Failing Ugly II: More on the Advanced Bionics Recall


UPDATE #3 (1 August 2011): Vindicated! Our friend Tina in London has just published Why 2 Advanced Bionics HiRes 90K cochlear implants failed, including the source document (PDF) sent to the Malaysian Ministry of Health, Medical Device Control Division, confirming the failure resulted in a dangerous DC bias condition. The fact that Advanced Bionics significantly misrepresented to the Malaysian Health Ministry the damage occurring from the electroplating effect caused by DC bias conditions — Which involves the “ripping off of the metallic crystals from the electrode contacts, destroying it (them) over time… And leading to consequent damage in the tight spaces of the cochlea, as such electro-chemical reactions can produce bio-toxic byproducts, as well as introducing potentially damaging changes in the local pH,” and which is independent of any painful overstimulation and can occur silently — is in and by itself a matter for further investigation by the FDA and other regulatory authorities for the misleading statement to the Malaysian government.

Original document: Advanced Bionics report to the Malaysian Ministry of Health, Medical Device Control Division (click to open PDF in a new window).

 

UPDATE #2 (19  Feb. 2011): Please see the comment by “Mary” about the working conditions at AB.

UPDATE #1 (7 Jan. 2011): Please see the update on the lack of implant burn-in in the first article in this series Failing Ugly: Advanced Bionics cochlear implant circuit goes haywire


We at The Hearing Blog have received more information on the so-called “voluntary” recall of the Advanced Bionics HiRes 90k cochlear implant, making us stand up and take notice. If you haven’t read the first article in this series, please click on Failing Ugly: Advanced Bionics cochlear implant circuit goes haywire.

The first item is pretty mundane, and confirms what we published previously: A scan of the patient recall letter, signed by Gerhard Roehrlein, PhD, CTO & Interim CEO (click to enlarge):

Advanced Bionics US Recall Letter sent 11-29-2010

Advanced Bionics US Recall Letter sent 11-29-2010


The second item gives us pause: The five page PDF (click here for entire PDF file) sent to European and UK CI centres from their Rixheim office, signed by Michael E. Sundler, Senior Vice President. Several things in this communications jumped out at us. First was this paragraph at the bottom of the first page, which shows this recall was anything but “voluntary:”

If our records showed that you have any unregistered implants in your possession, a list of serial numbers was provided for devices that must [emphasis added] be returned to Advanced Bionics.

Second, the troubleshooting advice is unsettling, for reasons to be discussed:

1. Identified recipient is reporting/showing signs of extreme pain with their typical program:

a. Exchange all external equipment.

b. Create a program with all M’s set to 0.

c. Try the ‘zero’ M program.

d. If the recipient hears nothing/does not demonstrate an adverse reaction, they do not have the issue. Discontinue use of the ‘zero’ M program.

e. If they experience extreme pain or demonstrate an extreme adverse reaction with this program, discontinue use of the sound processor. It is likely that they have an implant with this issue.

f. Contact your AB Clinical Specialist or Technical Service Europe.

The rest of the letter just outlines scenarios where the user currently didn’t have symptoms, and also if implanted within the last two years; and then an acknowledgement letter to be signed & returned.

What jumped off the page at us was that, in combination with the posting below for the young child, the M levels (upper levels of stimulation) can be set all the way to zero and the problem(s) still manifests itself.

Put another way, if the M levels were set to an arbitrary level far below the T levels (threshold limits), i.e. the upper limit M levels were set to 5% of the threshold and overstimulation occured, that would point the finger at a failed voltage regulator module (VRM) on the implant circuit, as this would imply AC signals crossing the output capacitors. However, with no input (as stated with the M levels set to zero) we still have an overstimulation condition, this would imply a failed short output capacitor, leading to the electroplating effect: This involves the ripping off of the metallic crystals from the electrode contacts, destroying it (them) over time… And leading to consequent damage in the tight spaces of the cochlea, as such electro-chemical reactions can produce bio-toxic byproducts, as well as introducing potentially damaging changes in the local pH.


The the third and most distressing is this post on Tina Lannin’s influential CI Blog about the recall:

Firstly i have never posted on this site before and have only just found it after trying to find more information on recent events.

I do know however some of the information on one of the confirmed cases relating to the recent recall and although i do not know or understand any of the technical details i do know of some of the time frame leading up to this.

Bilateral implant surgery on the case that i know of was in April 09. Problems occured shortly after activation on one side. Company and audiologists tried various ways to fix problem but recipient was unable to wear device for integrity testing. Eventually integrity test was carried out under general anaesthetic in Nov 09 and device was explanted in Jan10. So AB have had faulty device since then to investigate. Confirmation of device fault came 2 weeks before AB made their recall press release.

Like i said this is only one of the confirmed cases. The company where not very forthcoming in admiting this case was related to press release but after reading the description of problems recipient experienced and the timing of device fault notification they eventually confirmed this.

Original implant that was not removed and showed no fault is working well as is the second implant recieved in Jan 10 but not at the same level.

This is troubling on several levels:

  • First off, although very few adults get simultaneous implants, it is common among infants and young children;
  • Second, it shows how yong children cannot report back if they have a problem;
  • Third, something is pretty far amiss with the CI audiologist when s/he has to perform a sedated integrity check under general anesthetic. We can accept that if this was the only CI; but obviously the child is successfully using the other implant… In other words, the implant so badly Failed Ugly, the child could not even stand to have it turned on;;
  • Fourth, the bad implant was built prior to April 2009, which sets in motion a whole new set of questions consisting of what did they (Advanced Bionics & Sonova) know, and when did they know it?

The first three questions not only go back to the competency of the AB technician, but also to the CI audiologist at that particular center; and also to the surgeon, who is “captain of his ship.”

The fourth question goes back to how much Advanced Bionics disclosed to Sonova’s auditors when they were at their HQ in the second week of June 2009 when they were performing their Due Diligence. Given that Sonova Holding (SOON.VX) is a publicly traded company, and given how their shares have tumbled since the recall was announced two weeks ago, one has to be suspicious.

Along these same lines, how much did the Advanced Bionics division of Sonova Holdings AG disclose to FDA regulators? To the UK and EU regulators (for their CE marque)? To the Zurich stock exchange to meet their disclosure rules?

We here at The Hearing Blog have not received any return contact from Advanced Bionics. There are many thousands of people out there that have AB HiRes 90k implants in their head, in their young children’s head, have surgery dates, or are in a holding pattern, waiting for answers~

Short URL for this article: http://tinyurl.com/FailUgly2

Comment problems:

It’s been brought to our attention from several of our readers that they were having their comments rejected by the Akismet plug-in for WordPress as spam. This is unacceptable to us; and we are soliciting suggestions for a replacement. Unfortunately, we have to use something to screen for spam, as we were receiving over 100 spam comments per day at its’ peak. In the interim, to save retyping, we recommend selecting & copying all of your text to the clipboard: If your comment is accidentally rejected, simply paste it into an e-mail message, put “Rejected Comment” in the subject line, and send it to us at Dan@Snip.Net and we’ll manually post it for you~

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About the author

Dan Schwartz

Electrical Engineer, via Georgia Tech

15 Comments

  1. Jeffrey
    January 6, 2011 at 7:38 pm

    I’m perplexed by a claim in your post. Where exactly is the evidence that AB didn’t voluntarily issue the recall? All that the paragraph in question states is that the company is asking clinics to send the recalled model back to the manufacturer. I could certainly be mistaken, because I often am, but I don’t think that “voluntary recall” means that it’s up to the clinics whether or not they want to return the devices or not. I would interpret “voluntary recall” as meaning that the manufacturer decided to issue the recall without necessarily being compelled by another agency at that particular time.


  2. Jeffrey
    January 6, 2011 at 8:00 pm

    The comment I made earlier doesn’t seem to be here, so I’ll reprise.

    “Wow…You should change the name of this from ‘The Hearing Blog’ to ‘The Wild- Speculation-and-Thinly-Veiled-Accusations-Based-on-Assumptions-and-Incomplete-Knowledge-of-the-Facts Blog'”

    That would definitely be more representative.


    • Supervisor
      January 6, 2011 at 9:00 pm

      To answer your question, AB’s recall was “voluntary” in name only, one step ahead of the FDA demanding it. Evidence of this is the FDA-ordered shutdown of the HR90k production line until the problem can be resolved to the satisfaction of the FDA. They have .NOT. received approval from the FDA to restart as of today.

      Furthermore, since you may have missed it, here is the actual 5 page PDF recall letter from Rixheim to CI centers not in the Americas. Notice it includes specific instructions to clinicians on how to diagnose the problem by setting all M levels to zero. Also note my follow-up analysis of that specific instruction.

      In addition, I have received input from yet another former longtime AB Electrical Engineer who read it, and said I was spot-on.

      Finally, there is a third article already in the works with new facts I have uncovered which I’ll be publishing in about 10 days; however one revelation was such a complete stunner, I will be adding it to this article as an update in red.

      [By the way, because of the 50 or so spam comments I get every day, I usually go through them once or twice daily — I need to add in a Captcha or something similar to the template to stop the bots. I pay to host this website; and it has No Ads.]


  3. Jeffrey
    January 11, 2011 at 8:23 pm

    At the time I previously read your blog, I didn’t really have the window of time I needed in order to comment on everything I felt was deserving of it. I have an evening with nothing pressing, though, so I feel compelled to now put in my two cents. I want to start by inquiring about your amount of experience as a clinical cochlear implant audiologist. I’m genuinely curious, and my question is prompted by your assertion that something must have been “pretty far amiss with the CI audiologist” because an integrity test was done under anesthesia on the child in question (or at least it was done that way according to an unverified, uncorroborated comment by someone with unknown credentials. Although I didn’t go to law school, I wonder if that would be categorized as hearsay…but that’s a matter for another posting). I’ll share an experience we had with a child in our implant clinic. It involved a pre-lingually deafened young child with some marked behavioral issues who was sequentially implanted with devices from a manufacturer other than Advanced Bionics. This child used the first side device for several months with no significant problems. However, at the time of initial activation of the second side implant, the child absolutely refused to keep the speech processor on the head. This behavior continued over the next several weeks, and attempts to get the child to wear the processor were met with screaming, kicking, and thrashing about on the floor. Nothing like this had been experienced with the first implant. If we had chosen to pursue an integrity test at the time, the child would either have needed to be sedated or in a state of relatively deep sleep, I would contend. Otherwise, there was no way that the implant could be kept in place long enough to complete the testing. I suppose we could have drawn the conclusion–without confirming a device malfunction–that the signal from the implant was so unpleasant that this child couldn’t stand it and consequently proceeded with explantation. Had we done so, however, a completely unnecessary surgery would have been conducted and a normally functioning implant would have been removed from the child. We proceeded on the assumption that the issue was behavioral and that we could play a waiting game with the child that we would eventually win…and we eventually did. The child is now successfully using bilateral implants with no issues. If, on the other hand, we had determined that we needed a definitive answer earlier on regarding whether or not there was a problem with the internal device, some type of sedation would probably have been considered…Perhaps not general anesthesia (if, in fact, that was what was truly used on the child discussed above)…but some type of sedation nevertheless. If we’ve seen a case like this…as well as some others that have some similarities to it…I wonder how many other experienced CI audiologists have had experiences with children along the same lines? Other than the comment someone left on Tina Lannin’s blog, what do you know about the child in question? Was s/he normally developing or were there signficant developmental delays? Were there concerns for behavioral issues? Exactly how old was this child? What were expressive communication skills like?
    Before I close, I want to address the fourth point you made above:

    “Fourth, the bad implant was built prior to April 2009, which sets in motion a whole new set of questions consisting of what did they (Advanced Bionics & Sonova) know, and when did they know it?”

    When I read that, I interpret the implication that AB has been aware of some catastrophic and perhaps widespread problem for some time and that there has been a nefarious conspiracy to cover it up and, by extension, place additional recipients at risk. For the sake of arguement, let’s assume that they did know back in January of 2010 that they had a confirmed case of DC leakage in one internal device. Should they have immediately issued a recall at that point based on a failure mode identified in .00003% of the HR90K devices implanted? DC leakage is a serious problem, so perhaps one could argue that they should have. On the other hand, what was the mechanism that was causing the failure mode? What might have caused the mechanism to exist in the first place? Was this cause isolated to devices manufactured within a certain lot or batch or time frame? Was there any reason to believe that there were additional patients with the same failure, and, if so, how many? I can’t imagine that any of these questions could be answered overnight. On the contrary, AB ended up hiring an independent research firm to help them answer these questions. (something that, by the way, hasn’t been pointed out in any of your posts or in the comments of others).

    While failure of implantable cochlear stimulators isn’t common, there are a fair number of them every year. I can’t help but wonder how often the technicians/engineers doing the bench testing on the explanted devices run across a failure mode that they haven’t see before. Should an immediate disclosure be made to all the recipients of that particular model of device and a recall be issued each time this happens…before the issue is understood and all the facts and details are gathered? I suspect that would cause a fair amount of unnecessary worry among recipients as well quite a number of recalls across all the implant manufacturers

    If you really want your blog to be something akin to Consumer Reports, it might be worthwhile to have the background and the facts researched, delineated, and verified before resorting to innuendo. It’ll make you much more credible.


    • Supervisor
      January 18, 2011 at 3:21 am

      Jeffrey: You raise a valid point about the integrity test, in which the full suite takes two hours to complete. The duration I was not aware of until several days ago, when one of my sources who may have an early failure after just several hundred hours had theirs.

      Your other contention where you quote me as saying,

      “Fourth, the bad implant was built prior to April 2009, which sets in motion a whole new set of questions consisting of what did they (Advanced Bionics & Sonova) know, and when did they know it?”

      I will not answer at this time, as doing so in full would compromise two of my sources. Since I published this second article in early December, new details on the timeline have emerged, which have confirmed the veracity of my sources.

      Finally, one week ago another longtime former AB engineer stepped forward and contacted me to confirm that the failure mechanism is a “strong possibility.”

      Keep in mind, I take No Joy in publishing these articles, as I have met many dozens of successful AB CI users, mostly through HLAA but also at the local A/V schools: You would think that MedEl and Cochlear would be dancing in the street from the extra business; but in fact they are quite pissed off too, as this is making the entire CI industry — You (Jeffrey) included — look bad~


  4. Jeffrey
    January 19, 2011 at 8:01 pm

    Time may prove me wrong, but I can’t help but feel that a number of your posts have a tendency toward over-generalization or hyperbole. No representatives with whom I interact from the other implant manufacturers have made any remarks regarding their reaction to the current situation other than to say we should let them know if they can provide us with additional devices for surgery. One might argue that they are being professional and exercising good etiquette. Perhaps so, but that would definitely be a first, because in the past my experience has been that they’ve been willing to point out AB’s problems or perceived errors with alacrity. My current perspective on the MedEl and Cochlear is not an insider’s one, however, so maybe they are quite…aggravated.

    I would also disagree with you that anyone is making me look bad. I’ve discussed the recall–and shared the information from AB that is pertinent to it–with quite a number of CI recipients and/or their families. Although most of them exhibited some initial concern, after answering questions based on my information and going over the matter in a rational way to their satisfaction, no one has yet expressed anger, feelings of betrayal, disgust, etc. towards Advanced Bionics or towards me.

    This could certainly change in an instant, but I would contend that the fact still remains that there are only .007% of the HR90k devices that have been confirmed with this DC leakage failure mode. Are we going to see a relative avalanche of recipients who ultimately have this problem? The undertone or the message I perceive to be between the lines in your posts is that such a rash of failures is hovering on the horizon waiting to be discovered. But if so, why haven’t there been additional confirmed cases now that every clinic in the world knows what to look for in terms of symptoms?

    You stated that you know dozens of successful AB users. I myself know hundreds, yet the focus in your posts is on a failure mode present in two of thousands of successful AB users. You’ve mentioned at least twice that you take no joy in publishing these articles, but then it seems you spared no pause in posting the news of AB’s lay-offs (with numbers that your source had apparently inflated). I’m not surprised that there were layoffs. The company has a number of people closely involved in marketing, manufacturing, and selling new cochlear implants, but they suddenly can’t sell any new devices for a few months. I didn’t go to a fancy economics school, but I’d guess that a sudden interruption in one’s main source of revenue would bring about the need to reduce costs–including payroll–until revenue is restored. What, however, does that have to do with what technology issue or problem is at the root of the current recall or what’s being done to correct it?

    You, and only you, know your motives for publishing these articles. People have a right to know the truth and the facts, especially when it comes to medicine and medical devices. Perhaps you believe you are uncovering a great wrong, and perhaps that will be revealed in the passage of time. To me, however, when I read much of what has been written, it smacks of alarmism at best and schadenfreude at worst.


  5. Hearing Aids
    January 20, 2011 at 5:07 am

    I really appreciate your post and you explain each and every point very well.Thanks for sharing this information.And I’ll love to read your next post too.


  6. Bill
    February 11, 2011 at 5:58 pm

    Great discussion, Jeffrey. Not so great, Hearing Blog.
    I have an AB implant and I’m getting a bi lateral implant in a few weeks so I wanted to know about the problems AB is experiencing. This was certainly not the web site to look.


    • Supervisor
      February 12, 2011 at 8:55 pm

      Bill, you’ll be waiting until at least Memorial Day, as AB’s implant production line has been shut down by the FDA.
      Are you getting a MedEl Sonata Ti100, a Nucleus 5; or are you going to wait until summer? Also, you do .NOT. want to be the first one your surgeon implants after the shutdown, especially if you’re getting the Helix (perimodional placement) electrode.


  7. Mary
    February 17, 2011 at 2:08 am

    A bit off the subject, Advanced Bionics has always presented a very rosy picture of an important, progressive business. They appear to be the ‘Industry standard’ for impaired hearing solutions, very successful and pay their employees well with great benefits. I can’t speak about details regarding the CI recall but I know something about internal politics. I am a woman working as an administrative assistant in Regulatory Affairs & Strategic Reimbursements. For three years I have performed Spanish translation and data management for AB material sent to the FDA and other international health and welfare agencies. I have heard some disturbing complaints and allegations regarding AB products. I have read emails from frustrated, angry vendors and been privy to grievances between engineering and sales colleagues.

    I’m not a disgruntled employee, but since Sonova acquired AB, the atmosphere has changed, its become more corporate, micro-managed and superficial. Now, after the recall, the work environment is more stressful and demanding, with many people concerned about their jobs and avoiding scrutiny. There is a lot of backbiting and vicious behavior on the part of many co-workers and staff, Including incidents of sexual harassment and disrespectful remarks by arrogant engineers and junior execs. I have not complained or taken action so as to keep my job, but lately It has become a toxic work environment. My hours have been reduced and I expect that layoffs may affect me soon. It’s very sad, when I started working here, it was a promising, exciting place, much happier and rewarding. If I manage to stay employed, I fear it will be a long, uphill climb back to a comfortable and satisfying workplace. Perhaps others feel the way I do, but there are few public forums for AB employees to speak honestly about their jobs.


  8. Sheri Birnbaum
    June 12, 2013 at 4:31 pm

    I’m a confused consumer trying to make the right choice for an implant and the recalls are genuinely concerning. Fortunately, I have some months to figure this out since my cochlear implant requires a pre-surgery then the implant.

    The marketing (and it is marketing) material from AB can be ignored. The consistent problem in the States is getting accurate information. A friend called and mentioned the recall. It, of course, was blown off by comparing recalls in other companies.

    Unfortunately, in a comparison chart (non-AB but I don’t know who paid for it) AB specs (real or imagined) blows other competitors away. I’m deaf. I want to hear at the highest dB level and across the board frequencies. Hearing music may be a pipe dream but with the specs listed, it would be possible.

    So, now the question is … Due to the number of lawsuits in such a short period of time, do I look at the other hokey stats from other hokey American hedonistic companies? Sorry, they’re all bad. Which is the best choice… (I’m obviously not a kid or close to being one.)


    • Dan Schwartz
      June 13, 2013 at 9:38 am

      Sheri, there are several parts to my answer; but to start out, the CI surgeon you choose will make all the difference, as it takes special skill to thread the inch-long electrode into your pea-sized cochleas. Since you’re in the Asheville North Carolina area, you’ll need to drive 300 miles west to Robert Labadie at Vanderbilt , or 225 miles east to Craig Buchman at UNC-Chapel Hill.

      The best independent description of the various CI’s is on Tina Lannin’s website: Be sure to see CHOOSING A BRAND – What you need to know in that article.

      As for whether Advanced Bionics has finally fixed their implant reliability problems is an open question: We’ll be at the Hearing Loss Association of America 2012 Convention in Portland in two weeks: We urge you to attend, as this will be your “CI Shopping Trip:” You’ll get to meet over 300 adults who themselves have CI’s, and you’ll be able to go into “anthropologist mode” as you have conversations with these people in both quiet and especially in noise. [If you attend, you can simply register for a free Expo Hall pass; however the workshops are quite good.] Please see what my friend Christie Nudelman found when she attended her first Convention here.


  9. Sheri Birnbaum
    June 14, 2013 at 2:15 pm

    Dan: The info is much appreciated. I wonder if this is what working on a Masters Program is like 🙂 . I stumbled on Buchman’s name when I got a recommendation from a neighbor (intelligent) to try their DDS. I went in not hearing (the usual – can’t read lips through masks and such) and the DDS talked about his 6-year old daughter who has had two implants and she’s six years old. So, based on what you said, I lucked out. I met with him last week.

    I’ve also got a mess of papers in front of me from Tina’s fabulous website. AB has had so so many problems and own so so little of the market that they are a risk (15% market share). I’m not sure how important it is they’ve fixed their problem du jour.

    I am retired and live on the other side of the US and cannot attend the conference. I will, however, be looking at the results. Right now, there are two viable options: Cochlear and Med-El. I don’t trust the stats listed in the website because there’s a lot of contradictory info about what real (joules, electrodes) and what isn’t.


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