Cochlear-implant maker lifts recall

From: Los Angeles Daily News - Los Angeles,CA,USA - Nov 9, 2004

By Eugene Tong Staff Writer

VALENCIA, Advanced Bionics Corp., a local medical-implant manufacturer, has lifted a voluntary recall and resumed distribution of a hearing-aid system, officials said Tuesday.

The company pulled its HiResolution cochlear implant in late September to account for changes in the manufacturing process, spokesman Doug Lynch said.

"We wanted to validate some of those changes to make sure they did what they were supposed to do," he said. "The process of manufacturing includes continuous revisions, sometimes very minor, to improve the reliability of the device."

Only unimplanted devices were recalled. About 2,600 have been manufactured since the model was introduced about a year ago.

"No patients were affected," Lynch said.

Cochlear implants are used to treat adults with severe or profound bilateral hearing loss. More than 16,000 adults and children use the company's cochlear implants, which produce an electrical reproduction of acoustic signals through a proprietary processing technology.

The Valencia-based company was acquired in June by medical device maker Boston Scientific.

Eugene Tong, (661) 257-5253 eugene.tong@dailynews.com

Copyright 2004 Los Angeles Daily News
Los Angeles Newspaper Group