An interventional study of The Cochlear™ Nucleus® Cochlear Implant (CI) System in Hearing Loss, Unilateral and Deafness, Unilateral, sponsored by Cochlear. Active, not recruiting at 6 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Cochlear · Not applicable, Interventional, and Treatment
Among 30 studies in Hearing Loss, Unilateral with a site in United States — 5 open to participants now, 8 under way, none of them phase 3. Hearing Loss, Unilateral · United States.
Among the 30 studies in Hearing Loss, Unilateral with a site in United States, this one is the 5th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2022, is one of 18 with no phase, and was the 24th registered.
51 studies on the registry are indexed under Hearing Loss, Unilateral; 7 are open to participants now.
Browse Hearing Loss, Unilateral studies →5 of the 30 studies in Hearing Loss, Unilateral with a site in United States are open now. Recruiting first, the newest first:
Father Flanagan's Boys' Home · Sites in United States
Ages 6–16 · Healthy volunteers
University of California, San Francisco · Sites in United States
Ages 2–6
University of North Carolina, Chapel Hill · Sites in United States
Ages 7 mo–71 mo · Healthy volunteers
University of South Florida · Sites in United States
Ages 18–85
Med-El Corporation · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Hearing Loss, Unilateral studies recruiting now, 1 sets no upper age limit and 4 stop at 75 or younger; 5 take children under 18; 2 take healthy volunteers.
This study: 5 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 35 across 35 interventional studies indexed under Hearing Loss, Unilateral.
Median enrollment 35 across the 21 interventional studies, 75 across the 9 observational. Of the 18 that completed or were terminated, 14 (78%) have results posted.
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15 of 30 have an industry lead sponsor. The 10 most frequent:
Cochlear is the lead sponsor of 92 studies on the registry; 9 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Cochlear has 3 studies filed under Hearing Loss, Unilateral — fewer than ten, so there is no comparison to draw.
2 of the studies in Hearing Loss, Unilateral with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04506853Med-El CorporationSingle-Sided Deafness and Asymmetric Hearing Loss | 2026-12-21 |
| NCT05318417CochlearInvestigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness | 2027-05 |
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Among the 30 studies in Hearing Loss, Unilateral with a site in United States, from their registry updates:
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The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ear to be Implanted:
Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
Ear to be Implanted:
Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and
Normal Hearing Ear:
Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: The Cochlear™ Nucleus® Cochlear Implant (CI) System
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.
Time frame: pre-implantation, 12 months post-activation
Number of procedure and device related adverse events classified by type, frequency and severity.
Time frame: 36 months post-activation
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.
Time frame: pre-implantation, 12 months post-activation
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.
Time frame: pre-implantation, 12 months post-activation
Plan to share: No — Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for May 2027, 57 months after the start.
Of 24 interventional studies with no phase under Hearing Loss, Unilateral, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 83. This study's planned 57 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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