Advanced Bionics recall update

3 02 2011

Advanced Bionics have an update on the recall.

AB have identified the malfunctioning problem of two defective cochlear implants, which were giving shocks and pain to the users. Over 5,000 devices were voluntarily recalled by Advanced Bionics.

AB cochlear implants may be ready for dispatch and use by April 2011. However, the FDA process will hold up availability in the USA for some time. The new batch of cochlear implants will be manufactured with extra stringent electronic sheathing to avoid any possibility of short circuits.

Yay. Now more people have a good choice of cochlear implants available to choose from.

Go, Advanced Bionics!

With thanks to Zubair and Bob for their beady eyes and ears.

Story at Bloomberg

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9 responses

3 02 2011
Elaine

Actually if you read the story the FDA have said that nothing is final and it could be as far as Autumn.

Nothing is set in stone, yet!

3 02 2011
Funnyoldlife

Elaine. This is why I wrote ‘ … implants MAY be ready for dispatch …’
I did read the story. Plus, I have other sources.

3 02 2011
meghan

awesome! that’s great news!

16 02 2011
Researcher

Hi, I was wondering if you could help me? I am a researcher and I am looking to find out some more information about the AB recall and anyone in the UK who may have been affected by it?

17 02 2011
Funnyoldlife

@Researcher. Official information on the recall is on Advanced Bionic’s website at http://www.advancedbionics.com/cms/aboutab/media-center/press-releases.aspx. Plenty of people in the UK are on the waiting list for the next batch of AB implants which are planned to be released this year (in Europe), some have switched to another brand as they cannot wait, for various reasons. There are more opinions on Hearing Journey.
https://funnyoldlife.wordpress.com/2010/11/23/sonova-recall-advanced-bionics-cochlear-implant/

26 02 2011
Adam Fitzgerald

wish somebody had an idea of how long “Some Time” will be. I am one of those who has a certain date to wait till, then have to choose another company.

1 03 2011
Mark

“Researcher” sounds like a lawyer to me. 2 people were known to have a defective device, not a lot of stats in that for research. Big fan of AB.

4 03 2011
Funnyoldlife

The latest update ….

Sonova Says It’s Preparing to Bring Back Recalled Ear Implants

By Allison Connolly

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 serafino@bloomberg.net

8 03 2011

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