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Cochlear Implant Recall To Be Issued by Advanced Bionics

  • Written by: Staff Writers
  • 8 Comments

Advanced Bionics is preparing to recall some of their HiRes 90K cochlear implants due to potential defects that could cause pain and loud noises for individuals who have the devices implanted in their ears. 

The cochlear implant recall was announced on Tuesday by Advanced Bionics, which says it has notified the FDA of the recall. According to the company, they decided to recall the cochlear implants after confirming at least two cases where patients experienced malfunctions that resulted in severe pain, overly loud sounds and shocking sensations eight to 10 days after the cochlear implants were activated.

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

The recall affects certain HiRes 90k cochlear implant devices, and the company indicates that the risk of problems appears to be remote at present. An estimated, 28,000 implants have been distributed and the company has not provided an estimate as to how many patients may be at risk for problems.

Advanced Bionics is a subsidiary of Sonova Holding, which purchased the company last year. Sonova officials said that Advanced Bionics is working closely with the FDA to identify the issue with the hearing aid implants and resolve it. However, at the time of the recall on Tuesday, the cause of the cochlear implant problems was not known.

The Advanced Bionics HiRes 90k cochlear implant has been recalled twice before. The first time was in 2004 for symptoms that are similar to those that led to the current recall; sudden pain, loud noises, popping sounds and intermittent functioning. The second recall was in 2006, when the FDA notified the company that it had changed components in the device without notifying the FDA and getting approval. Advanced Bionics paid the government $1.1 million in 2008 to settle penalties resulting from that recall.

In June, Cochlear Americas, a competitor of Advanced Bionics in the cochlear hearing aid field, paid the U.S. Department of Justice (DOJ) $880,000 for violating the Anti-kickback Act and False Claims Act. The charges came as the result of a whistleblower lawsuit in which the company was accused of paying kickbacks to physicians who prescribed their version of the cochlear hearing aid implant.

The FDA warns that the cochlear implants have a number of potential health risks. The agency lists the possibility of meningitis, facial nerve damage, cerebrospinal fluid leakage (leakage of brain fluids), infection, vertigo, and other potential problems.

A number of cochlear implant lawsuits have already been filed against Advanced Bionics as a result of alleged prior problems with their devices

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

CORRECTION 12/10/2010: An earlier version of this article indicated that 28,000 of the cochlear implants were recalled. While the press release issued by Advanced Bionics does not indicate how many of the devices were included in this action, the company is only retrieving unimplanted devices in distribution. No estimates have been provided by the company about the number of patients who may be at risk of suffering complications. We apologize for any confusion and concerned patients should speak with their physician.

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8 comments

  1. T L Reply

    AB’s recall does NOT affect all 28,000 cochlear implants. Correct information is on my blog at http://funnyoldlife.wordpress.com
    There have been 2 confirmed cases which were successfully re-implanted with the same brand. There are a further suspected 9 cases.

    In fact, there have been problems with all 3 major brands. These are on the MAUDE database. AB have stricter criteria for what constitutes a ‘problem’ compared to other manufacturers.

  2. foremanm Reply

    My son was one of the 9 pending supected and finally confirmed failed integrity test. In fact he has had 5 AB device failures. We felt like test subjects for the 90k device and treated as a part or product instead of a human being. We were forced to make hear wrenching choice after our final failure to make the extremely difficult decision to change technology to another entirely different manufacter.

  3. yama Reply

    Thank you for sharing the possible risks of CIs. Mightn’t you also share the obvious benefits?

    http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/CochlearImplants/UCM062843#a

    Thanks to Advanced Bionics my daughter is able to attend a mainstream (normal) school without needing an interpreter, speaks regular spoken English, is able to use the phone, reads above grade level, sings in key (sometimes), can fake an English accent, can hear traffic sounds and alarms, and can communicate with anyone who signs or speaks English. Thank you, AB. Yes, we take all recall notices seriously, but this “article” is a gross misrepresentation of the scope of this recall.

  4. Julie Reply

    to the above statement. Yes i will recognize your daughter is doing great. BUT have some sympathy for the parents children who ARENT doing great and who still do not have the ability to do what your daughter is doing. Your the lucky one so respect the children who arent so lucky. Like my son.

  5. julie Reply

    AH HAH! taking the negative remarks off this site! Shows you are GUILTY and shows EVERY CHILD CI DOES NOT WORK Perfect!

  6. michelle Reply

    My son is deaf and autistic and is on his second implant which he does not want to wear. This second implant is the one that they are recalling but because hes autistic I don’t know if its causing any problems or not. I don’t know what to do at this point but I just don’t know if its worth all the pain of getting a new one put in!

  7. MIKE Reply

    My 1st implant was removed and re-implanted in 2005.
    I thought I was going crazy….I was being shocked inside my head around the implant. AB flew me from OR to CA to “test” me. They found nothing and they said they’d “never heard of this type of problem”.
    At the same time I received the re-implant I elected to receive 1 in my left side thus having implants in both ears. I’ve had nothing but problems since the re-implant and implant in 2005. Same problems as before, shocking, loud noises and sounds even when the head piece is off of my head. In 2007 I had a “soft failure” and was suppose to receive my 3rd implant in my right ear. I received a call from Advanced Bionics saying that would not be happening do the the recall and I wouldn’t be able to receive a new one until the FDA ‘s approval. 1 of my 2 implants are “working” at this time while I suffer with the pain and not knowing when the left one will quit working….at that time I’ll be completely DEAF !!

  8. Margaret Reply

    Glad Advance Bionics lawsuit.. Why not some deaf kid say NO.. Leave the kids alone and don’t implant on their behind hear .. Some kids say cannot stand with two C.I. are not worth surgery complex and Encourage young children should find their lawyer against the Company. 40 lawsuit is still too much … SHUT Advance Bionics business FAILED!

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