Impact of Anatomy-Based Cochlear Implant Programming on Early Performance (NCT06734039) | Clinical Trial Compass
By InvitationNot Applicable
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
United States50 participantsStarted 2025-11-10
Plain-language summary
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.
Who can participate
Age range
18 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.
* At least 18 years of age
* Is a cochlear implant candidate as deemed by the participating center
* Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear.
* For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
* Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear.
* Programmed with electric-only stimulation in the implanted ear
* The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
* Post-operative CT scan allows for completion of OTOPLAN analysis
* ABF settings possible at defaults in clinical programming software
* Minimum of 10 active electrodes at activation
* Programmed using a Fine Structure coding strategy
* English is the primary language
* Willing and able to comply with all scheduled procedures as defined in the protocol
Exclusion Criteria:
* Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
* Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
* Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
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
1
Percent correct on AzBio Sentences in Noise
Timeframe: 3 to 7 months
2
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)