Status:
RECRUITING
Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
St. Louis Children's Hospital
University of Southern California
Conditions:
Asymmetric Hearing Loss
Single-sided Deafness
Eligibility:
All Genders
4-14 years
Phase:
NA
Brief 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 hear...
Detailed Description
The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sid...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures.
- Parents and child fluent in English. Parents desire bilateral hearing for their child, are willing to comply with study requirements, including the pre-implant HA phase, and are able to provide informed consent.
- Poor ear (AHL/SSD): PTA at .5, 1, 2 kHz \> 70 dB HL; Aided CNC word recognition score at 60 dB SPL \< 40%; SPHL duration ≥ 6 mos and ≤ 10 yrs at time of CI surgery; If \> 5 yrs of age, evidence of non-congenital SPHL onset (e.g., passed newborn hearing screening); If ≤ 5 yrs of age, no restrictions on SPHL onset.
- Better ear
- AHL: PTA at .5, 1, 2, 4 kHz \> 25 and ≤ 60 dB HL; Aided CNC word score at 60 dB SPL ≥ 55%; Currently using a HA; Stable hearing for the past 6-mo period. "Stable" is defined as thresholds that have not declined by more than 20 dB at three or more octave-interval audiometric frequencies.
- 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-mo period.
- Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL.
- To continue with cochlear implantation and into the CI phase of the study: Indication, via imaging, of a normal cochlear nerve and of cochlear anatomy in the ear to be implanted that allows full insertion of the electrode array. Imaging modality is at the discretion of the surgeon. In addition, better ear hearing must be stable throughout the HA phase.
- Exclusion Criteria for AHL/SSD Participants:
- Medical condition that contraindicates surgery; Actively using an implantable device in the ear to be implanted; Inability to complete study procedures; Unrealistic expectations related to the benefits and limitations of implantation; Unwillingness or inability to comply with all investigational requirements.
- 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; Abnormal cochlear nerve in the ear to be implanted; Hearing loss of neural or central origin.
Exclusion
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04793412
Start Date
September 20 2021
End Date
August 1 2026
Last Update
April 2 2025
Active Locations (5)
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1
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States, 90033
2
Fairview Health Services
Minneapolis, Minnesota, United States, 55454
3
Washington University School of Medicine/St Louis Children's Hospital
St Louis, Missouri, United States, 63110
4
Hearts for Hearing
Oklahoma City, Oklahoma, United States, 73120