Asymmetric Hearing LossNCT04793412
Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
A study testing Cochlear Implant in people with Asymmetric Hearing Loss and Single-sided Deafness, run by Washington University School of Medicine at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymmetric Hearing Loss, Single-sided Deafness, Unilateral Deafness
- What is being tested?
- Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Sep 2021to 30 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
Fairview Health Services
Minneapolis, Minnesota, 55454
Hearts for Hearing
Oklahoma City, Oklahoma, 73120
Children's Hospital of Philadelphia - Buerger Center
Philadelphia, Pennsylvania, 19104
Washington University School of Medicine/St Louis Children's Hospital
St Louis, Missouri, 63110
About this study
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.
Read the 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-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI. The AHL/SSD groups are tested for change in performance pre- to post-implant. Investigators also collect longitudinal data over 12 months (matching the 3 to 15 month post-implant timeframe) from normal hearing (NH) participants to provide additional information about outcome trajectory due to development alone. The NH participants are matched to AHL/SSD participants on age, gender and parent education. Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study 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.
- Being tested
- Cochlear Implant
- Keywords
- hearing loss, cochlear implant
- Medical subject headings
- Hearing Loss, Unilateral, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantDevice
Cochlear implantation of a device from one of the three manufacturers available in the US.
| Study group | Role | What they receive |
|---|---|---|
| AHL/SSD | Experimental | Children with asymmetric hearing loss or single-sided deafness Receives: Device: Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA.
Measured: Pre-Implant and 12 months post-implant
Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant
Speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.
Measured: Pre-implant and 15 months post-implant
Post-implant bimodal vs better ear alone speech understanding in noise
Post-implant speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) compared to the better ear alone condition.
Measured: 15 months post-implant
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
The trajectory of speech reception thresholds (SRT) for understanding noise throughout the CI Phase (5 visits post-implant) in the bimodal condition is compared to the trajectory throughout the HA Phase (5 visits pre-implant) in the best aided condition.
Measured: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
Secondary outcomes (8)
Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant
FM tone sound field threshold levels in the poor ear alone with a CI compared to pre-implant threshold levels with a HA
Measured: Pre-implant and 12 months post-implant
Change in Bimodal sound localization from Pre-Implant to 15 months post-implant
RMS error scores for a sound localization task in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.
Measured: Pre-implant and 15 months post-implant
Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant
CNC monosyllabic word recognition at a soft level in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.
Measured: Pre-implant and 12 months post-implant
Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Measured: Pre-implant and 15 months post-implant
Change in SSQ ratings from Pre-Implant to 15 months post-implant
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Measured: Pre-implant and 15 months post-implant
Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant
Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.
Measured: Pre-implant and 15 months post-implant
Post-implant bimodal vs better ear alone sound localization
Post-implant RMS error scores for the sound localization task are compared in the bimodal condition to the better ear alone condition.
Measured: 15 months post-implant
Post-implant bimodal vs better ear alone soft speech understanding
Post-implant word recognition scores at soft levels are compared in the bimodal condition to the better ear alone condition.
Measured: 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start20 Sep 2021
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymmetric Hearing LossStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis Children's Hospital, University of Southern California, Children's Hospital of Philadelphia, Hearts for Hearing, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Jill B Firszt, PhD, Principal investigator, Washington University School of Medicine in St Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793412
- Sponsor's protocol ID
- 202007142
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be shared through presentations at relevant scientific meetings and through publication(s) in peer-reviewed journals. As required by the NIH Public Access Policy, an electronic version of final manuscripts resulting from this study will be submitted to the NIH National Library of Medicine PubMed Central (PMC) upon acceptance for publication. The few numbers of children at each study site who meet the inclusion criteria and receive a cochlear implant puts participant's privacy at risk if individual data are shared.