Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
PACIFIC
1 other identifier
observational
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
March 28, 2024
March 1, 2024
1.4 years
October 13, 2021
March 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
At 12- and 36-months post-activation (visit 9 and visit 11)
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.
From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation)
Secondary Outcomes (12)
Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores.
At 12- and 36-months post-activation (visit 9 & visit 12)
Stability of outcomes over time using AzBio Sentence scores at 1 month in Quiet.
At 1 month post-activation (Visit 6)
Stability of outcomes over time using AzBio sentences in Quiet and Noise at 3- ; 6- and 24-months post-activation
at 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
Stability of outcomes over time using CNC word scores at 3-, 6- and 24-months
At 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11)
Stability of outcomes over time for patients under a bimodal condition (i.e., patient wearing a contralateral hearing aid).
At 3-months post activation (visit 7) and 12 months (visit 9)
- +7 more secondary outcomes
Interventions
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
Eligibility Criteria
* 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
You may qualify if:
- 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 \_
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
December 13, 2021
Study Start
September 1, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2029
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share