Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant Sy… (NCT05154188) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
60 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 \_
Exclusion Criteria:
* 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
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
Safety outcome
Timeframe: From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)