Advanced Bionics (AB) and parent company Sonova Holding AG have released a statement saying that it acknowledges the verdict of the Kentucky Western District Court. The case was brought by a patient whose cochlear implant malfunctioned as a result of moisture ingress.
The device in question was part of a voluntary recall issued by Advanced Bionics in March 2006. A jury recently awarded the plaintiff damages totaling $7.25 million. Sonova says that it will carefully review the verdict and consider an appeal.
In 2006, Advanced Bionics identified an issue related to the feedthrough assembly provided by one (referred to as “Vendor B”) of two approved vendors, affecting some, but not all HiRes 90K devices manufactured prior to March 2006. The company promptly initiated a voluntary recall of all unimplanted devices that contained the Vendor B feedthrough component and immediately ceased the use of feedthroughs from Vendor B.
The recall was already resolved prior to the acquisition of Advanced Bionics by Sonova in 2009.
The company press release ended by stating, “The HiRes 90K implant manufactured today is the most reliable device ever manufactured by Advanced Bionics leading the industry with a 99.8% reliability rate. Advanced Bionics is a global leader in cochlear implants firmly committed to the continuous improvement of the quality of its products and the reliability of its implants.”