Now hear this

Posted By John Coletti || 11-Nov-2011

Lawsuits have been filed against Advanced Bionics, manufacturer of the Advanced Bionics HiRes90k cochlear implants, by attorney Tim Edwards. The suits allege that the implants have a high degree of failure and that the company was long aware of the issues yet continued to market the implants.

Advanced Bionics began selling the device in 2004 and ran into several problems with it. The company ceased shipment of the device on one occasion in 2004 and in early 2005 indicated continued problems with the implant. The company also received a warning from the FDA about the implant. The warning stated manufacturing and quality control failures and other concerns. The following year, in 2006, Advanced Bionics issued a global recall of the implant (it was the second such recall), but it was limited to those devices using a component produced by AstroSeal. Advanced Bionics claimed the component was the culprit, and that about a third of devices with this component would likely fail.

In 2007 the FDA filed a complaint against Advanced Bionics and sought $2.2 million. Advanced Bionics agreed to settle but did not admit to any wrongdoing. Another voluntary global recall came in November of 2010 due to a couple instances of implant failure. Those suffering from these cochlear implant failures can be subject to very loud noises and severe pain. The failed implants must be surgically removed. Still, the company is hopeful it will soon be able to end the recall.

For more information, see this press release.

Categories: Patient Care