Cochlear Implant With Dexamethasone Eluting Electrode Array

Study Overview
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Brief Summary
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An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Detailed Description
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The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

Official Title
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Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

Conditions
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Sensorineural Hearing Loss, Bilateral Hearing Loss

Intervention / Treatment
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* Device: CI632D
* Device: CI632


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL. 18 years or older at time of consent. Exclusion Criteria: Abnormal cochlear and middle ear anatomy History with cochlear implant surgery Allergy to dexamethasone Women who are pregnant or plan to become pregnant Unable/unwilling to comply to study 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CI632D Investigational Medical Device (IMD)<br> | Device: CI632D<br>* CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)<br>|
| Placebo Comparator: CI632 Comparator Device<br> | Device: CI632<br>* CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits. |  | Six months | 
| Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits. |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of rate and type of device related adverse events between randomisation groups. |  | Six months and twelve months | 
| Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit. |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear Implant, Dexamethasone, Bilateral Hearing Loss, Sensorineural Hearing Loss