Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery

• Conditions: Hearing Loss; Cochlear Microphonics; Electrocochleography; Cochlear Implant
• Interventions: Device: Cochlear implantation

• Registration Number: NCT05079867
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

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

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)

Study Timeline

• Study Start: 2021-07-19
• Status Verified: 2021-10
• Study First Submitted: 2021-10-03
• Study First Submitted QC: 2021-10-03
• Last Update Submitted: 2021-10-03
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-12-19
• Study Completion: 2023-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lateral wall (PL)	Cochlear implantation	Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode
Perimodiolar (PM)	Cochlear implantation	Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode

Primary Outcome Measures

Name	Time	Method
Amplitude of cochlear microphonics	0-12 months	Postoperative amplitude of cochlear microphonics

Secondary Outcome Measures

Name	Time	Method
Cochlear implant impedance	0-12 months	Postoperative value of cochlear implant impedance
Residual hearing	0-12 months	Average audiometric threshold

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Capital federal, Buenos Aires, Argentina