Cochlear Implant, Cochlear Microphonics, Electrocochleography, Hearing Loss
Conditions
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)
Interventions
DEVICECochlear implantation
Electrode surgically implanted in patient's cochlea to improve hearing
Sponsors
Hospital Italiano de Buenos Aires
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude of cochlear microphonics | 0-12 months | Postoperative amplitude of cochlear microphonics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cochlear implant impedance | 0-12 months | Postoperative value of cochlear implant impedance |
| Residual hearing | 0-12 months | Average audiometric threshold |
Countries
Argentina
Contacts
Primary ContactFederico A Di Lella, MD PhD
Outcome results
None listed