Advanced Bionics Corporation Announces FDA Approval for U.S. Market Re-Entry of the HiRes 90K Cochlear Implant
9/14/2011 6:35:55 AM
VALENCIA, Calif., Sept. 13, 2011 /PRNewswire/ -- Advanced Bionics (AB), the only U.S.-based manufacturer of cochlear implants and a subsidiary of Switzerland-based Sonova, announced today the approval of the FDA for immediate market re-entry of the HiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics received approval from several other regulatory agencies, including Health Canada and the European Notified Body, TUV, to resume distribution of the HiRes 90K implant to Canada and countries accepting the CE Mark.
"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. "The support we have received across the industry for our integrity has been incredible."
AB's first priority is the safety and well-being of patients, which is why it 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 this issue. In the months since the recall was instituted, AB 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, AB actively continued all research and development projects that were under way prior to the recall.
"Our upcoming launches and products currently in development will continue to lead the industry and help our patients hear their best and live a fulfilled life," said Dr. Gerhard Roehrlein, CEO and CTO of Advanced Bionics, LLC.
About Advanced Bionics
Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Founded in 1993 and working with Phonak under the Sonova Group since 2009, AB develops cutting-edge cochlear implant technology that restores hearing to the deaf and allows recipients to hear their best.
With sales in over 50 countries and a proven track record for developing high-performing, state-of-the-art products, AB's talented group of technologists and professionals from all over the world are driven to succeed, work with integrity and stay firmly committed to quality.
To learn more about AB and its revolutionary cochlear implant technology, please visit www.advancedbionics.com.
SOURCE Advanced Bionics