Hi!
Below is an article about cochlear implants called "Advanced Bionics" just approved by the FDA as well as Health Canada:
Sonova announces FDA approval for U.S. market re-entry of the Advanced Bionics HiRes 90K cochlear implant
13.09.2011
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.
Below is a link to a press release from Sonova:
Sonova Holding AG - FDA approval 20110913
Hope you find this information helpful!
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