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Dexamethasone-Eluting Cochlear Implant for Hearing Loss

N/A
Waitlist Available
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights

Study Summary

This trial looks at whether a cochlear implant that elutes dexamethasone can help reduce inflammation.

Who is the study for?
This trial is for adults who have developed moderate to profound sensorineural hearing loss after learning language. They must not be allergic to dexamethasone, pregnant, or planning pregnancy. Participants should be able and willing to follow study requirements and have normal cochlear and middle ear anatomy without previous cochlear implant surgeries.Check my eligibility
What is being tested?
The study is testing a new type of cochlear implant electrode array called CI632D that releases the drug dexamethasone to reduce inflammation in the ear. It's being compared with a standard electrode array, CI632, to see if it can improve hearing outcomes.See study design
What are the potential side effects?
Potential side effects may include local reactions at the surgery site due to dexamethasone release such as pain or infection, general discomfort from the implant procedure itself, and possible changes in taste sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe hearing loss in both ears, worse in high frequencies.
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I am 18 years old or older.
Select...
I have severe hearing loss in both ears, worse in high frequencies.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits.
Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.
Secondary outcome measures
Comparison of rate and type of device related adverse events between randomisation groups.
Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CI632D Investigational Medical Device (IMD)Experimental Treatment1 Intervention
Group II: CI632 Comparator DevicePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

CochlearLead Sponsor
88 Previous Clinical Trials
5,899 Total Patients Enrolled
NAMSAOTHER
43 Previous Clinical Trials
16,422 Total Patients Enrolled
AvaniaIndustry Sponsor
41 Previous Clinical Trials
8,454 Total Patients Enrolled

Media Library

Cochlear Implant Clinical Trial Eligibility Overview. Trial Name: NCT04750642 — N/A
Sensorineural Hearing Loss Research Study Groups: CI632D Investigational Medical Device (IMD), CI632 Comparator Device
Sensorineural Hearing Loss Clinical Trial 2023: Cochlear Implant Highlights & Side Effects. Trial Name: NCT04750642 — N/A
Cochlear Implant 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750642 — N/A
Sensorineural Hearing Loss Patient Testimony for trial: Trial Name: NCT04750642 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this experiment?

"If eligible, 120 individuals are required to sign up for this clinical trial. Those interested can join from New york Eye & Ear infirmary of Mt. Sinai in New York or University of California Los Angeles(UCLA), Medical center in Los Angeles."

Answered by AI

Are there a great many locations in Canada currently involved with this investigation?

"This trial is presently conducted in 16 sites, with presence spread across major cities like New york, Los Angeles and Ann Arbor. It may be useful to choose a nearby location to reduce travelling if you decide to partake in this study."

Answered by AI

Are there any remaining vacancies for participants in this experiment?

"Indeed, the clinicaltrial.gov website reveals that enrollment for this trial is currently ongoing. This research initiative was first unveiled on October 4th 2021 and has been up to date as of October 21st 2022. 120 participants are needed from 16 different medical facilities."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
New York Eye & Ear infirmary of Mt. Sinai
University of California Los Angeles(UCLA), Medical center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have hearing loss and feel left out of conversations most of the time. I would like to get some of my hearing improved. I am also on a fixed income and its very hard to afford hearing aids.
PatientReceived no prior treatments
~35 spots leftby Mar 2025