Advanced Bionics HiRes 90K Implant Returns to European, Other Markets

[Guest guest]

Press release, Sonova - April 14, 2011

-----------

Sonova announces the return of Advanced Bionic’s cochlear implant business

to the European, Asia Pacific, and Latin American Markets

Sonova Holding AG, 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 Zschokke, acting CEO

of the Sonova Group. “ I am 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.