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Keep this study
Lead
Cochlear
With
NAMSA
Avania
Vanderbilt University
The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
18 years or older at time of consent.
You may not be if
Abnormal cochlear and middle ear anatomy
History with cochlear implant surgery
Allergy to dexamethasone
Women who are pregnant or plan to become pregnant
Unable/unwilling to comply to study requirements
Clareo Health | Cochlear Implant With Dexamethasone Eluting Electrode Array
