AB Update: Documentation Under Review by FDA for Return to Market in North America

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BobNote: The original " 30 day Notice " submitted May 20 has been converted

to a 135 day PMA Supplement submission.

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Update: Documentation Under Review by FDA for Return to Market in North

America

****Update: Documentation Under Review by FDA for Return to Market in North

America****

Advanced Bionics HiRes 90K Cochlear Implant

June 29, 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™ 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.