Cochlear Bionic Ear Recall Wil Cost Company Up to $150M

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A recent recall of Cochlear bionic ear implants will likely cost the manufacturer up to $150 million, as its best selling product, the Nucleus 5 hearing implant, will be off the market for at least six months. 

A Cochlear bionic ear recall was issued last month for the entire Nucleus 5 implant series, after an increasing number of customers complained about implant failures. In the interim, Cochlear is trying to convince all of its customers to switch to an older Cochlear implant model, the C124RE implant.

Cochlear launched an investigation into the cause of the problem and have discovered failures in one or more diodes are being caused by moisture entering the implant through a defective seal. This disrupts the transfer of information and power from the sound processor, causing the ear implant to shut down.

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Once a full investigation of the problem is complete, the company will need to run clinical tests and get the FDA to approve the implant again before it can be returned to the market. The FDA approval process alone could take as long as 180 days. Therefore, Cochlear officials have indicated that the Nucleus 5 bionic ear will be off the market for six months or longer.

A cochlear implant, or bionic ear, is an electrionic device that is surgically implanted to provide a sense of sound for individuals who are profoundly deaf or hard of hearing.

Photo via Wikimedia Commons, public domain work of the National Institutes of Health

Tags: Cochlear, Cochlear Implant, Hearing, Hearing Aid, Hearing Loss

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8 Comments

carlos
i had freedom and work the best never had problem with it until four years ago i got nucleus 5 i experience lot of fail with the professor and especially the battery……. if they sell too expensive stuff we expective to have a good stuff
kathy
i had implant august 2011, it just failed on me sept- 2015. I am scheduled to see the surgeon tomorrow and they have already scheduling surgery oct 12 2015- I am thankful they can get me in so soon, but worried if i sign of anything stating cochlear cannot be sued- because of the defective nucleus 5 replacement do i talk to lawyer first– not wanting to be part of a class action lawsuit, that means nothing to me in compensation, only the lawyer who first filed.
Carol
I am on my 4th implant . The first lasted 3 years shocked me the whole time. Was told if I replaced it it wouldn’t happen again. Guess, what , same thing. They switched to Nucleaus 5. I was told it had a 99% rating. Well 10 months later itj ust quit. They said oh well you are in the 1% that had the implant with faulty glue. They replaced it, but refuse to pay the doctors and hospitals, what my insurance didn;t cover. I had severe dizziness, they said the crystals in my brain were of. Thumped me on the side of my head and sent me home. Then I got dizzy and fell , messed up my rotor cuff. Had surgery on it. This has all been very unpleasant experience and very painful.
WALTER
GOOD LUCK! COCHLERAS AMERICA should be out of biz. My recalled C1500 was replaced with junk. Sound so garbled I cannot understand anything. An electrode has popped thru my skin, bleeding & leaking a yellowish jell. It caused severe nerve damage & blindness. Before you get anothere, please check on other side affects. People are dying from implants & I am 1 of them. $150 M? HUH! A joke considering they own 70% of market. Advanced Bionics makes $50-$60M/yr. CA makes that in a week. DO NOT GET THE FREEDOM UNIT!
Jim
4-4-12 surgery scheduled to remove failed and recalled Cochlear 500 implant. This will be replaced with Cochlear Freedom Implant (older proven model ) ??? The implant business seems to be having its trouble with faulty seals. There does not appear to be a Mfg. who is clean on this issue. Cochlear would like to spread their losses telling me that my personal medical ins. should pay the surgeon. Cochlear will pay for the new implant. That is really big of them. With a $150M recall i believe they can do better than that…….
Cassie
My two year old son was bilaterally implanted at 10 months old and was and technically still is advancing beautifully. His left implant failed about 3 weeks ago now and will need to be replaced. Incase you did not catch that, my two year old son is going to need another surgery thanks to the company installing a faulty product.
BevG
I had the Nucleus 5 implanted one year ago. I was hearing better with the two implants than I had in years and years. I could even hear music better! We own a business and I was contributing at a higher level because my hearing (with 2 implants) was absolutely remarkable. The Nucleus 5 failed in September of this year and now I’m waiting for Cochlear to schedule the surgery for the replacement. I agree with Joe: It is still surgery, and it is still a risk. The bottom line for me, thought, is that I want to hear like I had been this whole last year! Hoping and praying all goes well.
Joe
My son just had this implant instaled this summer. It is his senior year of High School. We had this done this summer to replace the original one that he has had from the age of three. Now he is going to miss school and try to get things caught back up after the several week instalation process. So far the company has been very accommodatingly good for seeing what we are needing to get this corrected. It is still surgery , and it is still a risk.

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