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Cochlear Implant Failures

The product defect lawyers at Shoop | A Professional Law Corporation continue to take on new matters involving both the recalled, Cochlear Nucleus CI512 device as well as the recalled, Advanced Bionics HighRes 90k cochlear implant. No other law firm in the nation handles more N5 cases and claims than Shoop | A Professional Law Corporation. Both devices have been recalled due to defects in their respective manufacturing processes wherein the cochlear implants fail to achieve a hermetic seal. As moisture enters the device, it short circuits individual diodes which power the device. Although both companies maintain the implanted devices "safely shut down" when they are compromised, evidence has demonstrated that consumers (including very young children) have suffered extreme shocks as well as other organic issues related to these device failures.


Shoop | A Professional Law Corporation represents victims of Cochlear N5 failures from California to New York. Our lawyers have also successfully resolved Canadian-based claims involving N5 failures. No other law firm in the nation handles more Cochlear N5 failures than us. The Cochlear CI512 device was formally recalled by Australian-based Cochlear Limited in September of 2011.

Cochlear has admitted that its N5 implants were developing microcracks in their braze joints during latent manufacturing steps. This condition served to permit water molecules to enter the devices. This process essentially short-circuited the devices and resulted in the catastrophic failure of certain electronic components of specific electronic components (typically one of four diodes). Failure of these electronic components (diodes), in turn, caused the devices to shut down.

The lawyers at Shoop | A Professional Law Corporation advise recipients of failed implants or their families to contact an experienced product liability lawyer before accepting any cash settlement and releasing the company of any liability with regard to the failed implant. As an aside, It is always a better practice to speak with a lawyer in advance of signing any such release of any sort. Victims of failed cochlear implants are strongly encouraged to contact the experienced lawyers at Shoop | A Professional Law Corporation prior to entering into any such settlement agreement with Cochlear. See our prior blog post, below, regarding Cochlear implant settlements:


With regard to this implantable device, FDA review of failure modes for the Advanced Bionics HiRes 90k devices also noted failures in quality control to reduce moisture limits within the hermetically sealed cochlear implants. FDA noted further that two (2) of every three (3) vacuum bake ovens used for moisture removal had not been validated and that "process controls were not effective in detecting device leaks" and that Advanced Bionic HiRes 90k devices "have been distributed and implanted, only to fail due to an un-welded vent hole, a leaking vent hole and one device was determined to have been sealed in room air."

FDA lastly commented about the Advanced Bionics manufacturing practices, as follows:

"There is a lack of quality control and device sampling (and testing) to see if the implants are conforming to moisture limit requirements before the implants are being shipped and distributed. Advanced Bionics has been subject to punitive damages awards and its former CEO was fined an unprecedented amount by the FDA, individually, for egregious conduct.

The product defect lawyers at Shoop | A Professional Law Corporation encourage recipients of failed cochlear implants to contact us today to discuss their legal rights.

Shoop | A Professional Law Corporation
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