Stafa, Switzerland — Sonova Holding AG, parent company of cochlear implant manufacturer Advanced Bionics (AB), announced that it has received CE mark approval from the European Notified Body (TÜV) for changes submitted for the manufacturing of the HiRes 90K implant, which soon will resume production. The product is still not available in the United States.
Distribution of HiRes 90K cochlear implants will be resuming in all markets that recognize the CE mark or do not require additional approval.
On November 23, 2010, Sonova notified the US Food and Drug Administration (FDA) that it was voluntarily recalling its HiRes 90K cochlear implant device worldwide. AB reported that the action was being taken because of two known instances where HiRes 90K cochlear recipients experienced severe pain, overly loud sounds, and/or shocking sensations, at 8 to 10 days after initial activation of their device.
Sonova stated in its recent announcement that AB’s investigation continues to show that of the more than 28,000 implanted HiRes 90K devices, only two have been confirmed to have a technical issue. AB concluded the root cause analysis in January 2011.
Since that time, AB has implemented changes to the manufacturing process to ensure that no further implants will have this defect.
Sonova expects AB to resume its production and distribution in the CE mark territories over the next few weeks. In addition, AB intends to submit the necessary documentation on the changes to the FDA in the coming weeks.
Sonova will update its expectation of the financial impact of the resumed business activities of AB at its 2011/12 full year guidance on May 24, 2011.