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Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

NCT04793412 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-11

No results posted yet for this study

Summary

This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

Conditions

  • Asymmetric Hearing Loss
  • Single-sided Deafness
  • Unilateral Deafness

Interventions

DEVICE

Cochlear Implant

Cochlear implantation of a device from one of the three manufacturers available in the US.

Sponsors & Collaborators

  • St. Louis Children's Hospital

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Hearts for Hearing

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jill B Firszt, PhD · Washington University School of Medicine in St Louis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2026-10-30
Completion
2026-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04793412 on ClinicalTrials.gov