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 press release after the jump
Official FDA notice of PMA (Pre Market Approval) for the PMA supplement (090) applicable to the manufacturing changes made to the HiRes 90K implant in order to return to market.
Also… now available from Advanced Bionics, off the ear power options and a single battery option for bilateral users. Ideal for bilateral children.