Can a cochlear implant beat a hearing aid for kids with one-sided deafness?
NCT ID NCT04793412
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares cochlear implants to hearing aids in 80 children aged 4 to 14 with hearing loss in one ear. Researchers measure how well kids understand speech and hear in noise before and after getting an implant. The goal is to see if the implant provides better hearing than a hearing aid.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 14 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Philadelphia - Buerger Center
Philadelphia, Pennsylvania, 19104, United States
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Fairview Health Services
Minneapolis, Minnesota, 55454, United States
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Hearts for Hearing
Oklahoma City, Oklahoma, 73120, United States
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Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033, United States
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Washington University School of Medicine/St Louis Children's Hospital
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a custom sound map unlock better hearing for cochlear implant users?
- Custom cochlear implant tuning based on ear anatomy may sharpen hearing in noise and music for the single-sided deaf
- Could a cochlear implant help babies hear in one ear?
- Cochlear implants for Single-Sided deafness: a Cost-Effective solution?
- Can tweaking cochlear implant settings help people hear better in noise?
- Could a cochlear implant help kids who are deaf in one ear?