29
/de/
de
AIzaSyAYiBZKx7MnpbEhh9jyipgxe19OcubqV5w
April 1, 2024
Erstellen
Public Timelines
Bibliothek
FAQ
For education
Cabinet
For educational institutions
For teachers
For students/pupils
Herunterladen
Export
Eine Kopie erstellen
In der Webseite integrieren
Editieren
Einsichten 426
0
0
C.I. implants
Wurde erstellt
Max
⟶ Wurde aktualisiert 30 Sep 2017 ⟶
List of edits
Kommentare
Ereignisse
Melbourne & Nucleus Partnership
UCSF & Storz Partnership
3M 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 guidelines
Nucleus 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 difficulties
Perioden
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 rewards
3M & House Ear Institute partnership - Single Channel