STÄFA, Switzerland--(BUSINESS WIRE)--Regulatory News:
Sonova Holding AG (SIX:SOON), the world’s leading provider of hearing systems, is announcing today, that Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, has received CE mark approval from the European Notified Body (TÜV) for changes submitted for the manufacturing of the HiRes 90K™ implant. Advanced Bionics is in the process of resuming production and distribution of HiRes 90K implants in all markets that recognize the CE mark or do not require additional approval.
Prior to the voluntary recall of HiRes 90K™ announced on November 23, 2010, AB generated approx. 70% of its global sales in these markets. Sonova expects Advanced Bionics to resume its business in these countries over the next few weeks.
In addition, AB intends to submit the necessary documentation on the changes to the manufacturing process to the United States Food and Drug Administration (FDA) in the coming weeks.
“The CE mark approval is an important milestone for Advanced Bionics to resume its global business activities,” said Alexander Zschokke, acting CEO of the Sonova Group. “ I am fully confident, that AB will regain its market position as one of the leading cochlear implant manufacturers very soon.”
As part of AB’s commitment to putting patients first and protecting the safety of its implant recipients, Advanced Bionics instituted a voluntary recall of the HiRes 90K cochlear implant in November 2010 as a result of a very rare technical defect. AB’s investigation continues to show that of the more than 28,000 implanted HiRes 90K devices, only two devices have been confirmed to have a technical issue. AB concluded the root cause analysis in January 2011. Since that time, AB has implemented changes to the manufacturing process to ensure that no further implants will have this defect.
Sonova will update its expectation of the financial impact of the resumed business activities of AB at its full year guidance 2011/12 on May 24, 2011.
Disclaimer
This ad hoc publication notice 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 systems and market leader in wireless communication systems for audiology applications. It develops and manufactures advanced cochlear implant systems and provides professional solutions for hearing protection. Sonova is pursuing a clear growth strategy and is intent on growing faster than the market. To this end it is constantly expanding its existing 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. The securities of Sonova have not been and will not be registered under the U.S. Securities Act and may not be offered or sold in the United States of America except pursuant to an exemption from the registration requirements under the U.S. Securities Act, or outside the United States of America in reliance on Regulation S under the U.S. Securities Act.