has CofA?
Remember…a problem is A PROBLEM. Now for those of you with CofA implants….do you still want a problem in your head? Do you want a problem put inside your head?
Remember…CofA has not done anything to remediate the situation. All they did was say, “turn down the dial 10%”. So now for those with CofA implants, you have a “10%” problem sitting on top of your brain. I
I, for once, value life a lot more than them.

11 09 2011
Evan

Stay tuned for an announcement regarding the Cochlear Nucleus 5. Apparently that’s not the only problem…

11 09 2011
Evan

It’s official now. All N5’s are coming off the shelf Monday.

11 09 2011
Admin

Hello Evan,

I am sorry to hear of this new worry for intending CI recipients but I am glad that Cochlear Americas seems to be doing something about it. Can we have some verification of your claim? There is nothing on the FDA database on this.

11 09 2011
Evan

It was widely announced today at the AAO conference in San Francisco.
>50 failures with explants reported to the FDA in 2011 so far, and that doesn’t include the last couple months!
It’s shameful and disgraceful business practice to wait this long to do something. How could they wait this long? Seems to me that they were maximizing profits while their main competition was off the market. Where’s the respect for their clients/patients? It should have been pulled many months ago. If it was my daughter, I would look into pursuing a class action law suit. All the failures are documented in the FDA database. Have a look. It’s quite shocking!

11 09 2011
Dan Schwartz, Editor, The Hearing Blog

What is troubling about the ground failure is that the CI512 implants failed QA, but were “passed.”

The alternate scenario is just as troubling: Cochlears’ QA missed the broken ground lead.

In either case, the FDA should be acting to take them off the market until the root cause(s) is (are) located, and fixed.

11 09 2011
Howard Samuels

Hi Evan,

It’s easy enough to find lots of device failures on the FDA MAUDE database. But you have to go through them and discount the ones that were explanted due to medical reasons. I haven’t seen where the FDA publishes the root cause, so we don’t know how many of these are due to problems with the grounding electrode, or due to random failures. It will be interesting to see a public announcement.

11 09 2011
Evan

I have an engineering degree, I’m not a surgeon, but I don’t see how the 50 explants for intermittency and/or failure are medical problems. Sounds like an equipment problem. It’s probably well over 70 by now. And BTW, the grounding electrode problem shouldn’t cause this problem in isolation.
I await the corporate spin doctored announcement.

11 09 2011
Howard Samuels

Hi Evan,

I agree that the failed MP2 electrode won’t cause a total implant failure by itself. It does, however, leave the implant with only the external wired electrode, which *may* be more prone to failure than the already-failed case electrode. Cochlear does have an awful lot of non-medical failures in the MAUDE database, even when you factor out market share and devices explanted outside of the US that probably don’t get reported to the USFDA. I really wonder where the comparison studies on the company web site get their data.

11 09 2011
Dan Schwartz, Editor, The Hearing Blog

The correct answer is to file a FOIA request to the FDA, to see what is going on.

11 09 2011
Howard Samuels

Let’s see what Cochlear has to say, IF there is a recall. AB has been very straightforward with the possible effects of a failure. I hope that all medical device companies would do the same. Call me an optimist.

And I don’t have the patience for the FOIA. By the time anything comes back from the FDA, this will all be old news. One question – do you have to file a request for each of the failures, or can you file one blanket request?

11 09 2011
Dan Schwartz, Editor, The Hearing Blog

I just received this from a CI surgeon attending the AAO-HNS Convention:

You may have already received the general announcement from cochlear but per dr weber there have been about 100 recent hard failures of the nucleus 5 system over last 1.5 years so out of an abundance of caution it is being suspended, and temporarily replaced with freedom.

12 09 2011
Sam Spritzer

And what is the “official word” at the Hearing Blog, Mr. Schwartz?

12 09 2011
Evan

For those that may not understand, a “hard failure” is a device/equipment failure.

11 09 2011
Admin

To add further information – copying over a relevant comment from another post;

https://funnyoldlife.wordpress.com/2011/07/30/all-cochlear-implants-are-not-the-same/#comment-6660

12 09 2011
Admin

Update: Cochlear announces a voluntary recall of unimplanted C1500.
http://www.theage.com.au/business/cochlear-announces-recall-but-cost-unknown-20110912-1k4sr.html

12 09 2011
Donna

Seems really weird – first of all people like Howard and Evan say Cochlear should do a recall and when they do, they are still trying to find fault! Very obvious bias me thinks when they congratulate AB on a ‘voluntary’ recall but not Cochlear?
I think what is being missed here is that any recall is not a good situation for the industry in general and may put people who can benefit from a cochlear implant device off from going through with it. This is the biggest tragedy, irrespective of the company doing the recall.

12 09 2011
Admin

No Donna they are not trying to find fault, they are just trying to explain facts. I agree with you, like Advanced Bionics, it is a tragedy for all those waiting – but it would be an even greater tragedy if cochlear implantations went ahead with faulty implants and nothing was done to stop these being implanted into people’s heads. We are talking about people’s lives here.

12 09 2011
Evan

I also heard that this “voluntary recall” came after the FDA issued a warning letter. It’s not up yet, but they’re often slow to update. Wait a bit and see the truth. This was corporate profiteering at it’s worst. Business was up 20% in the last fiscal year, everyone got their giant bonuses while AB was off the market. Just wait. I realize I’m new to this site, but the facts speak for themselves. AB went off line after 2 reports of a verifiable problem. Cochlear had, by their admission, over 100 failures over 1 1/2 years. The truth was much worse than I suspected, but the conclusion is the same.

12 09 2011
Howard Samuels

Hi Donna,

Please notice in my last post the capitalized ‘IF.’ I was hoping to quiet things down, which were just rumors at the time. My interests are aligned with all of us who have hearing loss and can benefit from cochlear implants. And of course, I like to promote the technical benefits of AB. But I don’t have a vendetta against other implant manufacturers. I’ve recommended that parents of newly-diagnosed babies choose another brand rather than wait for AB to come back when AB was not available.

So I completely agree that not having an implant available, especially for children, is a tragedy. But there are two other implant companies in most markets. so that doesn’t have to happen.

Selling devices to be implanted that are known to have a problem is a far greater tragedy. So far 100 people have had device failures due to the delayed response, and there is no word yet on how many more people who have the CI512 implant that came with the N5 can expect this failure. Cochlear is investigating this, and hopefully they will have some information which will be comforting to current N5 users soon.

It is fortunate for Cochlear that they are still producing the N24 for some markets. This will make it easier for the company to substitute the older implant in many cases. And Cochlear says that it is fully compatible with the N5, but it doesn’t say whether the N5 implant had any performance improvements over the previous generation.

I’m very curious about the root cause of the failures. If the problem were the known MP2 failure issue, then nearly every single device with an MP2 failure would have had to had the second ground electrode fail to total 100 incidents. That seems pretty unlikely, which would mean that there may be another mechanism at work here. I won’t speculate further, because Cochlear is investigating the problem. But I do hope that Cochlear contacts all of the current users to inform them. Only a small fraction of implant users visit these forums and blogs. AB contacted all users, and required that we acknowledge receipt of the notification.

Do you know the chart on Cochlear’s home page (click on the reliability link) that shows how each generation is more reliable than the previous generation? It had a special blown-up section because you couldn’t see the failure rate for the N5 – it was too low on the scale of the chart. Now that Cochlear is asking people to take the previous generation implant – poof! The comparison chart is gone. What are the ethics here? Naturally, anybody being told to take the previous generation implant would go to the web site and look for the differences. But the information is being obscured intentionally.

12 09 2011
Admin

For any further updates on this issue (and the comparison chart Howard mentions), please see the new post https://funnyoldlife.wordpress.com/2011/09/12/cochlear-americas-issues-a-recall/

20 09 2011
Pam

I am literally sickened by everything I’ve just learned today.

My Cochlear device (Nucleus 5) was implanted May 4th and “turned on” May 31st. By July 26th I began experiencing intermittent failures and by August 19th the implant was pronounced “defective” by Cochlear’s Audiologist and their Engineers in Colorado that analyzed the test results. It was shortly after this that my implant failed completely.

On August 31st I had the explant surgery and was re-implanted with another Nucleus 5 device. I was led to believe that Cochlear had determined the root cause of the problem and that I would be certain to have a “good” one re-implanted — this was conveyed to me by Cochlear’s Audiologist.

My Audiologist contacted me today to advise me of the recall and said we could discuss it in more detail three days from now when I’m scheduled for my initial stimulization of the device.

Curiosity had me researching to learn more about the recall and found I would have had the ‘Freedom’ re-implanted if the surgery would have been after the recall annoucement. I missed it by less than two weeks due to Cochlear’s delinquency in issuing the recall and announcing that the Freedom would be the replacement implant. At this point I have very little confidence that I won’t be experiencing the same problems in 2-3 months with this Nucleus 5 as Cochlear chose to continue manufacturing and shipping a product they knew had potential problems and with the root cause yet to be identified.

Intuitively I know the odds are in my favor that I won’t experience a second failure, but try convincing me of this emotionally when I’m still recovering from the surgery trauma and the pain still very fresh in my mind.

26 09 2011
Coach

Unfortunately my N5 that was implanted in April 2011 has failed. As you can imagine this is very difficult to deal with for me and my family. Both the Company rep and the surgeon are recommending I have the freedom implanted ASAP. I feel a bit rushed but at the same time want to move forward. I did a basic search and came across this site and find it interesting how long this problem has seemed to have been around. It is very hard to believe that I must go through surgery and recovery again if I choose to do so. Thanks for any advise and I really don’t want to get into talking too negative about ANY company as they have all had their share of problems.

26 09 2011
Tina

Hello Coach
I’m very sorry to hear of your situation. I understand they would want you functioning again fully ASAP so yes, it makes sense you’ll get rushed through. I would think recovery would be much quicker 2nd time around, (saying this from experience of a 2nd implant, not re-implantation) as your brain already knows CI sound. It’s unlikely you’ll have problems with a replacement. Do check the other thread on this subject for latest updates. I wish you the best.

9 11 2011
Rhonda Clancey

I also was implanted April 2011 and my device has failed. I am absolutely pissed with the Cochlear Company. They also want to re-implant immediately. I have had 8 months of misery. I had 6 months of vertigo. Now ,financially drained after 17 visits to the implant clinic. I want total payment of hospital, surgery, follow-up visits, lost wage, transportation back and forth!!! Will I be reimbursed??

9 11 2011
Howard Samuels

Coach and Rhonda,

I’m sorry to hear that your implants have failed. Most likely it is not the same problem discussed here. This is an electrode problem, while the recall has to do with a loss of hermeticity.

Coach, if you do choose to reimplant with the CI512 device (the previous generation) the shape isn’t exactly the same. My guess is that it would be less traumatic than your first implant, but not quite as easy as if they were replacing the implant with an identical device.

Rhonda, the vertigo is a common side effect of implant surgery (or any ear surgery, for that matter). Hopefully yours will resolve itself soon. But I don’t think that the vertigo is related to your implant failure.

10 11 2011
Rhonda Clancey

Thank you for replying. I am aware that vertigo goes along with any ear surgery. My failure is due to the recall. The diagnosis was made last Friday, Nov 4. Cochlear has already sent me the implant replacement surgery process papers plus their care coordinator has contacted me by phone. She wants me to give her the ball park figure for my lost wages + mileage. I expect reimbursement for my insurance copays + deductibles. How do I know I am getting reimbursed for the amount I am illegible? What about the pain and suffering? I made 17 trips to my implant clinic since the implant. I need to be advised please.

10 11 2011
Coach

Rhonda, I had the re-implantation surgery a few weeks ago and so far Cochlear has only offered to cover the “out of pock” expenses’. They are not willing to pay for my lost wages or anything else. I could not even get them to extend the warranty on the processor, I was only able to use it for a few months. They basically are willing to cover co-pays and what the insurance won’t cover due to surgery. They did offer me a small amount of money (few hundred dollars) if I would sign a release form.
The more I talked to them the more frustrated I got. So I am seeking legal advice before I communicate with them again. I hated going thru the whole thing again, but I want to hear! I am upset with the whole situation and the time it has taken out of my life. The second surgery was different from the first, some ways easier and some ways harder.
Not sure if you have heard but they are saying it was a moisture problem that has caused the implant to shut down.
Good Luck,
Coach

10 11 2011
Dan Schwartz, Editor, The Hearing Blog

Coach, I suggest you contact CI litigation specialist Teresa Curtin, Esquire (who herself has a CI) at Weitz & Luxenberg in Manhattan: She has handled over a hundred cases involving defective implants, the vast bulk of them failed AB HiRes 90k.

Weitz & Luxenberg P.C.
700 Broadway
New York, New York 10003
212-558-5907
646-350-2426 (videophone)
212-344-5461 (fax)

That being said, collecting damages is difficult, as any claim in State Court is explicitely barred by the 8-1 Riegel vs Medtronic decision. Basically, it means that since the FDA approved the device, it’s assumed to be safe and effective, and pretty much immune to lawsuits. My recommendation is to talk to Teresa, as you may still have a claim for incidental &/or consequental damages under the Magnuson-Moss Warranty Act of 1975, part of Title 15 of the United States Code (15 U.S.C. § 2301 et seq.).

Dan Schwartz,
Editor, The Hearing Blog
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10 11 2011
Dan Schwartz, Editor, The Hearing Blog

E-mail for Teresa Curtin: tcurtin@weitzlux.com
[The mailto: html link got swallowed]

18 11 2011
Rhonda Clancey

Coach, I wanted you to know that I had talked with Cochlear Care Coordinator 1 week ago and had not got a response. I called today and her attitude was 180 degree turn. She told me I have to go ahead and have the surgery and then they would negotiate terms for reimbursement for travel and missed work. I had sent them paper work for 18 trips at 200 miles each and all the missed wages for the failed implant. 1 week ago she told me I could request either the past year or the new year..now I can’t. I can’t help but hear your words!! Any advice from anyone?

21 11 2011
Howard Samuels

Wow, you would think that Cochlear would be bending over backwards to help people who have had their implant fail.

Coach, I wouldn’t sign a release form without talking to a lawyer. Rhonda, if you have reimplantation surgery, how comfortable are you that you will be reimbursed for your expenses afterwards?

22 11 2011
Rhonda Clancey

Thanks for responding Howard Samuels! I feel helpless. Unfortunately, I have feel very skeptical with getting reimbursement of my expenses after my last conversation with the Care Coordinator. My first conversation was pleasant. I was to figure all my expenses and submit. I followed these instructions. One week later I felt I was talking to a different person. The Care Coordinator told me I had to have the surgery first and then they would decide if I could get any reimbursement for missed wages and travel. This was no guarantee. She became very defensive and I had to ask her to calm down. I told her because of my hearing loss I needed to repeat so I could confirm what I was hearing. I once again told her I needed confirmation that my insurance out of pocket would be paid. I told her the generic letter she sent me stated “I maybe eligible to receive” copays and deductibles. She said she would write me a new letter (which I am waiting to receive).

22 11 2011
Dan Schwartz

@Rhonda: Two pieces of advice for you. One, when calling Cochlear Americas, use text relay instead of voice and save each conversation, so that you have a written transcript of everything said. I use i711.com for when I need a conversation saved: It’s free, easy, and it provides you a layer of protection. [For a tutorial please see http://TinyURL.com/Relay4Free ]

In addition, my other advice to you is the same as it was to Coach — Contact an attorney. You can hire a local MedMal specialist; or a CI litigation specialist such as Teresa Curtin (scroll up for contact info). At that point, your attorney will handle all communications with Cochlear.

Dan Schwartz,
Editor, The Hearing Blog
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22 11 2011
Coach

To update: As far as I can tell Cochlear has held up to covering the surgery and hospital/Dr. bills. Not sure if that will change or not but, for now, everything seems to be paid for. My Dr. office and hospital is sending them the bills directly, I believe.

As far as getting other cost (time off) covered, they don’t seem to be willing to pay for that. I have talked to my lawyer and I am still going over my options on how to handle everything.

Rhonda please keep us posted and if anything changes on my end i will let you know as well. Some advice I did get was not to communicate too much with them until I decided how to handle the situation.

On another note, i am pretty excited/ nervous as my A-Day is near and I’m hoping for the best.

Coach

7 03 2012
mireille

I am from belgium my son his ci 512 is now defect.He has a implant from 20 june
and it has stopped working 10 december now 6 march he hasnt a new implant the reason he is afraid for a new implant he is 7 years old.
My question is we made serveral cost fitting ,hospital cost,km cost etz.
can we ask cochelar to pay these cost ?Is it adviced to lawsuit agaist cochlear? this cost are about 6000 euro.

16 07 2012
Honore Pittenger

I am sick when reading many of these. @Rhonda …..I have had the same experience for my son with the Care Coordinator. My son is 7, two years ago I said that he was not hearing as well, not terrible but there was a change. We re-mapped, etc..etc… Then cochlear began doing integrity testing. I knew by the amount of times they did it there were problems. Slowly his hearing was decreasing. We went over 8 hours away to a place I had heard good things about. (this was in June 2011) They said it possibly was a failure. I was very upset with our center, only to find out that they were told about these issues the same time we were. Cochlear flew an engineer who told us all about their new device and how great it was and we should do it (the re implant) right away if we were ready. I drug my feet because I felt they were not telling me everything. I quit talking to them via phone and only would use email. Two weeks later that device was recalled. In March of this year one of his was re-implanted. He has to have the second done in August (it is failing also and really getting worse). I am scared that there will be more info that will come out but at the same time he needs to have the re-implant done. Cochlear said they would pay for what the insurance did not cover. I argued with them that they should not even be billing my insurance. I have gone round and round with them at this point. I did ask in June of 2011 how they would let their recipients know and their pathetic answer was only through the centers (my take was only if there was a problem). My answer was that if I would not have been persistant no one would have ever told me but I stayed on them for a long period of time as it slowly got worse. This has been a hard road for our family and my son. I did just contact the attorney’s listed on here today. I had no idea how to get with any group until this.

17 07 2012
Tina

Honore, I am so sorry to read about your and your son’s experience with the device failure. What an awful thing to go through. Hopefully this will be resolved to your satisfaction in the near future.

17 07 2012
cem4881

It is always tough to listen to stories like this. I do hope you can resolve all your issues, that your son can get on with it.

17 07 2012
Coach

I am sorry to hear that your son is having to go through this. Having a CI failure myself was a very tough situation that I would not wish on anyone. The only positive light I can give you is that my new (re-implanted) CI is working Very well.

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