Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery (NCT05079867) | Clinical Trial Compass
UnknownNot Applicable
Cochlear Trauma, Functional and Structural Preservation in Cochlear Implant Surgery
Argentina40 participantsStarted 2021-07-19
Plain-language 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.
Who can participate
Age range12 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.