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):
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.
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
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