After nearly a year, Sonova Holding AG (SIX:SOON) subsidary Advanced Bionics was allowed back in the U.S. market with its HiRes 90K cochlear implant.
In the past few months, Advanced Bionics received approval to resume distribution in 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," Hansjuerg Emch, Sonova Group medical VP said in a prepared statement. "The support we have received across the industry for our integrity has been incredible."
The implant was recalled in 2010 because Advanced Bionics received reports that its HiRes 90K device malfunctioned eight to 10 days after it was activated. Two patients suffered from pain and loud noise due to device failure, according to the company.