Media - Sonova News Room
Sonova announces FDA approval for U.S. market re-entry of the Advanced Bionics HiRes 90K cochlear implant
Stäfa (Switzerland), 13.09.2011 – Sonova is pleased to announce the immediate market re-entry of the Advanced Bionics HiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics (AB) received approval from several other regulatory bodies, including Health Canada and the European Notified Body (TÜV), to resume distribution of the HiRes 90K cochlear implant to Canada and countries accepting the CE Mark. With the approval of the Food and Drug Administration (FDA), Advanced Bionics can resume distribution in the United States and re-enter all markets worldwide.
Advanced Bionics instituted a voluntary recall in November 2010 after becoming aware of a rare issue with the HiRes 90K cochlear implant. Of the more than 28’000 implanted HiRes 90K devices, only two (0.007%) explanted devices were confirmed to have the issue. In the months since the recall was instituted, Advanced Bionics implemented changes to its manufacturing process to ensure that there is no effect on the safety or efficacy of the HiRes 90K cochlear implant. While off the market, Advanced Bionics actively continued all research and development projects that were under way prior to the recall.
“We are very excited about this positive news. We put the safety of our patients first and have been rewarded with tremendous support from patients and professionals for our honesty and integrity. Our product pipeline is full and the road is now clear for growth in the hearing implant segment of Sonova over the next years,” says Alexander Zschokke, Interim CEO of the Sonova Group.
In December 2009, the Sonova Group took a strategic step towards expanding into the market segment of inner ear implants with the acquisition of Advanced Bionics. As part of the Sonova Group, AB’s joint work with Phonak continues for the development of effective and innovative technology in the area of implantable hearing solutions. These innovations include a higher-performance chip, improved algorithms, more advanced FM and wireless solutions and a new design approach.
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