An interventional study of Investigational Software in Hearing Impairment, sponsored by Cochlear. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Cochlear · Not applicable, Interventional, and Treatment
Among 47 studies in Hearing Loss by Cochlear — 5 open to participants now, 12 under way, none of them phase 3. Hearing Loss · Cochlear.
Among the 47 studies in Hearing Loss by Cochlear, this one has the largest planned enrollment of the 40 interventional ones, is one of 5 that started in 2026, is one of 40 with no phase, reaches primary completion later than 11 of the 11 other live ones, and was the 47th registered.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 200 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →5 of the 47 studies in Hearing Loss by Cochlear are open now, in 6 countries. Each count lists the studies.
Of the 122 Hearing Loss studies recruiting now, 58 (48%) set no upper age limit and 42 (34%) stop at 75 or younger; 46 take children under 18; 46 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →47 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 5 started in 2026.
Median enrollment 31 across the 40 interventional studies, 153 across the 7 observational. Of the 34 that completed or were terminated, 24 (71%) have results posted.
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.
6 of the studies in Hearing Loss by Cochlear that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07139327CochlearA Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults | 2027-04 |
| NCT06098482CochlearAn Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App | 2027-05-02 |
| NCT06805175CochlearA Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration | 2027-06 |
| NCT06641999CochlearEvaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss | 2027-07 |
| NCT07287124CochlearA Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults | 2027-10 |
Among the 47 studies in Hearing Loss by Cochlear, from their registry updates:
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss. While these software tools are carefully tested before they are released, some challenges may only become apparent when they are used in everyday clinical practice. This research study will assess how well different fitting software technologies work in real-world clinical settings. Information will be collected to better understand how clinicians use the software, identify any usability issues, and find ways to improve the user experience and software design.
Inclusion Criteria: Recipient-Participant
Inclusion Criteria: Clinician-Participant
Exclusion Criteria: Recipient-Participant
Exclusion Criteria: Clinician-Participant
1) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
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.
Investigational Fitting Software and App to be used with a commercially approved sound processor
Device: Investigational Software
Next Generation Fitting software and Nucleus Smart App
To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions.
Proportion of task-completion ratings measured on a 5-point ordinal rating scale. The scale is as follows: 1 Unable to complete, 2 Completed after using help, 3 Completed after trying an incorrect option, 4 Completed after some exploration, 5 Completed at first attempt
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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