Advanced Bionics: Fingers tapping…


As many  readers are aware, last week Advanced Bionics has received TÜV approval to ship newly modified HiRes 90K implants with the CE marque, with submission to the US FDA pending. Over the last four days, we have repeatedly reached out to AB media relations, corporate, and other individuals with requests for more information contained in their TÜV and FDA applications, specifically as to the steps they have taken in Engineering, QA/QC, and Reliability, to assure audiologists, surgeons, and most importantly patients that the failures that occurred leading up to the November 23rd “voluntary” recall will not happen in the future.

We are interested in presenting facts surrounding the steps Advanced Bionics has taken to improve the reliability of the HiRes 90K; and we await their reply.  If AB so chooses,  a reply may be posted in the comment section of this article; and we will publish it unaltered.

If anyone from Advanced Bionics wishes to contact us, we can be reached anytime at Dan@Snip.Net ~

3 June 2011 Administrative Update: When I removed the Disqus comment plug-in, the comment nesting was lost, so all comments are now listed flat

12 April 2012 Update: Removed the recall ticker~ 

 

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About the author

Dan Schwartz

Electrical Engineer, via Georgia Tech

24 Comments

  1. Franco Portillo
    April 21, 2011 at 5:59 pm

    There is a public tender in Mexico and Chile thus other sites in the globe where Adavanced Bionics have delivered hundreds of CI’s a week prior to the recall; they expressed to the FDA (and evidently in developed countries like England, Canada, Egypt, Saudi Arabia, India, etc) that they are doing a voluntary recall. This means exactly what it means, to pull implants from the shelves of Medical centers and/or governments agencies aim to help the deaf and re-test devices for faulty operations. However in some countries as seeing in some clinics today in Chile that they are scheduling surgeries for next week, with implants shipped before the recall, and they were never returned to AB for inspection, hence the same thing I Mexico where 140 implants were never return to AB for re-testing/inspection due that Mexican AB personnel never informed properly the regulatory bodies of Mexico / Chile at what they should be doing. Therefore, children under the age of 4 are aimed to be implanted under the uncertainty of implants to work properly or not, to over stimulate the auditory nerve. Hence grounds a permanent damage to the auditory system.


    • David Landsberger
      April 24, 2011 at 5:47 am

      Why would a company VOLUNTARILY recall a device and then try to sneak a few old ones in? That just doesn’t add up to me.


      • Franco Portillo
        April 24, 2011 at 6:34 am

        @David, no body is trying to sneak a few old ones, they have done a marvelous job all around with the RECALl, but there were 140 devices in Mexico that a panel of experts (surgeons) call up to my attention on their concern of devices still in Mexico and never return to AB. This is a fact, now they turn out to be in quarantine under the ownership of the Mexican GOV. I am just relaying on this blog the concern the surgeons call up to my attention.


        • David Landsberger
          April 24, 2011 at 7:04 am

          I’m confused. I must be missing some detail. AB sold 140 device to Mexico. Shortly after, there was a recall. I assume AB told the Mexicans to give them back. But then what? The surgeons wouldn’t so the mexican government took possession? If that’s the story, then the Mexican surgeons sound irresponsible, but everything is okay.

          So, am I missing something to the story?


          • Franco Portillo
            April 24, 2011 at 11:36 am

            @David, You have the first part wrong. The implants were sold before the recall (you misread), the panel of experts concern is they CI never went back to AB, the IC still in Mexico, and has not been tested; Second issue is time passing by on kids at 4 y/o who were scheduled to be implanted 6 months a go. The MEX gov taken possession of the goods to be quarantine is something I learn thru a statement on this blog from an AB officer. There is none intention of any tactics involved on disseminating this info; I call the news as it came.


      • Dan
        April 25, 2011 at 12:21 am

        David, what we are now investigating — although tangential to the engineering investigation of the “ugly fails” — is whether Advanced Bionics knew there was an impending “voluntary” recall, and chose to dump their stock of HiRes 90k implants into a third world country at a vastly reduced cost.

        This is why we requested Gerhard Roehrlein to furnish us with export documents, including bill(s) of lading, which would allow us to examine the veracity of his claim.


        • Jeffrey Simmons
          May 4, 2011 at 10:36 pm

          I’m wondering if you have even the faintest notion of what the failure mode was in the two (still only two) devices confirmed to have had a DC leakage issue. As I mentioned in previous posts, it really seems to me that your “investigations” consist of little more than unsubstantiated speculations. What are your “facts” yhat you’ve uncovered. Do you know a single thing beyond what has been in the press releases from AB or the FDA? What makes you so certain that an FDA-regulated manufacturer is even allowed to give you the information you are requesting while there is still a production hold going on?


          • Dan Schwartz
            May 6, 2011 at 5:50 am

            We don’t know whether it is two, as I have received reports of two more explanted devices meeting the criteria; and the FDA has not responded to our FOIA requests yet~


  2. Candy
    April 21, 2011 at 8:38 pm

    *Tapping fingers*

    ;o)


    • Dan Schwartz
      April 22, 2011 at 7:20 am

      Candy, since you’re a candidate to get implanted, you have a stake in the answers.


  3. audiologist
    April 22, 2011 at 7:02 pm

    Responding to the first comment. Franco should disclose that he works for MED-EL, a rival cochlear implant company. You should know better than to use such fear tactics. There is no way that AB would knowingly allow an unused device shipped prior to the recall to be implanted. The FDA mandated that all centers, hospitals, surgeons, and distributors were notified and that all devices were accounted for. That is standard. No regulatory body would allow AB back on the market if dozens of implants were unaccounted for.
    And no, I do not work for AB or any cochlear implant company.


    • Franco Portillo
      April 24, 2011 at 3:51 am

      You are lost somewhere in left field; I’m consultant not only to Medel to but other corporations in the field. Relax; I am here to speak based on facts and to seek that these Mexican children are treated with the respect they deserve as patients, for you information there is list of children near 4 y/o scheduled to be implanted 6 months a go, but due to the circumstances they are still on the waiting list.


  4. Gerhard Roehrlein
    April 23, 2011 at 10:24 pm

    Response to Franco Portillo Comment on The Hearing Blog.com

    This is a response to Franco Portillo, who is a terminated former employee of Advanced Bionics and a current employee of Med-El. At Advanced Bionics, the safety and well-being of our recipients is our number-one priority. As an officer of the company, I can emphatically state that measures have been taken to ensure that no devices as part of the voluntary recall will be implanted in children or adults. In Chile recalled devices had been returned to AB. In Mexico any devices that are part of the voluntary recall are quarantined under the ownership of the Mexican government. These devices will be exchanged with newly manufactured devices as they become available. We are working with the Mexican government to provide newly manufactured devices for children and adults impacted by severe-to-profound hearing loss. AB remains committed to making a difference in the lives of those impacted by hearing loss. We ask that the Franco Portillo comment be removed immediately as it is factually incorrect.

    Gerhard Roehrlein
    Chief Executive Officer Advanced Bionics, LLC


    • Franco Portillo
      April 24, 2011 at 3:40 am

      Obviously you are far away from the reality, or your subordinates are not relating all ethical issues evolved, therefore I would have get you an statement from the panel of Mexican experts dealing with this situation, hence follow up at this forum, stay tune for feedback to your comments. Furthermore, you need to get acquaintance with real facts, not a terminated employee, I would recommend you follow up with your VP of Asian Pacific and Latina America or your ex CEO, not terminated dear Sir, but I quit, in case you need further information about reasons, and or agreement signed why I decline to work any further with AB, I’ll be glad to over with you on this forum any or common ground you might like.


    • Dan Schwartz
      April 23, 2011 at 10:48 pm

      It is the policy of The Hearing Blog to publish all (non-spam) comments unaltered. However, Mr Portillo has indeed made very serious charges we are now investigating, despite this issue being tangential to our engineering investigation of the implant failures leading to the November 23rd recall and steps Advanced Bionics has taken to remedy the problem.

      To assist our investigation, we also welcome any documentation Advanced Bionics can provide to refute the Portillo charges, including correspondence to the Mexican Health Ministry regarding the disposition of these 140 HR90k implants in dispute; and also the shipping date(s), and copies of the bills of lading &/or export declarations to verify your claim.

      _____________________________________________

      Mr Roehrlein, let me also repeat directly to you our request — since your subordinates chose to ignore — for more information, such as that contained in your TÜV and FDA applications, as to the steps AB has taken in Engineering, QA/QC, and Reliability to assure regulatory authorities, university and hospital ethics panels, surgeons, audiologists, adult patients, and most importantly, parents of infant and toddler patients (who don’t know how to communicate there’s a problem), that the failures that occurred leading up to the November 23rd “voluntary” recall and FDA-mandated production halt will not happen in the future. Let me remind you that this is the fifth implant recall in less than a decade; and more importantly the third recall of the HR90k since 2004 for the same package leakage defect leading to device failure.

      We also suggest you read our November 27th article titled Failing Ugly: Advanced Bionics cochlear implant circuit goes haywire; and followup December 10th Failing Ugly II: More on the Advanced Bionics Recall: Perhaps you can answer our readers why your company had chosen to not reply until this holiday weekend. More importantly, we invite you to correct any errors we possibly made in those two articles.

      (more in a followup comment…)


  5. K9-alerts
    April 29, 2011 at 10:29 pm

    Dan
    Can you Please post some references so we read for further information. Thanks.


    • Dan Schwartz
      May 6, 2011 at 5:52 am

      Unfortunately, there is very little, which is why our fingers are tapping.


      • Jeffrey
        May 22, 2011 at 3:11 am

        And yet, the lack of facts doesn’t prevent you from speculating and spouting off 


  6. Lisa Harbour
    May 23, 2011 at 5:05 pm

    Interesting article…People should be aware that AB wants to sweep their failures under the rug. I had a CI several years ago and it was a complete, dismal failure. Just in case anyone from AB reads this blog my last name at the time of my implant was Thompson. I was so excited in the days leading up to my implant because I had been assured that all the tests necessary were complete and that with some work on my part I would be hearing In just a few weeks. Well, to make a long story short, not so much. The doctor that did the implant didn’t test properly for auditory nerve viability on the left (implanted) side. As a result, the implant didn’t work at all. My point here is I am not sure if all the doctors and audiologists involved reported any of this to AB or not (although I did email AB personally). AB has never offered to help me in any capacity at all (save for one visit by one of their Audiologist to ‘map’ my CI)…..It’s been a long ride. It’s taken me years to come to terms with it. I still walk around with a magnet in my head that is useless. I have often wondered why none of the docs or AB hasn’t expressed an interest in removing the magnet or studying my case further to prevent this from happening to another person. I share this not to turn people away from getting a CI but to serve as a warning that you must be educated and understand all the variables involved in getting a CI. Also, everyone needs to remember that AB is a money making machine. Negative feedback or CI failures only impedes that.


  7. Jr_avilacamacho
    May 30, 2011 at 4:21 pm

    I live in Culiacan Sinaloa Mexico, My daugther´ll need the CI, she´s in the list of the goverment, but in right now i have a big confussion, the CI is AB. my daugther have 18 month.  i´m sorry but i don´t english.


    • Dan Schwartz
      June 3, 2011 at 11:04 am

      First off, you need to get your daughter implanted as soon as you can, because new research has shown 18 months is the upper limit for successful speech and auditory capability.

      Next, please read Auditory Therapy: The Missing Ingredient, as it has valuable information for you and your daughter.

      Finally, you are welcome to post in Espanol, as one of our contributors is a CI audiologist in Mexico City
      ~Dan Schwartz, Editor


  8. dr oscar reynoso
    August 18, 2011 at 9:55 pm

    I support the fact that thanks to this recall many candidates now will not be implanted due that now they do not meet mexican goverment criteria wich is 4 years old and as the company and the goverment have not taken actions to implant the patients again at list with other implants while the recall is resolv now what will the company tell to all those patients that their sons or daughters can not be implanted as after months of recall nos they can not be implanted
    I undesrtand a recall but 5 like mr fco portillo and the internet FDA says is not an industry problem this is something that you should be addressing i hope you can solve this issue you should pay attention to what your local people in mexico say or do, because the image of ABin mexico according to many people is that there are things not clear with the adquisition of the implants this is something you should investigate i hope it is not as AB is an important comany as i say these are rumos not evidence that something happened hope not


  9. hilalhussain
    January 31, 2014 at 4:48 am

    I need Gerhard Roehrlein email because i have some(35) deaf(hearing loss) children i want to contact with your ceo please .


    • Dan Schwartz
      January 31, 2014 at 4:27 pm

      I’m sorry, as I understand it Roehrlein is no longer with AB


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