C.I. implants
Category: Andere
Wurde aktualisiert: 30 Sep 2017
Autoren
Created byMax
Attachments
Ereignisse
Melbourne & Nucleus PartnershipUCSF & Storz Partnership3M Files for FDA Approval - Single Channel•FDA approval granted to 3M
•FDA Says multi-channel theoretically better•3M promotes 2nd Gen product
•3M Recalls all single channel C.I.
•FDA sets PMA guidelinesNucleus gets FDA approval•3M applies for FDA PMA on multi-channel
•FDA directs 3M to have 100 patients
•3M draws down on C.I. development, focus on hearing aids•New study indicates single channel might be viable option
•Market has already made up their mind•FDA & NIH jointly conclude multi-channel is the standard
•3M divests to Nucleus•3M attempts clinical trials on multi-channel device
•Hard to find patients
•Health Ins & otologists difficultiesPerioden
FDA approval process - 3M single channel•3M and UCSF partnership: Multi-Channel
•Ends due to differing academic and commercialization views•3M & Melbourne
•"Nationalistic reasons"•3M, with help from Nucleus, educate, train, and increase public literacy on C.I.
•"Free Riders" sit back and reap rewards3M & House Ear Institute partnership - Single Channel
Comments