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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
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

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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
4 Previous Clinical Trials
91 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,580,979 Total Patients Enrolled
University of MinnesotaOTHER
1,380 Previous Clinical Trials
1,588,665 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

Frequently Asked Questions

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

Is it feasible for me to participate in this experiment?

"In order to take part in this experiment, subjects must possess unilateral hearing loss and be between 4-14 years old. Approximately 80 participants are being sought after for the trial."

Answered by AI

Does this medical research encompass individuals who are over 35 years old?

"This research study is looking for participants aged between 4 and 14 years old."

Answered by AI

How widespread is the implementation of this clinical trial?

"This medical trial is running from Washington University School of Medicine/St Louis Children's Hospital in Saint Louis, Missouri, Fairview Health Services in Minneapolis, Minnesota and the Children’s Hospital of Philadelphia - Buerger Center in Philadelphia, Pennsylvania. Additionally, 5 extra sites are also taking part."

Answered by AI

Is this trial actively seeking participants?

"The posting on clinicaltrials.gov reveals that recruitment is happening for this medical trial, which was originally posted on September 20th 2021 and recently updated on May 31st 2022."

Answered by AI

How many participants are involved in this clinical research?

"Affirmative, the clinicaltrials.gov registry signals that this medical trial is searching for applicants; it was initially published on September 20th 2021 and last updated on May 31st 2022. Five different healthcare facilities need to recruit 80 total participants."

Answered by AI

What is the aim of this research endeavor?

"The primary aim of this study, evaluated during a pre-implant period and 15 months following implantation, is to assess how bimodal use of the device affects speech recognition in noisy environments relative to single ear usage. Secondary objectives include measuring post-implant sound localization accuracy through RMS error scores for the localization task; evaluating changes in SSQ ratings from pre-implantation to 15 months afterwards with questionnaires completed by participants or their parents (if applicable); and determining differences in audibility via FM tone sound field threshold levels between poor ear alone CI users compared to its baseline HA level prior to implantation."

Answered by AI

Who else is applying?

What site did they apply to?
Fairview Health Services
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
2021. "Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04793412.
All > Hearing Loss > Cochlear Implant
~30 spots leftby Dec 2025
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