Press release, Sonova - November 23, 2010
Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device worldwide. The device will be removed from the market as a precaution while the company works with the US Food & Drug Administration to address the issue.
This action is being taken in response to two instances thus far where the product experienced a rare malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations, at 8-10 days after initial activation of their device. AB is working closely with the FDA to identify the problem and institute changes to the product to ensure that the HiRes 90K has the highest quality for patients who use the device. This voluntary action is being taken as a precaution and the risk of adverse medical events is remote at present. A notification letter from the company to cochlear implant professionals and recipients is forthcoming.
Outlook for the remainder of the year
It is still too premature for the Sonova Group to predict the impact the recall will have on sales and operating income for the remainder of the fiscal year 2010/11 for Advanced Bionics. As soon as the Sonova Group is able to ascertain the fiscal impact of the recall, it will communicate this information.