Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
NCT ID: NCT05154188
Last Updated: 2024-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2025-09-01
2029-02-28
Brief Summary
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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.
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Detailed Description
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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. This study will be conducted as a prospective, non-controlled, non-randomized study in 10 clinical sites.
A total of 60 subjects, newly treated will be enrolled. Study subjects will be followed for 3 years post implantation of the device with a target follow-up rate of 80% at the end of the study
The primary safety endpoint is the comparison of the type and frequency of adverse events and serious adverse events observed during the study period. The effectiveness endpoints will include the within-subject differences for sentence recognition as evaluated with the AzBio test.
The study will include the following visits: baseline, 1-month post-surgery (activation date), 3 months, 6-months, 12-months, 18-months, 24-months, and 36-months post-activation. Each participant will serve as their own control with baseline measurements.
The total estimated duration of the study is 60 months: 24 months of recruitment and 36 months of subject participation.
The first patient is expected to be included within 6 months of study approval (obtained on August 19, 2021).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Neuro Cochlear Implant system
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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CIP25
Identifier Type: -
Identifier Source: org_study_id
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