Advanced Bionics back on the market in the US

Advanced Bionics Announces FDA Approval For U.S. Market Re-Entry Of The HiRes 90K Cochlear Implant

-- Distribution of HiRes 90K Cochlear Implants in the United States Now Under Way --

VALENCIA, Calif., September 13, 2011 – Advanced Bionics (AB), the only U.S.-based manufacturer of cochlear implants and a subsidiary of Switzerland-based Sonova, announced today the approval of the FDA for immediate market re-entry of the HiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics received approval from several other 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.

“Everyone at AB and Sonova is excited that we are back on the market globally. We stand by our commitment to putting patients first and delivering high-quality products for the best possible hearing experience,” said Hansjuerg Emch, Group Vice President Medical of the Sonova Group. “The support we have received across the industry for our integrity has been incredible.”

AB’s first priority is the safety and well-being of patients, which is why it instituted a voluntary recall in November 2010 after becoming aware of a rare issue with the HiRes 90K cochlear implant. Of the more than 28,000 implanted HiRes 90K devices, only two (0.007%) explanted devices were confirmed to have this issue. In the months since the recall was instituted, AB implemented changes to its manufacturing process to ensure that there is no effect on the safety or efficacy of the HiRes 90K cochlear implant.

While off the market, AB actively continued all research and development projects that were under way prior to the recall.

“Our upcoming launches and products currently in development will continue to lead the industry and help our patients hear their best and live a fulfilled life,” said Dr. Gerhard Roehrlein, CEO and CTO of Advanced Bionics, LLC.

About Advanced Bionics

Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Founded in 1993 and working with Phonak under the Sonova Group since 2009,

AB develops cutting-edge cochlear implant technology that restores hearing to the deaf and allows recipients to hear their best.

With sales in over 50 countries and a proven track record for developing high-performing, state- of-the-art products, AB’s talented group of technologists and professionals from all over the world are driven to succeed, work with integrity and stay firmly committed to quality.

To learn more about AB and its revolutionary cochlear implant technology, please visitwww.advancedbionics.com.

Media Contact:

Cheryl Garma

Advanced Bionics, LLC

661.362.1400

MediaInquiries@AdvancedBionics.com

Voluntary Recall Notification for Nucleus CI500 cochlear implant range

Voluntary Recall Notification for Nucleus CI500 cochlear implant range

Cochlear Limited is undertaking a voluntary recall of the unimplanted Cochlear Nucleus CI500 cochlear implant range.
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 and with our recipients in mind, Cochlear has issued a voluntary recall of the Nucleus CI500 range of cochlear implants while it further investigates the issue.
No implants outside the Cochlear Nucleus CI500 range are affected by this voluntary recall including Nucleus Freedom implants which remain available.
The Nucleus 5 external devices (Nucleus CP810 Sound Processor) and any previous generation sound processors are not affected by this recall.
It is important to note that all existing Nucleus CI512 implant recipients can continue to use their system as normal.
If a Nucleus CI512 failure occurs, the implant safely shuts down.  In the event of a failure, recipients can be re-implanted with the Nucleus Freedom implant range which remains available.  Nucleus Freedom is fully compatible with the Nucleus 5 Sound Processor System which is not affected by this recall.
For people considering a cochlear implant, Cochlear recommends the use of the Nucleus Freedom range of Cochlear implants which are fully compatible with the Nucleus 5 sound processor system.  This combination of Nucleus Freedom and Nucleus 5 sound processor system does not sacrifice any of the performance benefits of the Nucleus 5 processor system.
For more than 25 years, cochlear implant reliability has been of paramount importance to Cochlear, and we remain committed to providing high quality, high reliable cochlear implant systems.
We sincerely apologise for any concern this causes.  I f you have any questions regarding this please do not hesitate in contacting your local Cochlear office.

Cochlear shares plummet on product recall

Cochlear shares plummet on product recall

Eli Greenblat

September 12, 2011 - 10:29AM

Shares in bionic ear implant company Cochlear fell 17 per cent in early trade after the global leader in hearing technology announced a voluntary recall of its unimplanted CI500 Cochlear range.

Shares were down as much as $19.41, or 27 per cent, to $52.77. They were recently 18 per cent lower at $60.00.

The Sydney-based company said in an announcement to the Australian Stock Exchange that it had begun notifying healthcare professionals and regulatory authorities about the recall.

Cochlear said the financial impact of the recall was difficult to forecast at this stage.

Cochlear said in its announcement that all existing recipients with a Nucleus C1500 series implant can continue to use their system as normal.

Cochlear said less than 1 per cent of CI512 implants had failed since its launch in 2009, but that it had identified a recent increase in the number of Nucleus CI512 implant failures.

To be cautious the company had decided to recall the Nucleus CI500 range of implants while it investigates the cause of the problem.

Cochlear has implanted its bionic ear device in more than 250,000 people over the past 30 years and the company has managed to dodge the types of problems that have led many of its competitors to recall their own devices due to health-related problems linked to the devices.

Over the past 10 years its key rivals in the United States were forced onto the sidelines due to problems with their own devices, handing Cochlear a clear run to capture a bulk of the North American market. The last time a rival of Cochlear was forced out of the market the Australian company boosted its market share well above 75 per cent.

The affected 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.

Its Nucleus 5 external device range and any other previous generation externals are not subject to this recall.
More than 10 years ago Cochlear was the target of a US Department of Justice investigation into payments made to physicians and providers. No charges were ever brought against Cochlear or any of its executives.

The company recently unveiled a full-year profit of $180.11 million, up 16 per cent, as revenue increased 10 per cent to $809.6 million.

Continued technological innovation has helped Cochlear maintain its dominant market share in the implant industry, with its Nucleus range of implants touted as the next generation series of devices that would help Cochlear stay ahead of its competitors as well as encouraging greater take-up rates among doctors and patients.

egreenblat@theage.com.au