A Valencia-based hearing aid manufacturer has received federal Food and Drug Administration approval to reintroduce its previously recalled HiRes 90K cochlear implants to the domestic market.
Advanced Bionics, a subsidiary of the Swiss company Sonova, is the only U.S.-based manufacturer of cochlear implants. The company said Wednesday it has also received approval from other regulatory agencies including Health Canada and the European Notified Body, TUV, to resume distribution of the implant to Canada and certain other countries.
Advanced Bionics instituted a voluntary recall in November 2010 after learning of a rare issue with the HiRes 90K implant. Of the more than 28,000 implanted HiRes 90K devices, two implant recipients “experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device,” the company said at the time.
Following the global recall, Advanced Bionics said it “implemented changes to its manufacturing process to ensure that there is no effect on the safety or efficacy of the HiRes 90K cochlear implant.”
Earlier this year, company officials said they hoped to get the device back on the market in April but also said it might take until the fall.
Meanwhile, the company continued all research and development projects that were under way.
“Our upcoming launches and products currently in development will continue to lead the industry and help our patients hear their best and live a fulfilled life,” said Dr. Gerhard Roehrlein, CEO of Advanced Bionics.
“Everyone at AB and Sonova is excited that we are back on the market globally,” Sonova Group Vice President Hansjuerg Emch said in a statement. “We stand by our commitment to putting patients first and delivering high-quality products for the best possible hearing experience.”
Advanced Bionics is headquartered in the Valencia Industrial Center and operates a manufacturing plant in Sylmar. Founded in 1993, it has sales in 50 countries.