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End of AB Implant Recall in Final Stretch

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Advanced Bionics - May 27, 2011

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Documentation Submitted to FDA for Return to Market in North America

****Update: Documentation Submitted to FDA for Return to Market in North

America****

Advanced Bionics HiRes 90K Cochlear Implant

May 27, 2011

Advanced Bionics is pleased to announce that all documentation of the

manufacturing process changes implemented to address the recall issue was

submitted to the FDA on May 20, 2011. This submission is a significant step

towards our return to the North American market. The timeline for market

re-entry is dependent on the FDA review period and therefore cannot be

reliably predicted. We will provide additional information as it becomes

available.

Currently, we are in the process of building our inventory and have begun

shipping HiRes 90KT implants to several countries around the world that do

not require FDA approval.

In the meantime, everyone at AB remains firmly committed to providing the

first-class service relied on by cochlear implant professionals, recipients,

and their families.

Thank you for your patience and support as we resolve the HiRes 90K implant

recall and return to markets worldwide. AB remains dedicated to making 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.

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