Cochlear Implant With Dexamethasone Eluting Electrode Array

Completed · Not applicable

Conditions studied: Sensorineural Hearing Loss, Bilateral Hearing Loss

In brief

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

Key facts

Study ID

NCT04750642

Run by

Cochlear

People needed

42

Starts

2021-10-04

Expected to finish

2024-02-23

Last updated by the study team

2025-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Rocky Mountain Ear Centre — Englewood, Colorado, United States
• University of Iowa — Iowa City, Iowa, United States
• New York Eye & Ear infirmary of Mt. Sinai — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Fiona Stanley Hospital — Murdoch, New South Wales, Australia
• Westmead Hospital — Sydney, New South Wales, Australia
• Royal Victorian Eye and Ear Hospital — East Melbourne, Victoria, Australia
• Gilles Hospital — Auckland, New Zealand

Full record on ClinicalTrials.gov

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