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Cochlear Americas

FDA approves Cochlear sound processor

July 6, 2020 By Sean Whooley

Cochlear Ltd. (ASX:COH) announced today that it received FDA approval for three new products in its suite of implantable hearing technology. Lone Tree, Colo.-based Cochlear won approval for its Nucleus Kanso 2 sound processor, Nucleus 7 sound processor for Nucleus 22 implant recipients and Custom Sound Pro fitting software, according to a news release. Cochlear touts […]

Filed Under: Food & Drug Administration (FDA), Implants, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: cochlear, Cochlear Americas, Cochlear Ltd., FDA

FDA approves new MR-safe hearing device from Cochlear

June 17, 2019 By Danielle Kirsh

Cochlear Ltd. (ASX:COH) today announced that it received FDA approval for its Cochlear Nucleus cochlear implant and its Nucleus 7 sound processor. The Nucleus Profile Plus implant is designed for safe use in MRI scans and offer easier access to 1.5 and 3.0 Tesla MRI scans without having to remove its internal magnet or use a […]

Filed Under: Blog Tagged With: cochlear, Cochlear Americas

Cochlear lands breakthrough FDA win for Nucleus Hybrid L24 hearing aid

March 20, 2014 By Arezu Sarvestani Leave a Comment

Cochlear lands breakthrough FDA win for Nucleus Hybrid L24 hearing aid

UPDATED March 21, 2013 with comments from Cochlear Americas president, principal investigator.

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Cochlear Americas, Cochlear Ltd., Hearing

Cochlear’s hearing implant lands a date with the FDA

October 25, 2013 By Arezu Sarvestani Leave a Comment

Cochlear lands a date with the FDA for hearing implant

Filed Under: Food & Drug Administration (FDA), Implants, News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Cochlear Americas, Cochlear Ltd., Hearing

Diabetes: Dexcom wins European approval for continuous glucose monitor | Regulatory Roundup

June 14, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Dexcom wins European approval for next-gen continuous glucose monitor

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Abiomed, Cochlear Americas, Dexcom, Hearing

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