On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2). The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores.
Timeframe: At 12- and 36-months post-activation (visit 9 and visit 11)
Safety outcome
Timeframe: From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)