Sonova announces voluntary recall of Advanced Bionics
HiRes 90K cochlear implant
December 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.
