AB is back on the Market!!!

Yeap, you heard it right!  AB announced the re-entry of the 90K implant. Start calling your Implant Centre and start making those appointments to get your first CI or your bilateral surgery!!!! Cant wait for more and new exciting things in the future!

Here is the press release:

VALENCIA, Calif., September 13, 2011 – 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, TÜV, 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.

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