Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device worldwide.The device will be removed from the market as a precaution while the company works with the US Food & Drug Administration to address the issue.
This action is being taken in response to two instances thus far where the product experienced a rare malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations, at 8-10 days after initial activation of their device. AB is working closely with the FDA to identify the problem and institute changes to the product to ensure that the HiRes 90K has the highest quality for patients who use the device. This voluntary action is being taken as a precaution and the risk of adverse medical events is remote at present. A notification letter from the company to cochlear implant professionals and recipients is forthcoming.
Outlook for the remainder of the year
It is still too premature for the Sonova Group to predict the impact the recall will have on sales and operating income for the remainder of the fiscal year 2010/11 for Advanced Bionics. As soon as the Sonova Group is able to ascertain the fiscal impact of the recall, it will communicate this information.
Disclaimer
This Media Release may contain forward-looking statements which offer no guarantee with regard to future performance. These statements are made on the basis of management's views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside the company's control.
About Sonova
Sonova is the leading provider of innovative hearing healthcare solutions. The globally active Group is the world's top manufacturer of hearing instruments, the market leader in wireless communication systems for audiology applications, develops and manufactures advanced cochlear implant systems and provides professional solutions for hearing protection. Sonova is pursuing a clear growth strategy and is intent to grow faster than the market. To this end, it is constantly expanding its business segments and branching out into other areas of the hearing healthcare industry.
Present in over 90 countries, and with a workforce of over 6,800 employees, Sonova generated sales of CHF 1.5 billion in the financial year 2009/10 and a net profit of CHF 355 million. This financially strong group of companies bases its success on innovation, customer focus and proactive cost management.
The company has been successfully promoting understanding and communication for over 60 years, and is ideally positioned to benefit from the trends in this growth industry.
For more information please visit www.sonova.com.
Sonova
shares (ticker symbol: SOON) have been listed on the SIX Swiss Exchange
since 1994.
Contacts:
Sonova
Director Investor & Corporate Relations
Dr. Holger
Schimanke, +41 58 928 33 44
holger.schimanke@sonova.com
or
Manager
Investor & Corporate Relations
Gina Francioli, +41 58 928 33 47
gina.francioli@sonova.com
