Advanced Bionics Announces FDA Approval for U.S. Market Re-Entry of the HiRes 90K Cochlear Implant

摘要

Advanced Bionics (AB), the only U.S.-based manufacturer of cochlear implants and a subsidiary of nSwitzerland-based Sonova, announced the approval of the FDA for immediate market re-entry of the nHiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics received approval nfrom several other regulatory agencies, including Health Canada and the European Notified Body, TUV, nto resume distribution of the HiRes 90K implant to Canada and countries accepting the CE Mark.