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.
Individuals 18 years of age or older
Obtain limited benefit from appropriately fitted hearing aids
Bilateral severe-to-profound sensorineural hearing loss _ Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on a validated sentence recognition test in quiet (AzBio sentences), in the best-aided listening condition _
Previous cochlear implantation
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
Active external or middle ear infections or tympanic membrane perforation in the ear to be implanted
Presence of medical contraindications to middle-ear or inner-ear surgery or anesthesia as required
* The current post-approval study concerning the NCIS will enroll a total of 60 subjects, newly treated. Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose. * 60 subjects must meet the eligibility criteria * The patient can be an existing audiology patient of the CI clinic or can be referred from an outside hearing aid clinic
Cohort
Prospective
Neuro Cochlear Implant system
DevicePatients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose
Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores.
Average scores for AzBio sentence tests will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores.
Safety outcome
Occurrence and severity of all adverse events and serious adverse events occuring during the study period. All device failures (internal and external parts) will be documented.
Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores.
Consonant-Nucleus-Consonant (CNC) scores will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Stability of outcomes over time using AzBio Sentence scores at 1 month in Quiet.
Scores for AzBio sentence tests will be recorded in Quiet at 1-month post-activation in quiet and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores.
Stability of outcomes over time using AzBio sentences in Quiet and Noise at 3- ; 6- and 24-months post-activation
Average scores for AzBio sentence tests will be recorded in Quiet at 3- ; 6- and 24-months post-activation and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test and has a score range of 0-100% with higher values indicating better scores.
Stability of outcomes over time using CNC word scores at 3-, 6- and 24-months
Average scores for CNC word test will be recorded at 3-, 6- and 24 months post-activation and compared to pre-operative (baseline) measures. The Consonant-Nucleus-Consonant (CNC) word test has a score range of 0-100% with higher values indicating better scores.
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