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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.
Branches:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perimodiolar (PM) | Patients to be implanted with: Mid Scala or CI532 / 632 (Slim modiolar) electrode |
| |
| Lateral wall (PL) | Patients to be implanted with: Slim J or CI522 / 622 (Slim Lateral) electrode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implantation | Device | Electrode surgically implanted in patient's cochlea to improve hearing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of cochlear microphonics | Postoperative amplitude of cochlear microphonics | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cochlear implant impedance | Postoperative value of cochlear implant impedance | 0-12 months |
| Residual hearing | Average audiometric threshold |
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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.
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All patients over 12 months of age who will receive a cochlear implant
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico A Di Lella, MD PhD | Contact | +5411 49590200 | 9490 | federico.dilella@hospitalitaliano.org.ar |
| Name | Affiliation | Role |
|---|---|---|
| Federico A Di Lella, MD PhD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Recruiting | Capital Federal | Buenos Aires | C1199ABB | Argentina |
There is no plan to share IPD to other researchers.
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D019929 | Cochlear Implantation |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
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| 0-12 months |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |