Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery
Sensorineural Hearing Loss, Cochlear Implant
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring corticosteroids, Electric impedance
Eligibility Criteria
Inclusion Criteria:
- Patients who are candidates to receive a uni or bilateral cochlear implant with diagnosis of severe neurosensory hearing loss.
- Ages between 12 months and 85 years.
- Evaluation of internal ear anatomy performed by tomography and resonance magnetic, where normal cochlea and internal auditory canals are evidenced normal.
- Patients in which any implant of the Cochlear company is used: CI512, CI522 or CI532 with chipset CIC4 or higher.
- Complete insertion of electrodes through round window, round window enlarged or cochleostomy, via posterior tympanotomy using the technique universally known as "minimally traumatic surgery"
Exclusion Criteria:
- Refusal to participate in the protocol or to informed consent
- Intra-surgical gusher (see below, section "definitions").
- Contraindication to receive dexamethasone
- Medical, imaging, psychological or social contraindications to receive a cochlear implant
- Surgical or anesthetic contraindications for cochlear implant surgery.
Sites / Locations
- HIBARecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DEX
SF
Topical dexamethasone will be placed at a concentration of 20mg / ml in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy in the cochlear implant surgery, paying special attention to the round window membrane completely submerged in the liquid, to the insertion of the electrode assembly
Sterile isotonic saline solution will be placed in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy during cochlear implant surgery, paying special attention to the fact that the round window membrane is completely submerged in the liquid, prior to insertion of the electrode array