CompletedNot Applicable

Cochlear Implant With Dexamethasone Eluting Electrode Array

United States, Australia42 participantsStarted 2021-10-04

Plain-language summary

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative

Timeframe: Six months postoperative

Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D

Timeframe: Six months postoperative

Trial details

NCT IDNCT04750642

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-07

Results submitted2025-03-13

View on ClinicalTrials.gov More Sensorineural Hearing Loss trials