FDA Reviewing Advanced Bionics Documentation for Approval to Resume Implants

July 2011

Advanced Bionics has received approval from several regulatory agencies, including Health Canada and the European Notified Body, TÜV, to resume distribution of the HiRes 90K(tm) implant to Canada and countries accepting the CE Mark. We are currently shipping newly manufactured HiRes 90K implants to more than 50 countries worldwide as we continue to ramp up production to meet the global demand.

For our return to market in North America, the FDA is currently reviewing all documentation of the manufacturing process changes implemented to address the recall issue. Per standard procedure, the FDA recently extended the duration of the review period to accommodate the volume of documentation provided to them. The timeline for market re-entry in FDA-dependent countries is subject to the FDA review period and therefore cannot be accurately forecasted. We will provide additional information as it becomes available.

Finally, we would like to provide an update on the status of AB's voluntary recall. Of the more than 28,000 implanted HiRes 90K devices, only two explanted devices were confirmed to have the issue. To date, there have been no other confirmed cases.

Thank you for your patience and understanding as we resolve the recall and return to markets across the globe. We appreciate your continued support of our mission to make a difference in the lives of those impacted by hearing loss.

If you have any questions about the HiRes 90K recall, please contact Advanced Bionics.