Sonova Holding AG, the world's leading provider of hearing systems, is announcing today, that Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, has received CE mark approval from the European Notified Body (TÜV) for changes submitted for the manufacturing of the HiRes 90K™ implant. Advanced Bionics is in the process of resuming production and distribution of HiRes 90K implants in all markets that recognize the CE mark or do not require additional approval.
Prior to the voluntary recall of HiRes 90K™ announced on November 23, 2010, AB generated approx. 70% of its global sales in these markets. Sonova expects Advanced Bionics to resume its business in these countries over the next few weeks.
In addition, AB intends to submit the necessary documentation on the changes to the manufacturing process to the United States Food and Drug Administration (FDA) in the coming weeks.
"The CE mark approval is an important milestone for Advanced Bionics to resume its global business activities" said Alexander Zschokke, acting CEO of the Sonova Group. " I am confident that AB will regain its market position as one of the leading cochlear implant manufacturers very soon."
As part of AB's commitment to putting patients first and protecting the safety of its implant recipients, Advanced Bionics instituted a voluntary recall of the HiRes 90K cochlear implant in November 2010 as a result of a very rare technical defect. AB's investigation continues to show that of the more than 28,000 implanted HiRes 90K devices, only two devices 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 will update its expectation of the financial impact of the resumed business activities of AB
at its full year guidance 2011/12 on May 24, 2011.
