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Advanced Bionics Recalls Certain Cochlear Implant Devices

advancedbionics feb19 lt

Advanced Bionics LLC, the US unit of Swiss hearing aid maker Sonova Holding AG, has recalled certain un-implanted cochlear implant devices due to decreased hearing performance. The recall would incur costs in the range of 40 million Swiss francs to 50 million francs.

In a statement, Sonova said that Advanced Bionics or AB has notified relevant regulatory bodies that it will retrieve un-implanted devices of the initial version of HiRes Ultra and Ultra 3D cochlear implant devices. They will be replaced with the new version of the device, which has received regulatory approvals in major markets.

The move comes after reports of recent increases in the number of explants of devices, related to lower impedances and reports of decreased hearing performance of a limited number of cochlear implant devices.

The company claims that less than 0.5% of recipients have been explanted till date, and that the vast majority of HiRes Ultra and Ultra 3D implants continue to function properly. This situation does not present a device related safety issue to the recipients, the company noted.

AB's voluntary field corrective action is expected to temporarily affect its sales and earnings development during the deployment of the new version.

AB in 2010 had recalled certain cochlear implant devices following 2 cases of malfunction requiring explantation.

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