Advanced Bionics LLC
Cochlear Ltd. wins reprieve in $131m patent loss to Advanced Bionics
China approves Advanced Bionics’ ‘swimmable’ hearing aid
California-based Advanced Bionics announced last week that it won approval in China for its Neptune hearing aid, which the company calls "the world’s 1st and only swimmable, waterproof cochlear implant sound processor."
Jury slaps Cochlear Ltd. with $131M infringement verdict
Jury hits Advanced Bionics with $7M judgment over recalled HiRes 90k cochlear implant
A federal jury awarded a Kentucky couple more than $7.2 million, including nearly $6.3 million in punitive damages, over the failure of their daughter’s Advanced Bionics’ recalled HiRes 90k cochlear implant.
The jury in the lawsuit, filed in the U.S. District Court for Western Kentucky, found that Advanced Bionics didn’t properly test the implant before it hit the market and never told the FDA that it had switched the manufacturer of a key component to a vendor called AstroSeal.
Advanced Bionics hearing implant back on the market | Regulatory Roundup
After nearly a year, Sonova Holding AG (SIX:SOON) subsidary Advanced Bionics was allowed back in the U.S. market with its HiRes 90K cochlear implant.
In the past few months, Advanced Bionics received approval to resume distribution in Canada and countries accepting the CE Mark.
Advanced Bionics Announces FDA Approval for U.S. Market Re-Entry of the HiRes 90K Cochlear Implant
— Distribution of HiRes 90K Cochlear Implants in the United States Now Under Way —
VALENCIA, Calif., Sept. 13, 2011 /PRNewswire/ — Advanced Bionics (AB), the only U.S.-based manufacturer of cochlear implants and a subsidiary of Switzerland-based Sonova, announced today the approval of the FDA for immediate market re-entry of the HiRes 90K cochlear implant in the United States. In recent months, Advanced Bionics received approval from several other regulatory agencies, including Health Canada and the European Notified Body, TUV, to resume distribution of the HiRes 90K implant to Canada and countries accepting the CE Mark.
Advanced Bionics recalls hearing implant
Advanced Bionics recalled its cochlear hearing-aid implants.
The subsidiary of Staefa, Switzerland-based Sonova Holding AG (SIX:SOON) received reports that is HiRes 90K cochlear implant device had malfunctioned eight to 10 days after it was activated. Two patients suffered from pain and loud noise, according to the company.
Advanced Bionics notified the Food & Drug Administration of the problem and its working with the agency to rectify it.