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Media Release :
Place, Date St?fa (Switzerland), April 14, 2011 r63
Editor Alexander Zschokke (acting CEO) and Paul Thompson (acting CFO)
Page 1 of 2
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 Alexander 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
媒体发布
地点，时间：Stäfa (新西兰), 2011年4月14日
作者：Alexander Zschokke (临时CEO)和Paul Thompson (acting CFO)
第1页，共2页
Sonova宣布Advanced Bionic’s人工耳蜗重新进入欧洲、亚太和拉丁美洲市场
听力系统辅助设备的重要供应商Sonova Holding AG今天宣布AB人工耳蜗公司提交的（世界领先的人工耳蜗植入装置）Hires90K植入体的制造改变，获得欧洲认证组织CE认证。AB正在启动将已经重新获准CE认证的Hires90K植入体进行重新生产，并在认可CE认证的市场及不需要申请注册的市场进行配售。
在2010年11月23日宣布自愿召回HiRes 90K™植入体之前，AB公司在上述市场的销售额占其全球市场的70%。Sonova希望AB在最近的几周内恢复在上述国家和地区的正常业务。
此外，AB计划在未来的几周内向美国食品药品监督局（FDA）提交其植入体制造方面的改变。
Sonova 集团的总裁Alexander Zschokke说：“获得欧洲CE认证是AB恢复其业务的重要里程碑，我相信，作为人工耳蜗植入领域的领导者，AB可以很快挽回它的市场”
本着患者至上和以植入者的安全为原则，在技术缺陷出现率极低的情况下，AB决定在2010年11月自愿召回HiRes 90K 人工耳蜗植入体。AB的调查显示，在28,000套植入设备中，仅2套设备确定存在技术问题。AB在2011年1月总结了此次事故的根部原因分析。此后，AB改进了制造工艺，以保证不会再出现类似的缺陷。
Sonova将于2011年5月24日在其2011/2012年度会议中公布AB重回市场的财务影响预期。 |
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发表于 2011-5-9 17:58
