Cochlear implantation for children with uneven hearing loss or deafness in one ear
Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
This study tests whether cochlear implants can help children with uneven hearing loss or deafness in one ear hear better compared to using hearing aids alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 4 Years to 14 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT04793412 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cochlear implants in children with asymmetric hearing loss or single-sided deafness by comparing their performance with hearing aids before implantation and with cochlear implants afterward. The study is conducted in two phases: a pre-implant phase using hearing aids for at least four months, followed by a 15-month post-implant phase. It also assesses the benefits of using both a cochlear implant and a hearing aid simultaneously. The trial collects longitudinal data to understand the outcomes better and factors influencing cochlear implant success.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 14 years with asymmetric hearing loss or single-sided deafness who meet specific audiometric criteria.
Not a fit: Patients with stable hearing loss that does not meet the study's criteria or those who are not fluent in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve hearing capabilities and quality of life for children with asymmetric hearing loss or single-sided deafness.
How similar studies have performed: Other studies have shown promising results with cochlear implants in similar populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 4 other locations
- Keck School of Medicine of the University of Southern California — Los Angeles, California, United States (Recruiting)
- Fairview Health Services — Minneapolis, Minnesota, United States (Recruiting)
- Washington University School of Medicine/St Louis Children's Hospital — Saint Louis, Missouri, United States (Recruiting)
- Hearts for Hearing — Oklahoma City, Oklahoma, United States (Recruiting)
- Children's Hospital of Philadelphia - Buerger Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jill B Firszt, PhD — Washington University School of Medicine in St Louis
- Study coordinator: Noel Dwyer, AuD
- Email: NDwyer@wustl.edu
- Phone: 314-362-7245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.