Sonova Says It’s Preparing to Bring Back Recalled Ear Implants
Sonova Holding AG is preparing to reintroduce the HiRes 90K hearing implants, possibly as soon as April, following a recall last year, a company spokesman said.
The company voluntarily recalled the HiRes 90K hearing implant worldwide in November after a malfunction led to “severe pain, overly loud sounds and/or shocking sensations” in two cases.
“We know the problem; we know how it can be solved,” the spokesman, Holger Schimanke, said in an interview today. “It could be April. There’s also a likelihood it could be autumn. Nothing’s final.”
The U.S. Food and Drug Administration will decide when sales can resume there, and the Staefa, Switzerland-based company has no clear time frame for when that could happen, Schimanke said. The implants, made by its Advanced Bionics unit, may become available outside of the U.S. sooner, he said.
In an interview with Handelszeitung published today, Sonova Chief Executive Officer Valentin Chapero Rueda said the chances that the reintroduction of the product in some markets will be delayed until the second half of the year are "increasingly less."
“It can be that we are already back on the market in April,” Rueda said in the interview.
Sonova rose as much as 5 percent, the biggest intraday gain since Oct. 14, following the CEO’s comments. The stock gained 4.70 francs, or 4 percent, to 123.30 francs at 12:34 p.m. in Zurich trading.
To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net.
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net.
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