Latest Cochlear Implant Recall & Others in the news

Added Oct 18, 2011 – latest article on the COCHLEAR co. recall:

http://www.reuters.com/article/2011/10/17/cochlear-idUSL3E7LH3JP20111017

Latest recall of cochlear implants due to failure and listing of past known recalls and/or fines.  NOTE: this post will be updated as more facts come in.

  • COCHLEAR, the co.,  announces it is recalling its “unimplanted” Nucleus CI500 range devices due to some failures.  As a result Cochlear co. shares have dropped. Cochlear plunged 20 percent to A$57.77 as of 1:47 p.m. in Sydney, wiping A$820 million from the company’s market value. (google for the latest on the shares dive)

“The financial impact of the recall is “difficult to predict at this stage,” Cochlear said in the statement. The company, formed 29 years ago to develop a so-called bionic ear invented by Melbourne researcher Professor Graeme Clark, has about 70 percent of the global market for hearing devices implanted in the snail shell-like part of the inner ear.”

“This recall is potentially a big deal,” said Angus Gluskie, who manages more than $300 million at White Funds Management in Sydney. “The CI500 range is Cochlear’s primary implant device, and a recall may impact short-term earnings, as well as possibly damaging its reputation.

http://www.bloomberg.com/news/2011-09-12/cochlear-slumps-most-in-7-years-on-recall.html

NOTE: companies don’t voluntarily recall their products UNLESS they absolutely have to because a recall and end to a production line of this scale deals a huge blow to their stock, product marketability, productivity, profit, and reputation.   Often the “voluntary” recalls are done to preserve the right to market their other brands, give the appearance of being proactive when in actuality it is in response to failures and concern that they will be fined and scrutinized more, and/or to get re-approval faster once the problem has been pinpointed and rectified.

To see more information – check the links at bottom.

ADDED 9/13 – article that has more details about how much COCHLEAR does not understand what is going on – why some of their cochlear implants are just shutting down.  Last line of the article shows the great IRONY and dangers of believing propaganda.  http://www.suntimes.com/business/7627305-420/bionic-ear-maker-cochlear-recalls-hearing-implants.html

Other unethical dealings, recalls, and faulty products by cochlear implant companies.

  • Cochlear Americas – (Colorado) – it is a branch of Cochlear ltd – was fined $880,000 by the US Department of Justice for insurance fraud (jacking up the cost of their cochlear implants for medicaid and medicare coverage) and kick backs (getting doctors, audiologists, hearing specialists, etc to recommend their brand of cochlear implants over other companies).

  • Advanced Bionics (California) has had several recalls and is awaiting approval from the Food and Drug Administration to resume sales in the U.S. after its latest recall due to a leakage that could lead to neural tissue damage.  (ADDED: Note: on the same day that COCHLEAR announced its recall of their ci500 range cochlear implants, Advanced Bionics announced FDA had re-approved their Hi-Res 90K cochlear implant)

  • Previously, Advanced Bionics was fined the maximum fee of $1.1 million by the Food and Drug Administration for switching their supplier without notifying the FDA nor having the FDA approval.  The cochlear implant was recalled “because of excessive moisture that could leak into the devices and cause device failure and possible surgery.”  The CEO, Jeffery Greiner, was also fined $75,000.

  • Advanced Bionics also produced a cochlear implant with a positioner that had an increased number of people coming down with meningitis post surgery of which some people died from.  Other Cochlear Implant manufacturers also have cases of meningitis post surgery.

  • Sonova, a Switz co. that brought Advanced Bionics, before the latest recall from its failing hot cochlear implant, filed a goodwill hardship due to losses from the world wide recall.

  • Otologics is a Colorado based cochlear implant company that was sued for trade secret theft and stealing talent away from a French cochlear implant company in its zest to try to produce the first 100% implantable cochlear implant.  It was fined $5.9 Million dollars.

NOTE: With all these cochlear implant manufacturers in trouble – just as COCHLEAR cornered the market while Advanced Bionics was out of commission world wide and still is for the U.S. Market, perhaps Med-El (an Austrian based lower end cochlear implant producer) will pick up the market while Advanced Bionics, COCHLEAR and Otologics (which didn’t even have its 100% implantable CI completed yet) are out of commission for their new CIs in U.S. markets.

One thing is clear though – cochlear implants the devices and the industry is not the cash crop that many folks originally thought and the Bubble may have ka-boomed a bit.

———

Links about Cochlear the co. cochlear implants in the 500 range recall

AAP

http://www.adelaidenow.com.au/business/product-recall-hit-cochlear-shares/story-e6frede3-1226134597453

The Australian Business with The Wall Street Journal

http://www.theaustralian.com.au/business/companies/ubs-slashes-cochlear-forecast-after-recall-of-nucleus-5-implant/story-fn91v9q3-1226134682395

Wall Street Journal (you must sign up to subscribe)

http://online.wsj.com/article/BT-CO-20110911-704154.html

Sydney Morning Herald

“The worst performing stock in the ASX 100 was Cochlear, which plunged 20.3 per cent, or by $14.68 to $57.50, after it announced it would recall of one of its hearing implant ranges. The implant manufacturer led the health care sector – the weakest on the market – to close 5.1 per cent lower.”

http://www.smh.com.au/business/markets/default-fears-spark-45b-selloff-20110912-1k50o.html

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17 Comments (+add yours?)

  1. Ella Mae Lentz
    Sep 12, 2011 @ 04:58:59

    ooohhhhh…..

    thanks as always for putting forth the truths about those companies that siphons off Deaf ears to fill up their pockets and does not give back to the community nor to the natural language.

    Wake up, wake up, folks…time for real resistance in addition to the exposure.

  2. Michelle Schoppe Dupre
    Sep 12, 2011 @ 06:11:16

    Oh boy! I knew it’s all about $$$$. Their eyes are becoming more and more green with money. Sigh! Hope it’s enough info to shake their world and wake up! They don’t care about the people – only what they have in their pockets.

  3. Nothing is Cheap in Medical Terms
    Sep 12, 2011 @ 11:43:21

    The company said it identified a recent increase in the number of Nucleus CI512 implants failing in recent weeks, with less than 1% of CI512 implants failing since they were launched in 2009. (25k implantees for this – meaning 250 have failed) – and they stopped and recalled it. Its the same thing, you get a knee replacement is about 45k, hip replacement about 40k. So nothing in medical terms are cheap – oh an also heart transplant runs around $670,000. So yea, every single one of those companies just want your money and just rack up the prices as high as they can go. 🙂

  4. Janis C. Tester
    Sep 12, 2011 @ 14:15:55

    Greed…bad karma got ya! The organic way is always better for the soul.

  5. infant
    Sep 13, 2011 @ 22:42:37

    12 months old Bilateral recipient just only last month shattered disheartened!! All stuff about life time warranty,Advanced technology safe,,, all gone. And he donest even know hes got 2.
    And people are talking about finances!

  6. handeyes
    Sep 14, 2011 @ 00:08:53

    heye all

    thanks for your comments. yes there is a HUGE profit margin with cochlear implants and perhaps the industry was a bit too eager to add bells and whistles in a quest for the lucrative bucks because recently we see more and more recalls.

    to the commentor right above – yes, I agree that it is disheartening that all the first news announcements to go out all revolved around the stock and the shares and the financial impact and not the impact on the infants and the children who may have gotten one of the duds or may have their COCHLEAR quit on them for no rhyme or reason.

    We dont see any provisions being made for them beyond – ohh they can just have the bad / dead CI512 replaced with COCHLEAR’s older model called Freedom.

    well, an explant and a new implant will take time to schedule and get available and involves new risks because every time u put someone under there are risks and every time you open up someones body there are risks etc

    and what of the time in which the child has no working COCHLEAR on and parents are still not given a fully natural and accessible signed language to use with the child while s/he awaits the new surgery and the new recovery and the new mapping and the new hopefulness that it will work and the new adjustment period and they new training and therapy and the new expectations etc

    An article in the Chicago Sun-Times addresses more of the human factor vs the profits and stocks
    http://www.suntimes.com/business/7627305-420/bionic-ear-maker-cochlear-recalls-hearing-implants.html

    the article concludes with the point you make: “Cochlear has promoted them as “a new design that is built to last a lifetime.”

    If your child just received bi-lateral cochlear implants at 12 month old – are they working fine? how do they determine if they are working with infants or children who can not answer questions yet? Are any of the specialists providing signed language to the child and your family? If the child’s implants are working – i hope signed language is still available and allowed for the child.

    You are right that it is wrong if all the media cares about is the profits and the stock and dont take stock in the infants and the children’s situation.

    Peace,

    Patti

  7. Daniel
    Sep 14, 2011 @ 05:04:04

    Great comments….A true reflection of how medical companies puts pressure on themselves to reduce time-to-market on their products resulting in immature offerings that puts people’s life at risk.Companies like Cochlear try to sell the “people” story to improve brand value but like a lot other money grabbers is in it for the profits only.As an insider, I can say that employees are leaving the companies in troops with certain departments like supply chain , procurement and design having a 70- 80% employee turnover.Is the failure of the device a reflection on the lowering of the standards both of people and manufacturing lines? The heads of design and manufacturing left the company 4-8 weeks ago after a 10-15 year service..The pressure is on with competition from korean and chinese manufacturers entering the market… but again reliability becomes an issue.It is a definite blow to the industry and the Goliath is on his knees and there are no new generation 100% reliable products in the markets now.and yes…the management made sure they got their bonuses before the recall was announced…

  8. handeyes
    Sep 15, 2011 @ 03:35:53

    Daniel

    thanks for ur comment. do u know any details like – when did the increase in “failures” hit and any thoughts on the possible cause of why they are quiting all the sudden

    management ….got their bonuses… – can u give us a link re: that

    again – thanks

    peace

    patti

  9. anon
    Sep 17, 2011 @ 19:47:25

    My mother was the recipient which upon finding it suddenly had stopped working caused the implant to be recalled. The facts are that 12 users now have to have the operation done again with a different company.

  10. handeyes
    Sep 18, 2011 @ 02:50:42

    Anon –

    Sorry to learn of your mother’s failing CI. I hope the surgery (explanting and new implanting) and new cochlear implant all go fine.

    as a commentor futher up noted – COCHLEAR has said that 1 % of ci500 range cochlear implants have failed and they have implanted 25,000 so i think that means 250 will need to be explanted (or more if more failures crop up)

    it is definitely more than 12

    Wondering if you can answer a few questions:
    1. which model of the COCHLEAR co. ci500 range did your mother have?

    2. COCHLEAR said they would be reimplanting with FREEDOM their older model cochlear implant – if your mother is opting for a different cochlear implant co. and brand – who is to cover the cost of that device? COCHLEAR or the insurance co. or your mother?

    3. Is COCHLEAR covering the cost of the surgery for the explanting and the implanting of a new CI or are the insurance co. or the individuals expected to cover that?

    4. How long was your mother’s COCHLEAR ci500 range cochlear implant working before it stopped?

    Thanks so much for taking the time to reply if you do come back and feel comfortable replying.

    Again I am sorry your mother has had this experience – i imagine it is very upsetting, worrisome, and stressful and again my wishes for all the best.

    Peace,

    Patti

  11. Susan Ci
    Sep 21, 2011 @ 14:55:21

  12. Dianrez
    Sep 21, 2011 @ 18:05:21

    This made me think of a comment I made on McConnells column about people having a right to expect 100% reliability, but his readers sarcastically laughed me out. They thought a certain margin of error in electronics is acceptable, when the same margin in automobiles was reason for Federally mandated recalls and multi-million dollar lawsuits.

    As long as this mentality persists in the industry and in people who might one day be consumers themselves, we aren’t going to see high quality control in devices implanted in the human body. A certain number of deaths or major discomfort, okay. Hundreds of people having less-than-hoped-for results or putting up with new daily disccomfort or reliability issues, absolutely acceptable.

    The only effective answer to this situation is not to have the CI at all. Unfortunately, many more parents and formerly hearing people find this unacceptable and are willing to take the risks and the margin of error.

    Incredible what desperate people will do for hearing.

  13. Munnu
    Oct 27, 2011 @ 06:17:43

    Now India is joining the list of countries where shady business in Cochlear Implants is reported. For details http://www.indiahearing.org.

  14. Joanna Wilson
    Nov 28, 2011 @ 03:25:59

    I am hearing echo and stanic sounds however It not clear and I been trying to tell the audiologist it not clear I can pick up some sentences but not as clear.too much echo involved I have the nuclus 5 implant lots of my friends I talk to on video phone are not happy with it either am I now how come I hear people who have the freedom implants they are HAPPY WITH IT the older verison of freedom can I request freedom without my insurance having to pay for it because it the fault of n5 companies? hope you email me what you have learned about this recall and i want the freedom one.

  15. handeyes
    Nov 28, 2011 @ 04:40:07

    Heye Joanna
    Im sorry you are not happy with your Nucleus 5 implant. My understanding of the recalls – it is only for the unimplanted CI 500 series and for the implanted ones – they are only recalling (removing / explanting) and replacing with the Cochlears Freedom – if those Cochlears 500 series have FAILED – stopped working but perhaps they are doing it for ones that are not working well also.

    Im not sure how you should proceed but your doctor, audiologist, and the manufacturer (Cochlear Ltd) – are probably the points of contact. if you dont get satisfactory results – i guess contact FDA and also a lawyer. there are several lawyers out there handling CI lawsuits

    They say they are built for life – which they are not and they also toot them as being state of the arts etc etc so if u r getting echoing and poor quality, they should want to make sure u are satisfied and the CI is serving u well.

    keep us posted of how things go and i do truly wish you all the best

    Note: i removed your email because sometimes it will invite spam for u but i have also emailed u this full comment as per ur request

    peace

    patti

  16. Arri
    May 03, 2012 @ 10:05:35

    Hi all! I’m thinking for a COCHLEAR implant in India, after reading all these news I’m little scared and do not know what to do. Any advice?
    Thanks & Regards

  17. handeyes
    May 03, 2012 @ 16:16:49

    Heye Arri

    the decision is a hard one. i have no advice but below are two sources of some info re: india and CI

    probably most important to ask yourself is:
    1. do you need a CI?
    2. if you got a CI, who would it be for?

    best wishes

    peace
    patti

    here is a link to a blog talking about corruption and monopoloy about CI industry in india
    http://drkumaresh.blogspot.com/2011/09/misuse-of-cochlear-implants-inside.html

    here is an abstract from a presentation at the Cochlear Implant conference in chicago this weekend

    I know some doctors in India planned to sue other doctors because they say there is a bit of a monolopy on pushing CIs and might be associated with a particular company or practice etc

    http://drkumaresh.blogspot.com/2011/09/misuse-of-cochlear-implants-inside.html

    There is a big CI conference taking place in chicago this weekend and one of the presentations is about CIs in India:

    Topic: Title: Author(s): Presenter: Abstract:
    Learning Objective: Email:
    Topic: Title: Author(s): Presenter: Abstract:
    Learning Objective: Email:
    Medical I Complications and Failures of Cochlera Implantation in 540 Recipients at Apollo Health City, India EC Vinay Kumar EC Vinay Kumar INTRODUCTION: Cochlear implantation is a relatively safe surgery performed on severe to profound bilateral hearing loss patients. Its surgical indications have increased and the age of implantation has decreased over the last years. As like other ear surgeries, it presents complications; device failure is one of the most important, given its potential risk for the need to explant and reimplant the device.OBJECTIVE: To evaluate cochlear implant complications & failures to determine possible causes and discuss medical and surgical management.MATERIAL AND METHODS: A retrospective study of cochlear implants was performed. A total of 540 implants for a period of 1994-2011 were evaluated. The sample consisted of 495 Pre-lingual and 50 postlingual, 309 male and 231 female, 503 children below 18 years and 37 adults above 18 years, 522 unilateral and 9 bilateral subjects, 387 normal anatomy and 153 abnormal ears were taken in the present study. The devices implanted were 487 Cochlear, 40 Advance Bionics, and 13 MED-El. Complications and device failures were analysed.RESULTS: The overall rate of complications was 7.9 % (44 of 540), with 32 minor complications accounting for 5.9%; 9 major complications, 1.67 %; and 3 reimplantations, 0.55 %. Reasons for revision surgery were device failure, infection. Revision surgery was performed in 3 of the 540 cases (0.55 %), Device failure occurred in 2 out of 540; 0.37 %) The risk of severe infection (eventually requiring explantation) was 0.18 % (1 of 540), 2 failure to implant (0.37%) and subsequently implant on contralateral side, 2 permanenent facial palsy (0.37%), 1 re exploration (0.18%) and 1 post-meningitis (0.18%) were occurred. The minor complications include 11 temporary facial palsy (2.03%), 10 wound infections due to magnet strength(1.85%), 6 CSF gushers (one needed CLD) (1.11%), 2 CSOM (0.37%), 1 cholesteatoma (0.18%), 2 device related issues (0.37%) were observed, all were treated Assess that cochlear implantation is a safe technique with a relatively low complication rate; however, certain complications may require specific attention to prevent or correct them. ecvinayakumar@gmail.com

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