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 range18 Years
SexALL
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required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use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
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)