Bloomberg News confirmed that Sonova Holding AG is working feverishly to fix the problems that spurred a global recall of the Advanced Bionics (AB)Hi-Res 90K cochlear implant and hopes to end the recall as early as April or at the latest by the autumn of this year.
Sonova CEO Valentin Chapero Rueda earlier this week indicated in an interview with the Swiss newspaper Handelszeitung that the AB cochlear implants could be back on the market by April, but a Sonova spokesperson clarified the projection in the subsequent Bloomberg story, saying “There’s also a likelihood it could be autumn. Nothing’s final.”
The severity of the problem that prompted Sonova’s voluntary recall-–the company disclosed that in two instances, “recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device”—has left the hearing industry wondering about the fate of Advanced Bionics, which Sonova Holding acquired a little more than a year ago.
As one of only three global cochlear implant makers, besides market leader Cochlear Ltd. of Australia and Med-El of Austria, a too-long absence from the market by California-based AB would threaten to reduce competition and slow the pace of innovation and expansion in the cochlear implant market — not to mention putting a dent in the finances of Sonova, parent of worldwide hearing aid market leader Phonak and other brands of hearing-aid and hearing-implant suppliers.
Dan Schwartz says
Advanced Bionics did not even submit their application to the FDA until May 20th; and they just announced they have requested a 135 day extension this week.
Also, soon after you posted this, Sonova CEO Valentin Chapero, CFO Oliver Walker, and Sonova Chairman and son of the founder Andy Rihs were arrested and charged with insider trading: Chapero & Walker were summarily dismissed by the Board; while Rihs took an inactive role on the Board,, in light of the accusations they sold stock when initial guidance was $60 million in losses; when in fact they were ready to release new guidance the losses would amount to over $200 million.
Then, on June 21st, the Sonova stockholders fired the entire board, including Rihs, who owns 9% of the $6 billion Swiss conglomorate:
http://www.bloomberg.com/news/2011-06-21/sonova-shareholders-discharge-board-amid-trading-probe-awp-says.html
Dan Schwartz,
Editor, The Hearing Blog
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Dan Schwartz says
The problem is that the FDA has a real hard-on for AB, as this is their fifth recall in less than a decade; and also that Sonova is their second buyer, after the “marriage and divorce” from Boston Scientific.
What’s more, until they fix the feedthru problem once and for all, they haven’t fixed the problem. Please see these two articles in The Hearing Blog I wrote about this:
Failing Ugly: Advanced Bionics cochlear implant circuit goes haywire
http://thehearingblog.com/archives/54
Failing Ugly II: More on the Advanced Bionics Recall
http://thehearingblog.com/archives/65
Dan Schwartz,
Editor, The Hearing Blog