Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

Study Overview
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Brief Summary
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Prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (Day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

Detailed Description
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Branches: Perimodiolar (PM) Lateral wall (PL) Follow up schedule: Preoperative visit POV1 (up to 90 days before D0) Intraoperative visit D0 (Surgery - Day 0) Follow-up visit 1 FUV1 (48 hours) Follow-up visit 2 FUV2 14 days Follow-up visit 3 FUV3 (4 weeks) Follow-up visit 4 FUV4 (3 months) Follow-up visit 5 FUV5 (6 months) Follow-up visit 6 FUV6 (12 months)

Official Title
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Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery: Comparative Study Between Perimodiolar and Lateral Wall Electrodes

Conditions
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Hearing Loss, Cochlear Implant, Cochlear Microphonics, Electrocochleography

Intervention / Treatment
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* Device: Cochlear implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to receive a Cochlear implant 12 Months of age or older at the time of incorporation Willingness to participate and comply with the requirements of the protocol Residual hearing better than 80 dBA at 500 Hz Exclusion Criteria: Medical or pharmacological comorbid condition that contraindicates cochlear implantation. Previous implantation in the ear of the new implant Ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide Abnormal cochlear / neural anatomy on preoperative CT or MRI (excluding dilated vestibular aqueduct syndrome) Deafness due to lesions of the central auditory pathway. (Exclusion for evaluation of residual hearing) Diagnosis of Auditory Neuropathy Spectrum Disorder (Exclusion for evaluation of residual hearing) Active infection in the middle ear Chronic inflammatory processes in the middle ear Disabilities that could prevent participation in the evaluations Unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol. Surgical impossibility to follow the guidelines of the minimally traumatic technique.

Ages Eligible for Study
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Minimum Age: 12 Months

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perimodiolar (PM)<br>Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode | Device: Cochlear implantation<br>* Electrode surgically implanted in patient's cochlea to improve hearing<br>|
| Lateral wall (PL)<br>Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode | Device: Cochlear implantation<br>* Electrode surgically implanted in patient's cochlea to improve hearing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of cochlear microphonics | Postoperative amplitude of cochlear microphonics | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cochlear implant impedance | Postoperative value of cochlear implant impedance | 0-12 months | 
| Residual hearing | Average audiometric threshold | 0-12 months |