COCHLEAR LIMITED — Regulatory Filings 2011

Sep 11, 2011

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ASX / MEDIA RELEASE

11 September 2011

COCHLEAR ANNOUNCES VOLUNTARY RECALL OF NUCLEUS CI500 COCHLEAR IMPLANT RANGE

Cochlear Limited (ASX:COH) is undertaking a voluntary recall of the unimplanted Nucleus CI500 cochlear implant range and is currently notifying healthcare professionals and regulatory authorities.

While less than 1% of CI512 implants have failed since launch in 2009, Cochlear has identified a recent increase in the number of Nucleus CI512 implant failures. In an abundance of caution Cochlear has issued a voluntary recall of the Nucleus CI500 range of cochlear implants while it further investigates the cause of this issue.

If failure occurs the implant safely shuts down without injuring the recipient. In the event of a Nucleus CI512 series implant failure recipients may be re-implanted with the Nucleus Freedom implant range which remains available.

All existing recipients with a Nucleus CI500 series implant can continue to use their system as normal.

The Nucleus CI500 implant range includes the Nucleus CI512 implant plus the following implants which are only available in limited markets – Nucleus CI513, Nucleus CI551 double array implant and Nucleus ABI 541 Auditory Brainstem Implant.

This voluntary recall does not affect any previous implant models including the Nucleus Freedom implant range which continues to be available.

The Nucleus 5 external devices (for example, Nucleus CP810) and any previous generation externals are not subject to this recall.

Our current priority is to ensure all cochlear implant healthcare professionals and recipients have the necessary information and support required.

The latest Nucleus 5 CP810 sound processor is fully compatible with Nucleus Freedom implants therefore recipients can continue to receive all the functionality the latest Nucleus 5 System offers through this combination.

Cochlear takes reliability extremely seriously and all necessary measures are being implemented to address this unexpected occurrence.

The financial impact of this recall is difficult to predict at this stage. Further information will be communicated when the situation becomes clearer.

-ends-

Company contacts:

Dr Chris Roberts, CEO/President p: + 61 2 9428 6555

Neville Mitchell, CFO p: + 61 2 9428 6572

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About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. It has a dedicated global team of more than 2,500 people who deliver the gift of sound to the hearing impaired in over 100 countries around the world. Our vision is to connect people, young and old, to a world of sound by offering life enhancing hearing solutions.

Over almost 30 years this vision has seen Cochlear help over 250,000 people either hear for the first time or reconnect them to their families, friends, workplaces and communities.

To this end, Cochlear offers solutions for different types of hearing loss. These include: cochlear implants, bone conduction implants, implants for electro-acoustic stimulation, auditory brain stem implants and implants for direct acoustic stimulation. Whether these hearing solutions were implanted 25 years ago or today, the company’s commitment to backward compatibility ensures new upgrades and innovations can be offered to Cochlear recipients.

Cochlear’s mission of “Hear now. And always” embodies the company’s commitment to providing its recipients with the best possible hearing performance today and for the rest of their lives.

www.cochlear.com

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