Guest guest Posted September 13, 2011 Report Share Posted September 13, 2011 Press release, Sonova - September 13, 2011 --------------- 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. .............. Complete release: http://www.sonova.com/en/investors/news/Pages/fdaapproval20110913.aspx Quote Link to comment Share on other sites More sharing options...
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