Frontlight ResearchEarly access
CompletedNo phase
Cochlear Implant With Dexamethasone Eluting Electrode Array
Key facts
- Who runs it
- Cochlear
- Where
- Englewood, Iowa City, and New York, United StatesSee the 4 sitesAlso in 2 other countries, 4 sites
- Trial code
- Status
- Completed
- People taking part
- 42 people enrolled
- Started
- 4 Oct 2021
- Ended
- 23 Feb 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CI632D
- CI632
- Record updated
- 22 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- History with cochlear implant surgery
- Allergy to dexamethasone
- Abnormal cochlear and middle ear anatomy
- Women who are pregnant or plan to become pregnant
- Unable/unwilling to comply to study requirements
Where in United States
Also in 2 other countries, 4 sites
- Rocky Mountain Ear CentreEnglewood, United States
- University of IowaIowa City, United States
- New York Eye & Ear infirmary of Mt. SinaiNew York, United States
- NYU Langone Medical CenterNew York, United States
About the trial
What the trial wants to find out
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
The 2 groups in the trial
- CI632D Investigational Medical Device (IMD)Treatment being tested
Treatment: CI632D
- CI632 Comparator DeviceExisting treatment, for comparison
Treatment: CI632
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
- Record updated
- 22 April 2025