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Procedure

Cochlear Implant for Unilateral Hearing Loss

N/A
Recruiting
Led By Jill B Firszt, PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Better ear SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-month period
At least 4 years of age and up to 14 years, 11 months of age and able to complete all investigational procedures
Must not have
Exclusions for cochlear implantation and the CI phase of the study: Cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
Hearing loss of neural or central origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a cochlear implant (CI) performs better than a hearing aid (HA) for children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). The study also looks at whether using a CI in combination with a hearing aid (bimodal hearing) is more effective than using a hearing aid alone.

Who is the study for?
This trial is for children aged 4 to nearly 15 with asymmetric hearing loss (AHL) or single-sided deafness (SSD). They must have a certain level of hearing loss in one ear and be currently using a hearing aid. The better ear must meet specific hearing criteria, depending on whether it's AHL or SSD. Participants need stable hearing, fluency in English, and parents willing to comply with study requirements.
What is being tested?
The study tests how well children with AHL or SSD hear before and after getting a cochlear implant compared to their current performance with a hearing aid. It also looks at the benefits of having both a cochlear implant in one ear and either normal hearing or using a hearing aid in the other.
What are the potential side effects?
While not explicitly listed here, common side effects from cochlear implants can include discomfort around the implant site, ringing in the ears (tinnitus), dizziness, changes in taste sensation, and device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hearing in my better ear is good and stable for the last 6 months.
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I am between 4 and 14 years old and can follow the study's procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My ear structure allows for full cochlear implant electrode insertion.
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I have hearing loss that is not due to ear damage.
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I have a health issue that makes surgery unsafe for me.
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I cannot complete all required study procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits 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 Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant
Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
+1 more
Secondary study objectives
Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant
Change in Bimodal sound localization from Pre-Implant to 15 months post-implant
Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant
+5 more

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: AHL/SSDExperimental Treatment1 Intervention
Children with asymmetric hearing loss or single-sided deafness
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cochlear Implant
2019
N/A
~310

Find a Location

Who is running the clinical trial?

Hearts for HearingUNKNOWN
5 Previous Clinical Trials
116 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,752 Total Patients Enrolled
University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,878 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,343,828 Total Patients Enrolled
St. Louis Children's HospitalOTHER
29 Previous Clinical Trials
87,742 Total Patients Enrolled
University of Southern CaliforniaOTHER
946 Previous Clinical Trials
1,604,539 Total Patients Enrolled
Jill B Firszt, PhDPrincipal InvestigatorWashington University School of Medicine in St Louis
3 Previous Clinical Trials
149 Total Patients Enrolled

Media Library

Cochlear Implant (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04793412 — N/A
Unilateral Hearing Loss Research Study Groups: AHL/SSD
Unilateral Hearing Loss Clinical Trial 2023: Cochlear Implant Highlights & Side Effects. Trial Name: NCT04793412 — N/A
Cochlear Implant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04793412 — N/A
~18 spots leftby Dec 2025
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