Active — Not RecruitingNot Applicable

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

United States80 participantsStarted 2021-09-20

Plain-language 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.

Who can participate

Age range

4 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ph…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant

Timeframe: Pre-Implant and 12 months post-implant

Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant

Timeframe: Pre-implant and 15 months post-implant

Post-implant bimodal vs better ear alone speech understanding in noise

Timeframe: 15 months post-implant

Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time

Timeframe: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits

Trial details

NCT IDNCT04793412

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

View on ClinicalTrials.gov More Asymmetric Hearing Loss trials