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Procedure

Cochlear Implant Fitting Methods for Hearing Loss (CALOS4 Trial)

N/A
Recruiting
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
Be older than 18 years old
Must not have
Diagnosis of auditory neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days (in booth testing)
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to gather information from patients who have recently received a cochlear implant to improve the way the implant is programmed for better results."

Who is the study for?
This trial is for adults over 18 who became deaf after age 2 and now have a CI600 or CI500 series cochlear implant. Participants must understand the language used in speech tests and agree to follow the study rules.
What is being tested?
The study compares two ways of setting up cochlear implants: one uses behavioral fitting with Custom Sound Suite software, and the other uses loudness scaling with Nexus System. It's to find out which method works best post-activation.
What are the potential side effects?
Since this trial involves programming methods for cochlear implants rather than drugs, traditional side effects are not applicable. However, participants may experience differences in hearing quality or comfort levels with each fitting approach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I became severely hearing impaired after age 2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with auditory neuropathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Adaptive sentence in noise scores (S0N0 test setup)
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL
Secondary study objectives
Adaptive Digit Triplet Test (DTT) in noise scores
Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL
Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.Experimental Treatment2 Interventions
Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS

Find a Location

Who is running the clinical trial?

CochlearLead Sponsor
93 Previous Clinical Trials
6,105 Total Patients Enrolled
84 Trials studying Hearing Loss
5,835 Patients Enrolled for Hearing Loss
QbD ClinicalUNKNOWN
4 Previous Clinical Trials
348 Total Patients Enrolled
2 Trials studying Hearing Loss
196 Patients Enrolled for Hearing Loss
AvaniaIndustry Sponsor
52 Previous Clinical Trials
10,025 Total Patients Enrolled
9 Trials studying Hearing Loss
536 Patients Enrolled for Hearing Loss
Anke PlasmansStudy DirectorCochlear
~4 spots leftby Mar 2025
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