Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant. The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the […]
A federal appeals court last week overturned a win for Cochlear Ltd. (ASX:COH) in its patent spat with Advanced Bionics over hearing implant technology, sending the case back to district court for reconsideration in light of a recent U.S. Supreme Court decision. The cochlear implant patents were licensed to Advanced Bionics by the Alfred E. Mann Foundation, named […]
Alfred Mann, a medical device entrepreneur who helped develop several groundbreaking technologies, died yesterday at age 90, shortly after stepping down from a pair of companies he founded. Mann founded 17 companies over his 70-year career, in industries ranging from aerospace to medtech, according to the L.A. Times. After Johns Hopkins University researchers in 1969 […]
Sonova Holding AG‘s (SIX:SOON) subsidiary Advanced Bionics said today it launched its FDA and Health Canada cleared Naída CI Q90 sound processor in North America. The Q90 is the newest release from Advanced Bionic’s Naída line of cochlear implants, and offers the company’s smallest battery to date and new microphone technology that focuses on speech. […]
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."
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.
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.
— 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.