Dexamethasone-Eluting Cochlear Implant Electrode

Study Overview
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Brief Summary
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A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain a first experience in use of the investigational device in the adult clinical population, and to initially assess tools, techniques and performance outcome measures that may be considered in future clinical studies of similar devices.

Detailed Description
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The principal objective of this study is to exploratively investigate the safety profile of the device which will be evaluated through the analysis of adverse events during the follow-up period. For the study to be considered a success, the results of the adverse event analysis shall never cause an unbalanced risk vs. benefit assessment. The secondary objectives of this study aim at investigating the usefulness of possible outcome measures in evaluating the performance of the device.

Official Title
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Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study

Conditions
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Hearing Loss, Sensorineural, Sensorineural Hearing Loss

Intervention / Treatment
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* Device: CIDEXEL implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of eighteen (18) years at time of enrolment. Severe to profound sensorineural hearing loss on the ipsilateral ear. A functional auditory nerve in the ear to be implanted. Subjects reporting to having used an optimally fit hearing aids for a minimum of three months before the decision that a cochlear implant (CI) is the preferential option. Cochlea anatomy compatible with the insertion of a +FLEX28 electrode array. Compatibility with a soft surgery approach as per clinical practice at the site. Post-lingual hearing impairment. Subject fulfilling indication criteria for a CI according to the local professional standards, as reported by the implanting surgeon. General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon. Signed and dated informed consent before the start of any study-specific procedure. Exclusion Criteria: Lack of compliance with any inclusion criterion. Previously having received a cochlear implant on the ear chosen for placing the IMD (Investigational Medical Device). Evidence of ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or might cause increased risk of infection (e.g. dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT (Computed Tomography/Magnetic Resonance Tomography). Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull. Evidence of otosclerosis. Known allergic reaction or intolerance to the materials used in the implant (including medical grade silicone, platinum, iridium, parylene c, dexamethasone). Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway. Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted. Evidence of perforated tympanic membrane in the ear to be implanted. Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks before enrolment. Evidence of concomitant use of medicinal substances that, in the opinion of the investigator, could alter the therapeutic efficacy of dexamethasone. Unwillingness or inability of the candidate to comply with all investigational requirements. Evidence of medical contraindications to surgery of the middle and inner ear and anaesthesia. Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation.

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm - treatment<br>All subjects will be implanted with the investigational device. | Device: CIDEXEL implant<br>* The newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Safety profile of the device which will be evaluated through the analysis of adverse events | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IFT (Impedance Field Telemetry) - impedance | Impedance Field Telemetry and derived values | 10 months | 
| Electrically Evoked Compound Action Potential | Electrically Evoked Compound Action Potential and derived values | 10 months | 
| MCL (Maximum Comfortable Loudness) | Maximum Comfortable Loudness Levels and Thresholds | 10 months | 
| THR (Threshold) | Thresholds | 10 months | 
| PTA (Pure Tone Audiometry) Audiometrical values | Results from PTA assessment | 10 months | 
| Hearing Preservation rate | Rate of Hearing Preservation according to Skarżyński et al. | 10 months | 
| HSM (Hochmair-Schulz-Moser Sentence) Test | Speech test in noise | 10 months | 
| Questionnaire | Surgical feedback questionnaire | 10 months |