Sonova recall Advanced Bionics cochlear implant

23 11 2010

Sonova has announced a worldwide recall of the Hi Res 90K cochlear implant. Two cases of patients experiencing severe pain, very loud sounds, shocking sensations, at 8-10 days after activation of the implant, led to implant removal and an immediate voluntary recall by Advanced Bionics. This means operations are on hold until the implant is made available to the market again. Advanced Bionics and the FDA are working together on solving the problem.

This recall doesn’t mean you need to have your AB implant removed. So ….. stop worrying!

I’m very impressed that Advanced Bionics has taken immediate action rather than sweep this issue under the carpet. I’m also very impressed that they have immediately stopped supplying cochlear implants until they understand the cause – even though this is a huge disappointment for those awaiting an operation.  Advanced Bionics clearly have their prioirities right – the recipient.

Sonova press release

UPDATE : 03 FEBRUARY 2011

UPDATE : 14 APRIL 2011 – HiRes 90K cochlear implant returns to European and other markets

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84 responses

23 11 2010
Elaine

Let’s hope that it will get sorted out soon because FDA still haven’t approve ClearVoice yet and that is taking ages.

I shall pray all will be cleared up soon…..I had implant failure a long time so I can understand the worry…..

23 11 2010
Katie-Louise

Well said, Tina.

I am 100% positive that Advanced Bionics will do anything they can to resolve this situation. It is the best way to put their shipping on hold just till they have sorted it.

They have done enough for us and has changed my life and other users alot and I don’t see a negitive future with Advanced Bionics!

AB all the way!

KL x

26 11 2010
Dan Schwartz

K-L, you proved how reliable the AB HiRes 90K implant is from mechanical shock. In fact, because the electrode did not extrude (pull out from the cochlea) shows that your CI surgeon installed it correctly, and tied it down properly.~

23 11 2010
Julie Hunt

Tina

This doesn’t exactly inspire confidence for those who have recently just been implanted with said implant though does it?? And I wonder why I’ve been having so many problems these last few weeks? I still am having problems and getting quite fed up of the weekly trips to my centre. Although, I think my issue is more of a mapping problem or just generally my brain adjusting, but now and again it goes loud, then it goes low on volume, But thankfully I haven’t had the experience of pain or shocking sensations! Is this why the BEA Meeting was cancelled do you think? It’s seems a coincidence?

23 11 2010
Funnyoldlife

Hi Julie

AB are being extremely careful by stopping production …. Just In Case. Two occurences is very rare. It is very unlikely that this will happen to anyone who has had their implant for years, as these two cases had problems at 8-10 days after activation.

In your particular case, it sounds like the normal adjustment period. I still get days when everything seems too loud, or certain sounds are too loud, or I want more sound …. it is still early days for me.

I’ve no idea what happened to the BEA meeting but I imagine all AB personnel are very busy dealing with this issue at the moment and patient safety has to take prioirity.

23 11 2010
Julie Hunt

HI Tina

That’s reassuring to know thanks, but I would imagine this is going to have a seriois effect on AB’s reputation surely? I’m still glad I chose AB though as it has changed my life and I am learning that I need to be patient. :o)

24 11 2010
Funnyoldlife

The way they have reacted has earned my respect. Not all companies would jump on a problem so quickly and take such decisive action. They are to be commended, don’t you think?

24 11 2010
discpad

They (AB) did .NOT. jump on this, at least publicly. Details to come soon.

24 11 2010
Julie Hunt

They sure do Tina! I’m not worrying about it, but I admit that at first it was a bit of a shock to see this news, but then you have to look at the overall success of the implants themselves and I still have 100% trust in AB. Two occurences is rare indeed and there have been 28,000 implants. Hope you are keeping well by the way?? 🙂

24 11 2010
Funnyoldlife

You’re absolutely right Julie!

I’m stepping the rehab up a gear in 2 weeks (when I get a breather!). I just bought the Harry Potter set and will power my way through that. I’ve listened to the first book FOUR times and I’m so surprised that I still can’t remember bits of the story – it’s curious how complex the auditory memory is. But that’s another blog post! The phone is getting more practice as well – it really needs to be done every day to ‘keep my hand in’ so to speak.

25 11 2010
discpad

Julie: I’ve identified a third (possible/probably) failure; though the CI audie who did the MAP did .NOT. inspire any confidence in her skills when I saw her work. That is why I put this in the possible/probable category…

Anyway, there were nine more reports, not just the two ex/implants.~

24 11 2010
Bruce

I’m definitely not worried, being 2 months post activation, and absolutely enjoying each and every second in the hearing world. This recall has only given me additional respect for them. Most likely, I bet they will discover this to be either surgeon error, or the 2 bad implants were handmade by a new trainee, and something was overlooked in the Quality Assurance tests..

Seeing as it was voluntary, and not mandated by the FDA they wlll likely be able to resume shipments once they determine the issue (if any) with no restrictions from the FDA.

I definitely feel bad for those who were set for surgery on this date, and hope they can manage until they normal operations resume!

24 11 2010
Julie Hunt

Tina, I use my phone literally every day and answer the phone at work as well. Sure, some of the silly teachers still ramble on without even pausing when they phone me through the internal system, but I get the gist of what they are trying to tell me! I now phone the dentist, doctors and even the vets. I just explain that I’m deaf and they just need to speak a little slower, and they have all been brilliant with me. I’m still constantly amazed every day with what I can hear now, despite the mapping issues I’ve been going through, but I have every faith in my implant that it’s just going to get better and better as time goes by.

24 11 2010
Dan Schwartz

@Tina: I’ll probably have a blog post later tonight on this. If I post it, I’ll email you the link so you can quote it.

@Julie: Ab has built over 40,000 implants as of July; and there are over 200,000 people worldwide with CI’s from all four mfr’s. In your case, it’s a MAP issue: If you had this rare failure, you’d be ripping the magnet off of your head!

@Bruce: These are not hearing aids: These are implanted electronics, with multiple levels of component testing, system testing, seal testing, and burn-in. [In case you didn’t guess by now, I’m an Electrical Engineer and an old farmhand at RCA!]

2 01 2011
Donna

I have had the CI from AB since 2005. It has been amazing. So, when my device failed right before Christmas I rushed into audiologist for help. Now I find out this is the 3rd recall, and my device was on the watch list. No one told me to pay attention to this or that. I feel they should have alerted me. AB makes a great product. It is amazing to me that they cut corners by using an unapproved vendor, especially for a class 3 medical device. Now I have to have immediate remove and replace and AB is not shipping. So another device has to be implanted. Now I find out there is a larger than 30% failure rate on those of us implanted with Vendor B devices. And, the devices were not individually tested before they were shipped. I am very concerned.

24 11 2010
Bruce

Dan, I’m aware they are implants…. nothing in my post should have indicated I thought otherwise. The implanted components are handmade, not machine crafted… and with only 2 people who reported these problems, I’m sure it was isolated incidences Even with all those levels of QA, there has to be a common denominator somewhere which caused malfunction. Clearly AB is just taking a step back to look at the big factor, and find that common factor, and deal with it..

24 11 2010
Catherine Mellor

I have no intention of letting anybody recall my High Res 90K implant!

24 11 2010
Tim edwards

What PR company hired by AB is posting this propaganda?

24 11 2010
Funnyoldlife

What?! It is a PRESS RELEASE – not propaganda!

24 11 2010
Julie Hunt

Isn’t it still slightly worrying that this is the 2nd (or 3rd time) that AB has had a recall of their implants (the first being the Clarion??). Has Cochlear Ltd or MedEl ever had any serious malfunctions on their implants?? Not that I’m worried about my own implant, and although AB has to be commended for acting quickly and voluntary recalling the Hi Res 90K, I imagine that this is going to take them a quite a long time to find their place back on the market again, not to mention that the CI Centres all over the world may not be so willing to use it on their candidates in the future? Cochlear Ltd must be rubbing their hands with glee as they already hold 70% of the CI market. Well, I can hear the oven fan going in the kitchen and I’m sat in the dining room so for me AB still rocks! 🙂

24 11 2010
Funnyoldlife

@Julie. All brands malfunction but the percentage is absolutely tiny – all 3 major brands are very reliable. MAUDE (Manufacturer and User Facility Device Experience) is the FDA database of reported cochlear implant problems. Open the Product Class drop-down list, and choose ‘Implant, Cochlear.’ Choose the results per page at the bottom. Click in the ‘Brand Name’ column to see a description of the problem, including whether the device had to be explanted. You can also see how many problems occurred with each manufacturer.

Cochlear has similar problems – in the MAUDE database above, a search of all brands will show a report from Cochlear on 10/28/2010 for a Nucleus, see the third one down. It says

‘Per the clinic, the patient experienced poor performance and pain with stimulation, resulting in the decision to explant. The device was explanted (b)(6) 2010. There are currently no plans to reimplant the patient with another device. The patient was previously implanted in the contralateral ear.’

Did Cochlear immediately stop distribution of cochlear implants to find out what was wrong? No. Did they voluntarily carry out an investigation to locate the problem? No. Interesting, isn’t it?

26 11 2010
Anonymous

Tina –

Please note that in the MAUDE database, almost all Cochlear devices are Nucleus 24 (CI24M and CI24R), which has not been made since 2003 when Nucleus Freedom was released, and Nucleus Freedom (CI24RE), which has not been made since 2009 when Nucleus 5 (CI512) was released. There is no need to recall Cochlear devices that are no longer in production. Also, if you had read thoroughly all of the details of the reasons of re-implantation for Cochlear devices, most were due to patients having infection requiring the implant to be removed so that the infection could be healed. The patient of which you’re speaking from 10/28/2010 had a Nucleus Freedom, which like I said, is no longer in production.

Moreover, it’s expected to see slightly more Cochear failures than other brands, as Cochlear has a huge market share – 70 percent market share.

26 11 2010
Dan Schwartz

To “Anonymous”

Yes, all three manufacturers have about the same overall implant failure rate (There is no FDA data for Neurelec, as it’s not sold or licensed in the USA).

What sets this failure mode apart is that it goes into overstim, which is a Big No-No.

28 11 2010
John Martinez

Good points about Cochlear. What really bugs me about them is that they were paying doctors to recommend their product. No wonder they have 70% share of the market! As a parent, it just made me sick to my stomach to think that some doctor might tell me to go with CA because their pocket was getting padded. I found out about this when I was researching CI’s for my son. Cochlear was fined $880,000 for violating the Anti-Kickback Act and the False Claims Act by paying various forms of illegal remuneration to physicians. You can read about it on the United States Department of Justice website here:
http://www.justice.gov/opa/pr/2010/June/10-civ-673.html

29 11 2010
Catherine Mellor

Dan, Is one possible reason for the overstimulation, the no-no that you speak of coming from the way the AB implant is built, each electrode having its own power source? Also, somebody mentioned earlier that these things are handmade. That doesn’t seem possible because they are so very tiny. It would be like trying to make the current CPS units in computers by hand. It doesn’t seem possible to make such fine moves with bare hands.

27 11 2010
Dan Schwartz

@Julie,

The proof is in the pudding: You’re already in the top tier of performance with your AB CI, since you can use the phone!

As I told you a day or two ago, enjoy your hearing; but be on the alert if suddenly routine sound “jumps” to being painfully loud.

You’ll do just fine!

24 11 2010
Dan Schwartz

Looks like from the email that went out Tuesday night 9:30PM EST (Wednesday 2:30AM UK), this is more serious than in the press release from Sonova’s investor relations department Tina cited earlier:

—————**** Recall Notification****

Advanced Bionics HiRes 90K Cochlear Implant

Dear Cochlear Implant Recipient or Parent,

Our mission at Advanced Bionics is to improve the lives of the hearing impaired, and the safety and well-being of our recipients is our first priority. Because we are committed to ensuring that our products are as safe as possible, we are voluntarily informing you that we have become aware of an issue with the HiRes 90K cochlear implant. The issue can result in pain, overly loud sounds, and/or sudden shock sensation in the implanted ear while the implant is receiving power. Thus far, our investigation shows that of the more than 28,000 implanted HiRes 90K devices, only two explanted devices have been confirmed to have this issue. There are 9 other patients with similar symptoms which
our investigations have not yet ruled out as related to this issue. For the two confirmed cases, there were no symptoms upon initial activation of device. However, the patients experienced symptoms after 8-10 days of use. Both recipients were re-implanted with HiRes 90K devices and their clinicians report that they are progressing well.

We are conducting an extensive investigation of this issue using an independent scientific research organization. Their current analysis suggests that, if present, the issue will first occur within 90 days of device use. However, the onset of symptoms may be delayed after initial activation, and they may continue to occur intermittently. In the unlikely event that this symptom occurs, continued device use may lead to damage to the inner ear and/or the auditory nerve. If you or your child experience pain related to implant use, remove the external equipment immediately and contact your cochlear implant clinician to schedule an appointment. If the evaluation of your device identifies this problem, device replacement is advised.

It is important to note that it is not unusual for cochlear implant recipients to experience overly loud sounds. Most of these cases can be resolved with standard troubleshooting, such as the replacement of external equipment. The vast majority of these cases are not signs of the issue described above and do not require explant of the device. We will notify you again as more information from our investigation becomes available.

We sincerely regret any concern this notification may cause. Advanced Bionics assures you that we will correct this issue and continue to improve our product reliability. If you have any questions regarding this letter, please contact an Advanced Bionics representative at 877-577-4628 (telephone) Monday – Friday 5:00 a.m. – 7:00 p.m. PST or http://www.advancedbionics.com (live chat) Monday – Friday 5:00 a.m. – 7:00 p.m. PST.

In order to assure the effectiveness of this communication, please complete the enclosed acknowledgment form and return it to us at your earliest convenience by using one of the following options:

E-mail: confirm@advancedbionics.com
Fax: 661-362-7621
Mail: Self-Addressed stamped envelope

25 11 2010
CJ

I have bi-lateral Cochlear Nucleus 24 implants and one side has been ex-planted and re-implanted. I have no use from any of my implants now due to significant non-auditory stimulation (shocking sensations) loud sounds and sometimes pain. I have had several opinions but nothing definitive or conclusive………its not just AB

26 11 2010
Dan Schwartz

CJ, there could have been other neurological issues with your N24 implants, as having three circuit failures of the same type would seem nigh well impossible. When you were explanted, the old implant should have been returned to the factory for failure analysis — And it may be “NTF” (No Trouble Found).

Ask your CI center to request from Cochlear for the report on your old implant. If you are in the United States, it WILL also be in the MAUDE database. If you are in Canada, maybe; and in UK, probably not.

25 11 2010
sammarcko

I had a feeling something was amiss over at AB. I’ve had my op inexplicably moved from Nov, to Dec, to Jan and now currently looking at Feb for a bilateral.
I’ve noticed how quick the sharks moved in from Cochlear Corp with answers to some pretty specific questions I asked some weeks back and they replied only once the AB recall was made public domain. Yep Cochlear corp wants me to reconsider. What has been unsettling for me is that no word has come from AB direct and I’m dealing with a pretty senior level at AB. Strange.

25 11 2010
Funnyoldlife

@Sammarcko. I received a letter from AB today, it is the same as Dan’s posting in this thread. They have an awful lot of people to contact – takes time ….

25 11 2010
discpad

Tina,

AB contacted the hundreds of people that are in the affected batch with just one mouseclick. If you received the full letter, mentioning the nine more possible cases, then that means your own implant is either:

A) In the lot that contained the bad batch of the failed component(s);

B) On the periphery, meaning it is within the time window, but that containes a different batch of the failed part in the same production lot.

Answers are still pouring in.

26 11 2010
Funnyoldlife

Dan, you’d better back up what you say. A lot of people read my blog.

My letter did not mention the 9 possible cases. It stated this is a very rare issue (0.007%) and – if present at all – will occur within 90 days of first using the implant. After 90 days, you are unlikely to be affected.

I’m still not worried.

29 11 2010
Catherine Mellor

Tina, I was implanted January 13th of this year, and have received no letter, nor do I expect one.

25 11 2010
discpad

@Sammarcko: Since you were already scheduled for surgery, switch to the MedElSonata TI100 implant with the 31.6mm FlexSoft electrode array, for two reasons:

1) If your CI surgeon was going to implant the AB HiRes 90K with the 1j semi-curved electrode in a lateral placement, the MedEl will give better performance because of the longer length and tonotopic matching, especially with music;

2) If your CI surgeon was going to implant the AB HiRes 90k with the Helix electrode in a peromodional placement, it could be weeks, maybe months, to fill the order backlog.

In any case, unless there is a compelling reason (about 2% of CI cases) to use a Nucleus, AB and MedEl will give you much better performance.

Which CI center are you using?

~Dan

25 11 2010
Brijesh

My kid is going for activation on Dec 2. He is implanted with HiRes 90K. I am in great ordeal. I wonder whether I have made a right choice or not and more than that about my son’s future. I would like to have enough feedback on this as much as possible.

26 11 2010
Funnyoldlife

@Brijesh. Please talk to your son’s audiologist about this issue. It is highly unlikely that there is a problem. Advanced Bionics are very concerned that there is a problem AT ALL …. they simply have the bar very high for quality control. This happens to other cochlear implant brands too … however they don’t voluntarily report it to the FDA nor do they recall their products to be on the safe side until they know what’s happening. This is why I have faith in Advanced Bionics – they have respect for their customers.

25 11 2010
Brijesh

My kid is going for activation on Dec 2. He is implanted with HiRes 90K. I am in great ordeal. I wonder whether I have made a right choice or not and more than that about my son’s future. I would like to have enough feedback on this as much as possible.

25 11 2010
Brijesh

please let me know what they have to say.

26 11 2010
Catherine Mellor

Brijesh, I was implanted with AB High Res 90K this last January of 2010. I know from this last year that these people knock themselves out to meet your needs. I had a minor problem with the battery charger, and I had a replacement within two days and an envelope for a paid return of the slightly defective battery charger. (The problem was that on one of the four slots holding batteries, it did not hold the battery securely enough for me to feel confident with it.) Also, one of the wires to the headpieces became loosely connected, irritating me with unexpected shut off’s and again I had my replacement almost before I reported the problem (and you can report your problems online 24/7)! I have no doubt AB is going to scrutinize every implant device in the future even more carefully then they have already done. Because of my experience with them, my surgeon and my audiologists, I can only continue waiting impatiently for the other ear to be implanted. I believe you can rest assured that when your son is activated, it will be because they know which batch of implants his came from and that it will be safe to turn his implant on, and that regardless of which batch his implant device came from he will be monitored extremely carefully. I wish you, your son and everyone involved a successful activation and successful hearing journey.

26 11 2010
sammarcko

@Dan as Tina says I hope you can back up. This Blog rates high in the credibility stakes
Thanks for the Med-EL suggestion I certainly will be taking a closer look.
AB was trying to schedule their only consultant surgeon willing to travel to certain MEA countries to work and train other surgeons who have experience on other brands other than AB and in my case this consultant from Europe was scheduled to do my sim bilateral but has been so far unable to satisfy the National Health Boards in my territory with certain required documentation. It is most unfortunate as AB has just entered the market and is well underway in the gearing up and penetration process- sending Audios off for training etc in a market where Nucleus is the only option.
Nucleus is definitely NOT an option for me but it has been amazing to see the cochlear corp sharks swim out of their cave touting the AB recall document in all their communications touting Nucleus as the only sensible choice. Ugh.

26 11 2010
Dan Schwartz

@Sammarcko,

Several things jump out at me:

First off, you don’t want a rookie surgeon or surgical resident placing (threading) the electrode. You want to find a surgeon who has performed and placed at least 20, preferably 50, of the given brand and type. This is especially true if your surgeon is going to place the better HiRes 90K implant with the Helix (perimodional) electrode, as opposed to the older 1j semi-curved array (lateral placement). I recommend the Helix whenever possible, as although it is harder to place, you will get a cleaner, purer stim and use less power.

As an alternative, especially if you were scheduled to get the HiRes 90K 1j electrode, the MedEl Sonata Ti100 with the FlexSoft array is a very good substitute, as although it too is a lateral placement, it is longer with more complete tonotopic coverage.

Since you are in the Mideast, I would recommend checking your option to go offshore for your CI surgery: Dr Vittorio Colletti in Verona, Italy is one of the very top CI surgeons in the world. Colletti also implants the much trickier (and rarer) auditory brainstem implants (ABI).

29 11 2010
Catherine Mellor

Of course you want the best, Dan! But even the best surgeon started off with no experience.

28 11 2010
Brijesh

Thnx for that

28 11 2010
Dan Schwartz

Failing Ugly is .NOT. speculation.

Advanced Bionics admitted five things in the FDA approved patient recall notice:

1) There were 2 confirmed and 9 more possible cases;
2) The 2 confirmed failures resulted in overstimulation without shutdown;
3) The 2 confirmed failures were “infant mortality” in the first 8 and 10 days (100 hours);
4) The 2 confirmed failures required explanting and reimplanting;
5) “…Continued device use may lead to damage to the inner ear and/or the auditory nerve.”

26 11 2010
J Smith

When were the original faulty implants fitted does anyone know just how fast that AB acted on this ?

27 11 2010
Dan Schwartz

@J Smith: My sources have told me a few people at AB have been working around the clock for over three weeks on this. This is a big black eye for AB; and that phrase has been repeated to me by several people.

That being said, for me personally, I’d still get an AB, as all manufacturers have problems.

27 11 2010
J Smith

I asked this question to find out what AB are saying I believe at least one of the faulty implants was from early 2009 Not so fast work then

27 11 2010
sammarcko

@Dan

Thanks recommendations are spot on. Just need to clarify surgeon…The op was to be done by a highly qualified surgeon who works for AB as their “roaming consultant” and free of charge. He works normally at a Dutch Univ ENT unit. He is also an electrical engineer. Nice combo for an implant surgeon. The local surgeon near me who has 400+ nucleus only ops under his belt would be observer only on his first AB implant experience. In other words the Dutch guy would do the threading.

27 11 2010
Dan Schwartz

The Hearing Blog: Failing Ugly: Advanced Bionics cochlear implant circuit goes haywire. Workhorse HiRes 90K implant circuit recalled as it can “Fail Ugly”

Short URL: http://TinyURL.com/FailUgly

And I have No Joy in publishing this article, either.

————–

In replying to a comment on Facebook, I wrote the following replies:

“###, rest assured, I am NOT joining the D’s — I’m as pro-CI as anyone on the planet, as I’ve seen firsthand how well they work. But this kind of “infant mortality” failure at 8, 10 (and a third possible at 11 days) is totally inexcuseable …in ANY kind of electronics manufacturing — Let alone high reliability. Everything inside the implant is rated for Manned Space Flight, so SOMEBODY in AB’s QA/QC/Reliability Engineering department miserably failed in their duty. This failure was avoidable; and it gives ALL CI’s a Bad Name… And the person responsible should be held accountable.~”

“###, engineering a circuit for High Reliability has been successfully done all the way back to Apollo, and further back. Yes, all three manufacturers have about the same long-term failure rate, which is within Manned Space Flight tolerances…. And, the HiRes90k is a robust circuit, proven since 2003… which is why I like it. But when a Bad Batch of components slips through the layers of QA/QC undetected, SOMEBODY inside AB did not do their job… And this FAILURE places hundreds of jobs in jeopardy, as well as spoiling the excellent reputation CI’s have.

25 01 2011
John Martinez

I think Dan is 100% correct in his comment about this being a Quality Assurance issue that was avoidable and someone should be held accountable. I love Advanced Bionics. I think they have a superior product. However, in a discussion with the head of the CI department at one of the foremost hospitals for implantation and deaf research, I found out that AB did *not* replace the people at fault when there was a recall for QA reasons in the past. That was a BIG mistake. The person or people responsible should be held accountable. There’s just no excuse. Under Sonova, AB has the opportunity to become the strongest implant out there. Since Sonova owns Phonak, they could potentially strengthen how their FM systems and hearing aids work with an implant. Powerful technology is there, but they need to clean house on some staff.

20 02 2011
Donna

I posted earlier looking for answers in December. My AB device was failing. I had to decide which product to replace the failing AB device. My CI was in the group that slipped through QA. I was doing so well with the AB device. Suddenly you are off. Power surge, On, and off. In Jan I had a Cochlear CI implanted in the opposite ear. Problems during surgery have left me with no sense of taste. I was fine after the first surgery. Now I am struggling with the Cochlear product, I cannot hear nearly as well with the new unit. I was pointed toward the Cochlear product. I wish I had, a little more input prior to surgery in January. The Med Al may have been a better choice. Those I talked to said, it was the smaller company and probably less reliable. Next step is to explant the failing AB unit. I would really like to know what you recommend to replace the failing AB Hi res 90k. When it is working?? I hear well. Unfortunately it is failing. When it fails altogether I will not be able to use the phone or communicate. Because I had problems with the last surgery, I am concerned and reluctant to move forward. At present I can taste nothing.

28 11 2010
Brijesh

Does anyone know the 2 patients who have been identified with AB HiRes 90k failure…what happened to the 9 other patients who were in the row, any updates, please.

28 11 2010
Dan Schwartz

@Brijesh:

AB has not released any further data, including date codes, serial numbers, or patient names for the 2 confirmed cases or 9 possible cases.

However, I personally know one of the 9 possible cases: I tok her to her follow-up appointment the day after her activation; and I was involved with helping her notify the AB Patient Rep five days ago.~

14 12 2010
Howard Samuels

HI Brjesh,

How did your son’s activation go?

1 12 2010
Catherine Mellor

Just thought I would tell you that I received my letter from AB about the recall today. It looks like it’s word for word the same as what Dan posted on the 24th.

3 12 2010
TC

This is a very big issue for AB or they would not have pulled ALL devices from the shelves. People think that – “O it’s only 2 failures out of 28,00” not so ! The HiRes 90K has been manufactured sense 2003. Let’s not forget the additional 9 additional implants that are in question ! There is a potentual of 11 failures ! Do the numbers folks if these have been produced for 7 years @ a rate of 4K a year ave, depending on your implant month via the batch produced time table, THIS IS A HUGE PROBLEM ! Why else do you think all non-implanted devices were pulled…..

9 12 2010
SM

Hi All.
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.

9 12 2010
Dan Schwartz

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 could be due to the shorter amount of time having the second implant, and/or damage to the cochlea due to a DC bias being applied producing bio-toxic byproducts and/or local pH changes inside the scala tympani portion of the cochlea.

10 12 2010
Dan Schwartz

To all:

I discuss this in detail in The Hearing Blog: Failing Ugly II: More on the Advanced Bionics Recall

Dan Schwartz,
Editor

14 12 2010
Piyush

My daughter Vandita had her cochlear implant surgery on 12th august 2010. I am worried after knowing the AB’s recall of Hi-Res90K due to said problem. Althoug, she has completed three months after activation and 2 maps done. She has no such complaint but i still worried because she is only 5 years old. Pl. tell me in which batch the problem occured? and why am i not contacted or received any letter from AB?. We have a very poor service of AB in our country(India).

27 12 2010
Melissa

Hi everyone , I have just been told by my Implant center in the U.K. that I am to go through for surgery in Feb 2011. I wanted the AB system but as we all know this has been withdrawn at present.

My second choice was the Nucleus 5 system. I have read that AB do not have an electrode array for mal formed cochlea. I have been diagnosed with Pendreds syndrome and have 1- 1/2 to two turns at best. ( According to my Audiologist)

My Question is should I wait for AB to come back on line ? Also funding for the surgery could be affected If I wait after March 2011 as the local Health Authority will be finding it?

HELP?

15 01 2011
franco port

For what I know there is only one manufacturer that builds custom made electrode to patient physiological specifications, that is Medel, perhaps you sure look into that.

29 12 2010
Angered Parent

My son, born profoundly deaf, was implanted at age 1 with a CII in 2003. A year later, Aug. 2004, he received his second implant (bilateral), a HiRes 90K. One month later, the first recall letter was sent out. We were not that concerned because we were told his implant did not come from that vendor. Unfortunately, my son was only 2 years old at the time and did not have the ability to tell us that something was wrong. He wore the HiRes implant for almost 4 years before we knew his device had failed. He never experienced pain, or shocking sensations that we know of, but he never liked that implant. He started slowly regressing with speech and hearing on that side. We explanted/reimplanted in April 2008, and found out a month later that his device did indeed have moisture in it. With his new implant, he started out doing well. We were playing catch up with speech for the first year or so and he started stuttering. The audiologist could never get his map to a level that should have been acceptable to my son. He has spent the last year slowly turning down the volume to the point that he will now only wear it at the 9 o’clock position. We are very concerned about this new recall (the third one in 7 years), because we are fairly certain that his device has failed again. He has not experienced shocking sensations this time either, but it seems odd to me that he has started regressing again after almost 3 years. So, we have done a lot of research and have been amazed and shocked at how AB has handled certain issues. Don’t be fooled into thinking they have acted quickly and voluntarily on this issue. They are certainly not telling us everything they know!
Even though my son’s first implant is still functioning well, it could at any time fail as well. I no longer have faith in the company or their product! My son has lost precious time in regards to language developement, he may never be where he could have been and we are considering reimplanting with a Cochlear device on one side.

23 01 2011
Piyush

I also lost my faith in AB and think, i have chosen a wrong company for my little precious daughter Vandita.

27 01 2011
anonymous

The biggest problem with AB is the fact that this is the 2nd or 3rd recall since they have been operating. No other brand has had recalls.

That’s a very worrying thing, and a big thing to consider when choosing an implant brand.

27 01 2011
Funnyoldlife

Wrong. AB is not the only company to have recalls.

27 01 2011
John Martinez

Funnyoldlife is absolutely correct – the other companies HAVE had recalls as well. It’s not just AB. I had a lengthy conversation with the head of the CI program at a prominent hospital and she confirmed this to us as well.

3 02 2011
1 03 2011
Holly

For the past year and half my daughter has been experiencing swelling around her implant site. She has been getting hematomas (blood clots) that fill the cavity where the magnet sits. She also has one of the recalled AB devices. For the first 5 years she had no problems but now it is happening every 3 months. We have had the site drained several times. Has anyone had or know of anyone with this problem. Advanced Bionics should keep a database of all patients with any known problem and they blew me off when I called them directly to find out if anyone else is having this same issue.

12 03 2011
MARY E

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. The management has adopted a ‘bunker mentality’ since the recall.

I’m not a disgruntled employee, but since Sonova acquired AB, the atmosphere has changed, its become more corporate, micro-managed and petty. 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 openly about their feelings.

12 03 2011
Funnyoldlife

That’s very sad and I find your post is distressing to read. I guess toxicity is sometimes a by-product of management style changes. I’ve been through that in the past and it was hell. I do hope things get better for you – please remember you are working for a company that makes a wonderful product which has given me (and many others) a lifeline. For that, I’m eternally grateful, and we are all indebted to Advanced Bionics and people like you who make it work. So a very big thank you from me!

27 10 2011
Munnu

Indian cochlear implant scenario getting into monopoly controversy. Visit http://www.indiahearing.org for details.

27 10 2011
Catherine

Munnu
I didn’t have time to read all of the link in http://www.indiahearing.org but I read enough to be saddened by the appearance of greed in monopolizing CI centers. I am surprised that the manufacturers would allow it. Is it just Cochlear?

28 10 2011
munnu

Catherine,

Initially it was Cochlear. Now, it is reported that even Advanced Bionics and Med-El have joined the cartel.

28 10 2011
CJ

I think its easy to form an opinion based on the experiences and the open letter of one surgeon. As we have seen in recent day’s, a ci failure or multiple’s there of may have a significant devastating effect on any of the implant manufactures. Controls beyond manufacturing and logistics would I assume be paramount to overall “failure” rate of such a device even if the end result of failure was found to be soft failure on no fault found. I detest monopolies if only for the purpose to “make rich” but consider it this way, what benefit would it be if Cochlear disappeared from the market altogether as a result of their current N5 recall. It would just be a loss to all the current users of their product, technology advances in their own field and the next in line would step up to become rich, receive the accolades and kudos and eventually die the same death. Not so 1.2M was wiped from their shares and they will be a much wiser and safer as a result. Where we live not every surgeon is able to provide a ci procedure but doesn’t feel his client has been “poached” either, but referred to his fellow colleague.

28 10 2011
Catherine

I am wondering if the CI manufacturers are trying to make sure that their products are implanted properly and are wanting to clear each facility and surgeon before letting them implant their product? Is this what you meant, CJ?

28 10 2011
CJ

There are so many physiochemical and physiological variables that can effect outcomes for ci recipients beyond the control of ci manufactures or even the specialists who installed the device. Almost by default however questions of reliability of device or capability of specialist would arise questioning the integrity of both. These are truly miracle devices that require the most stringent controls, we need to look beyond the fat margins and focus on our lives made better because healthy procedures are in place to protect the R&D and and next generation of better hearing devices. Just for the record I have had 3 ci’s each was wonderful in its own short time and experience but for reasons not entirely certain (most likely degenerating auditory nerve) they became of no benefit so I live for now in absolute silence accept for terrible tinnitus. I hope the rich ci company’s and select specialists may one day change that for me. An abi is a current possibly we are working through.

28 10 2011
Tina

I wish you well with your research and future hearing.

I plan to add information to this blog on ABIs. It’s a topic I find very interesting but I haven’t met anybody with one. For readers, there is some information on Hearing Loss Web plus an interesting blog post.

28 10 2011
Catherine

Fascinating news about ABI’s. I hope it works out for you, CJ, and that your tinnitus disappears.

28 10 2011
Tina

Added: A moving blog on an amazing little girl called Alicja, who is looking at an ABI.

29 10 2011
Dan Schwartz

CJ, although I’m behind in my postings here on Tina’s site, I want to direct you to two resources you should definitely tap to find out more about Auditory Brainstem Implant (ABI) technology, of which about 1200 people have implanted in them:

1) The Auditory Brainstem Implant Technology group on Facebook, where you’ll find about 70 users, along with a few candidates and Hearing Care professionals;

2) Among the group on Facebook are 3 of the 10 recipients worldwide of the penetrating ABI, the PABI;

3) My friend Karen Lichtefeld from Louisville is the subject of Hearing With Our Brain in Hearing Loss Magazine, which details her journey from her initial diagnosis of neurofibramatosis type 2 (NF2), through the cruel surgery that stole her hearing in order to save her life, on through her triumphant return to the hearing world with the help of her ABI.

Dan Schwartz,
Editor, The Hearing Blog
Follow The Hearing Blog on Facebook

Send me a Friend request on Facebook

29 10 2011
CJ

Thanks Dan, I will connect via Facebook. I’ve just had my ci’s ex-planted (at the request of and abi surgeon) and I have to get an up to date MRI and then want to be sure funding is in place before connecting much… regards

28 10 2011
CJ

Thanks Tina, we met with Dr Bob Shannon for a couple hrs when he was in our area earlier in the year.

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