Cochlear Americas issues a recall

12 09 2011

Quoted from;

Cochlear said in its announcement that all existing recipients with a Nucleus C1500 series implant can continue to use their system as normal.

Cochlear said less than 1 per cent of CI512 implants had failed since its launch in 2009, but that it had identified a recent increase in the number of Nucleus CI512 implant failures.

To be cautious the company had decided to recall the Nucleus CI500 range of implants while it investigates the cause of the problem.

Read more:

Cochlear’s official statement on their recall and statement on their webpage

Here is the reliability chart that Cochlear pulled from their web site at the same time as they recommended using the CI24.


Update @ 13 September 2011: Cochlear’s recall of hearing device raises worrying questions

Update @ 16 September 2011: Latest News from Cochlear

Update @ 19 September 2011: Information from Cochlear for Candidates and Recipients

Update @ 05 October 2011: Moisture blamed for Cochlear implant malfunctions

Update @ 17 October 2011: Cost of cochlear implant recall up to A$150M

Update @ 18 October 2011: Internal Pictures Showing Malfunctioning Diodes

+ Picture of C1500 range (C1512/N5) implant circuit board showing malfunctioning diodes, on page 10.

+ Picture of C1500 range and C124RE (Freedom) implant circuit boards, for comparison – showing same microchip, on page 13.

Update @ 19 October 2011: Cochlear’s chief Chris Roberts discusses the hearing implant maker’s recovery since a voluntary recall last September wiped more than $1 billion off its value. Video after the jump, transcript is below the video.  Note that Mr Roberts said ‘The Nucleus 5 externals – nothing’s changed, we just changed one part of the system, the implant, no hearing performance has been compromised.‘… the Nucleus 5 processor is no improvement upon the Freedom.

Update @ 20 December 2011: Cochlear identifies cause of implant failures

Update @ 7 August 2012: Status of recall process

Comments from a previous post can be accessed here.



44 responses

12 09 2011

That was bound to happen!

12 09 2011
Sam Spritzer

I hate to be a purveyor of bad news but as much as this recall is long overdue, I have problems with CA suggesting older technology (Freedom) as an alternative. That is like me saying, “I have a brand new 1970 Ford Pinto for sale”.
I am also a little confused here. I thought the problem was with the internal device. Then the notice goes on to say that “The Nucleus 5 external devices (Nucleus CP810 Sound Processor) and any previous generation sound processors are not affected by this recall.”
So which is which?

12 09 2011
Howard Samuels

The chart has been reinstated on the Cochlear web site. Tina, it seems that your blog is quite influential!

12 09 2011

It would seem to me that the graph was deliberately not updated since November 2010 to conceal the true failure rate from prospective candidates and their families. The generation 5 device didn’t launch until 9/09. I don’t know how they can claim such a microscopic failure rate over 1.5 years by 11/10. Are they counting a handful of patients who trialled the device early as quality data, rounding up? If I knew it launched in late 2009, I would falsely assume that quoted 1.5 years of failue data would include through spring 2011. I bet their first failures started in nov/dec 2010. Actually, the FDA database should have that info right there. If that’s true, the coincidence is quite damning, and doesn’t paint a pretty picture. They report their reliability data, but fail to update it for 10 months, as the failure rate spikes.
Pull it off the site, maybe noone will notice! Shame.

12 09 2011
Howard Samuels

Rashed, better late than never.

Sam. look at the statement carefully. Cochlear is saying that the *external* processor is not affected.

But after all the talk and presentations about dozens of improvements for the N5 system, now Cochlear is saying that the N24 is just as good. Both implants still have only a single current source, and similar specs, so it’s probably true from a performance perspective.

12 09 2011
Sam Spritzer

Yea…better late than never should be their slogan.

If the problem is with the internal, then why are they suggesting the Freedom. Why implant an older technology? Why bother with new technology? I guess they think the performance difference doesn’t warrant waiting for their recall to be over with…like 10 months to a year from now.

12 09 2011
Robert MacPherson
13 09 2011

The internal Nucleus has been recalled, but not the external component. The only option at this point is to implant patients with the older technology (Freedom), but still use the external Nucleus component as it is still ok (which provides some access to newer technology). Patients are not yet showing significant differences in performance between the Freedom and the Nucleus, which is why Cochlear feels comfortable recommending the older internal device. However, I agree with Sam and several others, it makes you kind of wonder why there is even a new device if they are just as comfortable recommending the older one.

15 09 2011
Shopping For CI

Rachel, they are comfortable using replacement Freedoms because they are essentially the same electrode array with the exact sane chips. The only difference is in the stronger titanium casing and the smaller form-factor.

13 09 2011
Howard Samuels

Hi Rachel,

You are correct – if you choose the previous generation implant from Cochlear you will still get the Nucleus 5 external processor.

But there are two other options – Advanced Bionics and Med-El. And if you happen to live in France or a few other places, you can get Neurelec too.

Cochlear has been making a small number of Freedom implants. This recall is due to a 0.6% failure rate in recent months (which seems like it may be a different issue than the MP2 ground electrode problem). Because Cochlear is still in the early phases of investigating the cause of the failures, It isn’t clear how they can be comfortable that the previous generation implant, with basically the same electronics, doesn’t have the same problem.

14 09 2011

AB just got FDA clearance for their device today.
Interesting development.

15 09 2011
Howard Samuels

Evan, look at the failure trend chart on figure 2:

Click to access citi_cochlear_20110913.pdf

It does seem like an amazing coincidence that the published reliability chart ended November 2010.

15 09 2011
Sam Spritzer

An interesting observation…the number of Adverse Events. In May to Sep 2010….double digits. Then that picks up again after Nov and literally doubles that of failures. This seems to indicate there are other issues besides the outright failure. It sounds like the devices are going through a slow death. I am inclined to think there could be a leak or a burning in short of some sort? Howard…thoughts?

15 09 2011
Howard Samuels

Sam, forget about the total adverse events. Those include medical problems unrelated to the implant itself. For example, sometimes an implant is removed due to a persistent infection.

After removing the medical adverse events, the authors plotted actual device failures. I can’t really speculate on the root cause, but most things experience some ‘infant mortality’, followed by a long period of reliability, and finally end of life. This is called the bathtub curve, because that is the shape over time of the failure rate.

So one question that CI512 recipients have is how long is the infant mortality period? In the case of the 2 AB failures that prompted last year’s recall, that period was determined to be 7-10 days. But AB was only able to figure that out once they had the root cause mechanism.

16 09 2011

What I would be worried about is that they have been having these problems for a year and they still have no idea what is causing it. I dont understand how they can have a manufacturing/engineering defect that they can’t identify. Yet, they recommend the freedom as a substitute. Who’s to say that the same unknown manufacturing problem is not now going to plague the freedom as it is ramped up again to meet demand. It’s probably the new device itself, but if it was a simple flaw they would have detected it already. My surgeon friend/neighbor came back from the meeting and we had a chance to talk. Per his sales rep- 160 failed devices worldwide with increasing frequency over the last year. The explanted devices are returned and dissected back in Australia. They still don’t know the cause. AB had 2 problems, explanted and examined them, and knew the cause of the problem. That’s a VERY bad sign. Apparently they changed some aspect of manufacture and testing to “solve” the problem, that they couldn’t identify (and they still didn’t see fit to inform anyone), about without success. It may have actually made things worse. My friend and his colleagues were furious to hear of so many failures at the meeting. Their Reps NEVER said ANYTHING to them about problems/failures. Always “the most reliable” with 12 month old statistics to back it up in all their literature. He implanted 2 people last week! He’s beyond pissed and probably won’t use cochlear products in the future. He’s actually already scheduled meetings with MedEl and AB. 😉 Of course they’re happy to get a chance, he was 100% cochlear.
BTW, I know/follow all this because my mother needs a CI soon for worsening hearing loss. I looked into them years ago and found the whole thing fascinating from an engineering perspective. And, my friend and neighbor is an implant surgeon.
I’m appalled that this industry leader that I had stock in, and told my mother to get, could decieve people for a nearly a year before finally coming clean. They obviously don’t see it that way. No harm done, right? BS!!! What about the patients with failed devices and multiple surgeries. The thousands of others waiting in fear of failure. The surgeons look like buffoons for not knowing about all the failures. But, who looks at the FDA database and compiles that data. Oh yeah, the manufacturer does, AND they know the details of the failures. I said it before, SHAME! Ruthless profiteers. When this all sinks in, I see them losing all credibility.
What’s their answer for why it took so long for a recall? Why not notify the surgeons that there MAY be a problem? Where’s the commitment to the patients? Their failure rate jumped from a widely reported 0.03% to >.6%, and FAR higher in the last few months looking at recent implant data, and they waited and cashed the checks while they were the only game in town. Record profits while their device was having record failures. Think about that.

16 09 2011
Howard Samuels

Hi Evan,

I agree, no implant can be perfect all the time, but we expect medical device manufacturers to respond to an issue with transparency and alacrity.

Just based on the numbers, this recall doesn’t seem to be related to the MP2 problem that Cochlear quietly mentioned to the medical practitioners a couple of months ago. However, if it is the same problem, it would mean that the other electrode is also failing at a high rate. And if that were the case, then sending a quiet memo to practitioners leaving it up to the surgeon whether to leave a defective device in the patient doesn’t appear to be an abundance of caution.

Cochlear’s public statements say that if the failure occurs, then the implant ‘safely’ or ‘simply’ shuts down. Maybe it is just me, but that appears to be a dig at AB’s 2 failures (0.007%) that prompted last year’s recall. AB’s statement didn’t sugar-coat anything – it said the failure would cause ‘excruciating pain’ and could lead to ‘permanent nerve damage.’ Fortunately, both patients removed the processor when they experienced pain, averting what could have been much worse. There is nothing safe or simple about a shut-down. It requires reimplantation surgery.

If the cause of the recall is in fact related to the MP2 failures, then Cochlear waited far too long to halt production. If the cause is not related to the MP2 failures, then Cochlear should certainly take the opportunity to fix that problem at the same time, so that the regulatory agencies only have to make one (admittedly more complicated) approval for return to market.

It always bothers me to learn of a surgeon or clinic that offers only one brand. It is not in the best interest of the patient to restrict the choice of implant. I don’t know about current marketing programs, but Cochlear has offered various incentives to surgeons and clinics in the past, such as discounts for exclusivity or volume discounts. I hope that this serves as a wake-up call to practitioners everywhere – don’t put all of your eggs in one basket.

I’m sure that Cochlear will learn from the reaction to the way that this was handled, and will be more forthcoming in the future. It is understandable that your friend doesn’t want to work with Cochlear going forward. But I do hope that once the dust settles, he will consider them again if the company earns his trust.

20 09 2011

I am literally sickened by everything I’ve just learned today.

My Cochlear device (Nucleus 5) was implanted May 4th and “turned on” May 31st – I was positively thrilled to be able to hear again. By July 26th I began experiencing intermittent failures and by August 19th the implant was pronounced “defective” by Cochlear’s Audiologist and their Engineers in Colorado that analyzed the test results. It was shortly after this that my implant failed completely and I was left in total silence.

On August 31st I had the explant surgery and was re-implanted with another Nucleus 5 device. I was led to believe that Cochlear had determined the root cause of the problem and that I would be certain to have a “good” one re-implanted — this was conveyed to me by Cochlear’s Audiologist.

My Audiologist contacted me today to advise of the Cochlear recall and said we can discuss it in more detail three days from now when I’m scheduled for my initial stimulation of the device. I sense she and her colleagues are frustrated and feel they have not been kept well informed by Cochlear.

Curiosity had me researching to learn more about the recall and found I would have had the ‘Freedom’ re-implanted if my surgery would have been after the recall announcement. I missed it by less than two weeks due to Cochlear’s delinquency in issuing the recall. I have no idea if going backward to the Freedom implant would have been detrimental or not, but at this point I have very little confidence that I won’t be experiencing the same problems in 2-3 months with this Nucleus 5; Cochlear chose to continue manufacturing and shipping a product they knew had potential problems and with the root cause yet to be identified.

Intuitively I know the odds are in my favor that I won’t experience a second failure, but try convincing me of this on an emotional level when I’m still recovering from the surgery trauma and the pain still very fresh in my mind.

20 09 2011
Howard Samuels

Hi Pam,

I’m sorry to hear that your implant failed. How are you doing with your new device? My thoughts are with you, and I hope that the new implant provides you with a lifetime of hearing.

It’s a bit late to second-guess what would have happened if you been reimplanted with the Freedom CI24RE implant. But the electronics are exactly the same, so there is no decrease in performance going backwards, and conversely, the Nucleus 5 CI512 offers no performance improvement.

The two main differences appear to be the thickness of the implant and the impact resistance. The CI24RE is rated at 1 Joule, while the CI512 can withstand 2.5J. By comparison, Med-El’s previous generation implant is 2.5J, and last week’s product announcement didn’t mention anything about impact resistance. AB’s HiRes 90k is rated at 6J.

20 09 2011

Howard – thanks for explaining the difference in the Freedom and the Nucleus 5. If this replacement implant also fails you can be sure I’ll be switching companies!

At this point I don’t know how the new device will work – I have the first stimulation this Thursday. My fingers are crossed that it will worked at least initially and of course, long term as well.

30 09 2011

Please let us know how it goes. My daughter has to be re-implanted and we are making arrangements for the surgery in the next 2 weeks. Also, we told Cochlear America that they need to pick up the tab for all medical bills and they are pushing back. How did they treat this with you?

13 01 2012

Sorry for the delinquent reply – surgery, recovery, starting over with the programming and the holidays seems to have consumed the past three months.
Has your daughter had her re-implant? It must be extra frustrating to be the parent in a case like this – it was hard enough going through it myself.
As to your question regarding Cochlear picking up the tab for all of the medical bills….they did not pay one dime outside of the actual implant device that was under warranty. They insisted my insurance company pay for all of the bills; I was surprised that my insurance company agreed to it!

21 09 2011

I would have to say odds are overwhelming your new Nucleus will perform at least as well as the old one did….but without ANY of the failures. And it is my considered wish for you that all your CI problems are over.

Having said that, one has to consider the matter of reliability data, what CoH (Cochlear) knew all along and what was disclosed or concealed. My primary interest here is for the patient. It is not fair for a patient to be led to believe they have an extremely reliable device implanted in a complex surgery, and then find out they were lied to. And for Pam, someone had to be betting that lightning won’t strike twice. So we are seeing there is a streak of wilful deception somewhere in the Quality Reporting and Marketing machine of CoH. So what’s new ? Those who have followed the company for some time are well aware that it appears they stretch the boundaries of permitted behavior and pay their way out of fines when “caught” in a way that suggests they have calculated tha fines are a pittance for the ill-gotten sales procured in the interim. So…How many N5’s have they sold since Nov 2010? How many did they have to replace? The profits are mind-boggling. And that is the final bottom line, it seems.

As for the difference between the Freedom and the N5, CI websites have been saying they are essentially the same from the inception. What CoH puts into R&D compared to marketing, is an insult to patients. And CoH keeps telling patients they are being given the latest and the best. Just the same old tired stuff in a shiny new (oh yes, water resistant and …finally…almost as strong as the competition ) package.

When the company does not care to tell the patient the truth, who will? I would hope their Health Care Professionals would. But they obviously don’t. And there are those unscrupulous CoH – only clinics that should not even be in business. It is just unconscionable that given the well-known behavior of CoH, Medical professionals do not investigate the true failure and reliability rates on the FDA sites. To seem indignant when they hear of the current recall but have not done their homework (or apparently looked at their OWN failure rates…seems just a tad disingenuous.

Given the sorry state of things, I have to warn every recipient or family or friend of a recipient. If you do lean to choosing CoH, please realize you CANNOT trust what the company , Doctor or Audi tell you about this product’s reliability. Research on your own from blogs like this and CI sites such as Hear Peers, Hearing Journey, and the FDA site. If you still choose CoH, your performance and reliability are in your own hands.

22 09 2011

Editing my post:

Third paragraph…”difference between the Freedom and the N3″ should reas N5, not N3.

Later on, R7D should read R&D .

Sorry for the typos. Should have taken those typing lessons when I was a teen.

22 09 2011

Edited! 🙂

26 09 2011

My 9 year old daughter has been having intermittent problems and the device just went totally out on Friday. Cochlear is sending new external devices to see if that is the problem but I do not have a good feeling about this. I am afraid she will have to go in for surgery again and that is a lot to ask of a 9 year old.

28 10 2011

I would be most appreciative if Dr V could post links to the FDA sites where the failure & reliability data can be accessed.

I’m REALLY new to the world of CI, because I have a son (6) who needs (at least) one, and the first we heard of the recall was yesterday when we went in to the Audi for the device demo. We were really leaning towards the N5… Not sure what we’ll do now.

But I feel like Cochlear is getting bashed around a bit, and I know a little bit about a couple of things that might make it easier to understand where the company is coming from…

As to that chart that Cochlear has posted and the Nov. 2010 cut-off. The cost of producing their print marketing materials is doubtless many hundreds of thousands of dollars; they produced their 2011 materials in late 2010, so November was the most recent data they had at the time. And they will keep distributing the current materials until they run out of them. There is nothing sinister in that.. We attended an implant conference over the summer and one of the competitors was still distributing “we’re the best at __________” marketing materials from prior to the launch of the N5 – even though the N5 had objective information showing that the competitor’s model was NOT the best in the area claimed. Thinnest, most flexible.. whatever it was, the competitor was making a claim that was true when they printed the materials but was no longer accurate.

Point being, print materials don’t lend themselves to in-line updates.

And I suspect that nobody from Cochlear was in a position to disclose any spike in the failure rate UNTIL they announced the recall, because I have a feeling that for a sales rep or any other employee to discuss such a concern with an MD – especially if the MD were to hold any of Cochlear’s stock – that could constitute a violation of laws pertaining to insider trading.

Sad to say that publicly-held businesses can’t always do what is Right for Legal reasons.

As to their R&D efforts… I think if I were in their business, I might make changes to the implantable portion of the product VERY carefully; it could very well be that the electrode and the implant itself have a great deal of excess capacity, but they needed an edge to stay sharp in the marketplace, and the thinner case was thought to be a low-risk upgrade that people would want. Best laid plans….

Interestingly, I saw on the Cochlear ‘community’ site a post from a Cochlear employee saying that NO N5s had failed as of a date very shortly before the recall was announced. THAT might become a problem for them if it’s not strictly true, or it might indicate that the failures have all occurred over a REALLY short time span.

That’s why the FDA data mentioned by Dr. V would be such an important resource. I’m too new to all of this to have a real sense of how long their troubles have been brewing. Now that they seem to have diagnosed the issue as moisture captured inside the device during manufacture, this could be a very quick fix, or they might have to re-engineer the whole process.

28 10 2011

Hi Matt

The FDA site is known as MAUDE (Manufacturer and User Facility Device Experience). Product Class : “Implant, Cochlear.”

You’re bound to get some informational replies to your comments, so please check back!

11 12 2011

I can honestly say that I was personally affected by this recall, on 27th April 2011, i had my initial cochlear implant surgery and i was implanted with the C1512 Nucleus 5 internal implant.. it was going great until about a month or two ago when i informed the implant centre of problems and they arranged an integrity test persormed by cochlear. i had that test a few weeks ago and on thursday 8th December 2011 i was admitted back to hospital to have the failed C1512 internal implant removed and i was reimplanted with the freedom C124RE internal.
I am awaiting re-activation at present times and wont be until new year 😦


1 02 2012

Paul, please post your re-activation evaluation. I was gettng all high about a cochlear implant until I read about the recall and
now your personal problem. Thanks. In your share time please email me results.

2 02 2012
Jamie Skala

Hi Paul,
Our daughter was also affected by the recall. What is ironic is that her initial surgery was on the same day as yours. Hers failed on December 22, 2011. She just was reimplanted on January 17, 2012 and activated on January 30th. All seems to be going well so far, but we have lost some trust with Cochlear. Just wondering what your experience has been with Cochlear. We are very disheartened at the fact that our 9 year old daughter had to go through this. They have not shown much compassion at all.


23 10 2012

hello Jamie Skala
so sorry for the delay in responding to you,
since my revised operation which was on 8th december 2011 and
re-activation was (i dont have the date but think it was close to 21st december 2011) and well as for trust, obviously everyone who had to be re-implanted obviously had Cochhlear in their bad books but I have not really been that way. when i had to be re-implanted i was given a choice to change brands but I chose to stick with cochlear as i had already been unsing it since my initial activation on 26th may 2011 and felt if i go to another brand i would get quite confused.
today is 23rd october 2012 and just under 2 months till a year of my present implant (Cochlear C124RE freedom implant) and things have pretty much been the same reallty BUT what i fret it that in the future (i am 26 years old) if another implant comes out that is not compatable with the freedom implant we would be stuck and would haev no other than 2 choices, stick with the N5 processor or another operation sooner than if we still had the C1512 implant.
im just thankful that I was not bilateral implanted back in april 2011 or it would have been double trouble.

I am doing ok to this day and happpy i guess that iv got hearing with the Cochlear Implant i have now (C124RE freedom internal and Nucleus 5 processor)



ps i wish your daughter the best with her cochlear implant journey

12 09 2013

Paul, what is the integrity test. My implant was same time as yours and I still do not have acceptable results. I have just learned of the recall.


12 09 2013
Paul T

Hello Betty

an Integrity Test is a bit like a mapping really where they connect you up like they do when you have mapping only they use a coil attached to their own machine t is generally performed by a representative of the company which made the implant themselves) (aka Cochlear themselves) and there and then is when it is confirmed if the implant is failing or not.
With me they re-implanted me with C124RE before the C1512 totally failed.

Click to access LM158%20Casey%20Stach.pdf

14 09 2013
Paul T

very pleased and happy for your brother Oliver P that he was not affected by the C1512 implant recall. I heard that it was just a single batch of the C1512 implants that were affected (if I am correct) and all the other batches were fine.

30 03 2012
Bob Sickmond

You are scaring me. I’m going for a cochlear evaluation in early May as my new aids are not doing the job. Guess I’d better do a lot of research.from my first look at the 3 companies I thought Cochlear was head and shoulders above the rest.

30 03 2012
Sam Spritzer

Bob…there is nothing to be afraid of. If you do your research, you’ll find that no one single brand sticks out over the others. Where did you get the impression that Cochlear was head and shoulders above the rest?

10 12 2012
Paul T

I agree with Sam, please do not be scared Bob, in my opinion this recall was just a mishap and wont tend to happen again. you will be ok.
I agree with sam, do your research and well there is another brand now so you have a choice of 4 and look deep into them and the choice is yours. whatever your choice it will be respected. cochlear is a popular cochlear implant brand and Necurec is the newest one but we have AB and Med-el but as said earlier don’t let anyone “force” you into a brand, it is your hearing and your health so only you should make the choice and good luck.

23 10 2012
Doug Buskirk

I had my original implant on 3/3/11 and activation on 5/11/11. Failure and defective on 12/16/11. Re-implanted with a freedom device on 1/12/12 and re-activation on 2/25/12. So far no problems, but I do notice that the noise reduction is not as good on the freedom unit. It is very dishearting to learn that Cochlear knew about the defective with the Nucleus 5 before my original implant and I was never informed. Not very responsable. Maybe, a class-action lawsuit needs to be filed.

10 12 2012
Paul T

I never knew of that! and well I had the C1512 implant for about 8 months and so far as of 10/12/2012 iv had the freedom C124RE for a year now.
iv noticed that with the original implant and the one I have now are different but I just don’t know i’m just going to put up with what I have,
I am bilateral deaf and I cannot go bilateral because of the NHS NICE guidelines and just as well when I was initially implanted.


London, UK

26 02 2013
Olivia P

Has anyone had failure with the C124RE? My brother has two implant , the first he got before the recall. It is the C1512 , this implant has actually had zero problems. A year later he had to go with the C124RE in his second ear because of the recall. This implant has never worked and it has been over a year of them testing it and having him leave it out so his nerve can heal more. I just wanted to know if this has happened to anyone with the C124RE? I also wanted to know if someone has had an implant never work and then after re-implantation it work?

30 09 2015
Kathy Madden

I had the nucleus 5 C1512 implant august 2011- it is now Sept- 2015 and the nucleus 5 implant failed– after 4 years– i am scheduled for surgery for new implant cochlear 6- in October- I am somewhat worried about scar tissue that may have formed- and hope that the surgery goes smoothly- also want to make sure that cochlear is going to pay for anything out of pocket my insurance does not cover–

21 10 2015
Nicole thiefoe

my son also had a hard fail,of his device! he got it in 2010 and it just went out last week!! please tell me how your device failed im worried about my son he doesnt talk yet but signed that the device hurt s him and said to me many times that its broken and will not put it on!!

8 01 2016
Estelle Snider

I am having trouble with my necleus cp810. I am wondering if they have also been recalled?

9 01 2016

Your cochlear implant company should be telling you if they have been recalled!

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