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Home » FDA approves Cochlear Nucleus Implant for unilateral hearing loss, single-sided deafness

FDA approves Cochlear Nucleus Implant for unilateral hearing loss, single-sided deafness

January 11, 2022 By Danielle Kirsh

cochlear's nucleus systemCochlear Ltd. (ASX:COH) today announced that it received FDA approval for extended applications of its Nucleus implants.

Sydney, Australia-based Cochlear designed the Nucleus implants to treat unilateral hearing loss (UHL) and single-sided deafness (SSD). The implants were already FDA approved for those with moderate to profound bilateral sensorineural hearing loss.

UHL is characterized by hearing loss in one ear and near to near-normal hearing in the opposite ear. SSD is experienced by people with severe to profound hearing loss in one ear and normal or near-normal hearing in the other ear, according to Cochlear.

“It is not often that approvals to expand indications and increase awareness about effective treatments for hearing loss come along. Now with this approval, Cochlear is proud to offer the most hearing implant options available to those with unilateral hearing loss/single-sided deafness through our cochlear implant and bone conduction solutions,” Christine Menapace, VP of clinical affairs at Cochlear Americas, said in a news release.

Filed Under: Food & Drug Administration (FDA), Implants, Otolaryngology/Ear, Nose & Throat (ENT), Pre-Market Approval (PMA) Tagged With: cochlear

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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