The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.

Detailed Description
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Appropriate adult cochlear implant candidates with sensorineural hearing loss, from English French Canadian centres and Danish centre, received Neuro Zti cochlear implant and fit with Neuro One sound processor. Speech perception testing, using HINT (Hearing In Noise Test) sentences in quiet (65 dB SPL) (decibel, Sound Pressure Level) and in noise (+10 dB SNR) (decibel, Signal-to-Noise-Ratio), will be administrated pre-operatively in the best listening conditions and 3, 6, and 12 months post-activation in the implanted ear. Adverse events will be collected during the surgery and over the post-surgical period from activation to12 months post-activation. Safety will be assessed on the overall English, French and Danish participants. Efficacy will be assessed on English speaking participants.

Official Title
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The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults

Conditions
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Hearing Loss, Cochlear, Hearing Loss, Sensorineural, Deafness

Intervention / Treatment
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* Device: Neuro Zti
* Device: Neuro One


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adults, eighteen (18) years of age or older. Bilateral severe-to-profound sensorineural hearing loss, defined by pure-tone average (PTA) ≥70 dB HL (Hearing Level) at 500, 1000 and 2000 Hz on both ears. HINT sentences recognition scores in quiet ≤ 50% correct, in the best-aided listening condition. Post-lingual onset of deafness. Primary implantation (no re-implantation). Up-to-date pneumococcal vaccine. Exclusion criteria Medical conditions that contraindicate undergoing cochlear implant surgery (middle ear diseases i.e. AOM/CSOM (Acute Otitis Media/Chronic Suppurative Otitis Media) , lesions of auditory nerve, pathologies of central auditory pathway, otosclerosis; cochlear malformation i.e. Mondini malformation, cochlear ossification, large vestibular aqueduct). Unrealistic expectations regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and medical device. Unwillingness or inability of the candidate to comply with all investigational requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuro Cochlear Implant System study group<br>All patients will receive a Neuro Zti implant and fitted with Neuro One sound processor | Device: Neuro Zti<br>* Cochlear implant<br>Device: Neuro One<br>* Sound processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants. | To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet at 6 months pos-activation in English speaking participants. Primary clinical efficiency outcome is defined as the change in HINT scores from baseline to 6 months post-activation. Recorded HINT sentences lists were presented to the participant at 60 dB SPL (sound pressure level) pre-operatively in the best aided hearing conditions and at 6 months in the implanted ear after Neuro Zti implant activation. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. Change = (6 Months score - Baseline score). A score greater or equal to 10% was considered clinically significant improvement. | pre-operative, 6 Months | 
| Major Related Adverse Event (AE) | Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause. AEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure. AEs were classified as Major if they corresponded to any of the following criteria: life-threatening conditions (e.g. meningitis) require hospitalization result in permanent disability or damage (e.g. facial nerve paresis) require revision surgery with or without explantation or re-implantation (e.g. device failure, flap necrosis) medical events that could not be alleviated by electrode deactivation (e.g. tinnitus, facial nerve stimulation, pain) The co-primary safety endpoint is the major related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit on English-speaking Participants | Clinical benefit is defined as the change of HINT scores post-operatively in the implanted ear only with masked contralateral ear and pre-operatively in the best aided conditions. Clinical benefit is measured in quiet and in noise using the Hearing in Noise Test (HINT). In quiet, HINT sentences lists were presented to the participant at 60 decibel sound pressure level (dB SPL). In noise, the sentences were presented with concurrent background noise at +10 decibel signal-to-noise-ratio (dB SNR), signal level at 65 dB SPL and noise at 55 dB SPL. Resultant score is a percentage of words correctly repeated, possibly ranged from 0% to 100%. Clinical benefit is computed for each participant. A positive difference of post- and pre-operative HINT scores is considered clinically significant if it exceeded 10 percentage points (pp). A decrease that exceeded 10 pp is considered a clinically significant decrement. A difference of less than 10 pp was considered as no change in performance. | 3, 6 and 12 months | 
| Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants | To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants. Secondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation. Recorded HINT sentences lists were presented to the participant at 60 dB SPL pre-operatively in the best aided hearing conditions, at -, 6- and 12- months. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. A higher score is better. | pre-operative, 3, 6 and 12 Months | 
| Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants | To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in noise pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants. Secondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation. Testing open-set sentence recognition with concurrent background noise present at +10 decibel signal-to-ratio (dB SNR) with signal level presented at 65 dB SPL and noise at 55 dB SPL. Recorded HINT sentences lists were presented to the participant in front pre-operatively in the best aided condition and post-operatively in the implanted ear alone with masked contralateral ear. Speech and noise were colocated (S0N0). Resultant score is a percentage of words correct. Possible scores range from 0% to 100% words correctly repeated. A higher score is better. | pre-operative, 3-, 6- and 12-Months | 
| Minor Adverse Events (AE) | Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause. AEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure. AEs were classified as Minor if they corresponded to any of the following criteria: adverse event settled spontaneously without surgical procedure (e.g. hematoma) adverse event settled spontaneously with conservative medical management The secondary safety endpoint is the minor related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otorhinolaryngology, Oticon Medical, Neuro Cochlear Implant System, Hearing Loss, Cochlear Implant surgery