Why 2 Advanced Bionics HiRes 90K cochlear implants failed

31 07 2011

Straight from the horses mouth …

Two people out of 28,000 had a problem with their HiRes 90k cochlear implant and they were both successfully re-implanted with the same brand. The recall of the HiRes 90K cochlear implant is over and recipients in the US are waiting on the FDA to complete their paperwork. You can read about the root cause of the failure and voluntary recall in this letter from Advanced Bionics …

Letter: Advanced Bionics recall

Source: A letter from Advanced Bionics to the Ministry of Health Malaysia, Medical Device Control Division, dated 11/22/2010

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13 responses

31 07 2011
Catherine

There were some of us, yes, even me that were impatient with what seemed to be an overly cautious reaction from AB. But this article makes it very clear that the concern AB had was for the babies who may not have the ablility to knock their headpieces off. I had not thought of that, and any impatience I had evaporated instantly. It is with these recipients that CI’s do the most good!

31 07 2011
deafa

There’s a big difference between average failure and failing hot. failing hot is very dangerous and painful and that’s why AB react quickly. you want a implant be safe even if it failed.

31 07 2011
Don Martin

This claim is not entirely true. At least one of the two recipients is NOT doing well and the post-op performance has simply not recovered to where it was before. Please make sure you publish accurate information

1 08 2011
Admin

Details? More accurate information please?

1 08 2011
happy implant user

That’s pretty good numbers… 2 out of 28k, and they recalled immediately. I appreciate a company that reacts like that instead of waiting for backlash.

1 08 2011
Dan Schwartz, Editor, The Hearing Blog

VINDICATED!

We took a lot of heat from some ignorant people accusing us of speculation in our series of articles on the AB failures… We knew we got it right; and your documentation proves us right after all is said and done.

Dan Schwartz,
Editor, The Hearing Blog
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1 08 2011
Don Martin

If you are interested in publishing accurate information, request publicly that AB seek and obtain a “release of information” on the two (of 28,000) affected patients and publish just their (name obscured) performance data. I’m confident that the patients would give their consent. It would vindicate them very quickly and support your claim. (Patient privacy is not really a concern if you obscure the identifying information.) All we want to see are the pre-failure and post-failure discrimination scores.

2 08 2011
Admin

Hi ‘Don’

My information is accurate. If you’d like to demonstate you have more accurate information, feel free.

If all you want to see is the discrim scores, why don’t you ask them yourself? Patient confidentiality is a huge issue with me. All patient information is confidential to the hospital caring for them and to the patient. The cochlear implant company is not in a position to disclose anything more than is already public. Sorry if that’s not what you wanted to hear.

2 08 2011
Jual Jam Catur

I’ll got some more information about this. Recalling was a very serious action that the companies must have a very good reason to recall their product.

5 08 2011
Howard Samuels

Hi Jual,

The letter Tina posted is pretty detailed. There is also some more general information on AB’s web site. What other information would you like?

I asked Gerhard Roerhlein (CEO of AB) why the company recalled the implants when there were only two failures, and all implant companies have many more failures than that annually. He replied that while the incidence rate is very low, the severity could be high if the patient did not remove the processor. Later it was explained that AB was concerned about babies or people who for some reason would not or could not remove the processor if they were to experience any pain.

Don, you seem to know at least one of the two people affected. I think AB has only said that the two patients were successfully reimplanted. My interpretation is that the new implants are functioning normally. It seems that the patient you know about is not doing as well with the new implant. How is that person able to make a comparison, when the first implant failed within a week of activation? Did that patient have a hearing test within days of activation?

In any case, I doubt that any medical company would risk violating privacy concerns by posting details about particular cases. Perhaps you would like to invite the affected patient you know to share their story here. I too would be interested to know if the second implant is not functioning, as that would contradict AB’s statement that the patients were reimplanted successfully.

We all know that learning how to hear with an implant takes time and practice, and I do hope that your friend doesn’t get discouraged before putting in the usual effort.

10 08 2011
Johnny

Sorry Howard unfortunately although the two patients were successfully reimplanted and the implantations were a success i know that one is to be explanted again as the patient has gotten no benefit from it even though the implant is fine. AB would not have known this at the time the above letter was sent

11 08 2011
Adam

People keep saying how great AB is for doing a volutary recall – but surely a “voluntary recall” only prempts an Involuntary recall. By AB’s own admission the implant could cause “permanent neural damage”… there’s your answer. Yes all brands have faults, and all companies work to resolve them without necessarily needing to recall, but when something is potentially dangerous there is no longer a choice.

23 03 2012
Barb

I was implanted with a Vendor B CI, and developed excruciating Trigerminal neuralgia, the first time it happened was in a HLAA meeting, in front of a bunch of people. How embarrassing. Worse is that replacement hasn’t resolved the neuralgia; this has NOT gone away. To say there is no lingering after effects is ridiculous.

I now have 2 more AB CI’s needing replacement. I LOVE my CI’s just not the constant doctoring and replacement of them. The removable magnets should be removable and replaceable without causing the CI to malfunction, it seems another manufacturing problem is out there.

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