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Advanced Bionics approved to reintroduce cochlear implant

Posted: September 14, 2011 5:24 p.m.
Updated: September 14, 2011 5:24 p.m.

Advanced Bionics was approved by the FDA to re-enter the market with its HiRes 90K cochlear implant. The Valencia-based operation is a subsidiary of Sonova in Switzerland and is the only U.S. company manufacturing the hearing devices.

The FDA reported two recipients who experienced severe pain, overly loud sounds and/or shocking sensations with the HiRes 90K device 8-10 days after initial activation of their device. Advanced Bionics issued a voluntary recall in November 2010 after becoming aware of the issue.

More than 28,000 of the devices had been implanted successfully. AB implemented changes to its manufacturing process to ensure that there was no effect on the safety or effectiveness of the HiRes 90K cochlear implant.

"Everyone at AB and Sonova is excited that we are back on the market globally. We stand by our commitment to putting patients first and delivering high-quality products for the best possible hearing experience," said Hansjuerg Emch, group vice president, medical, of the Sonova Group.


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