Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents (NCT01975571) | Clinical Trial Compass
CompletedNot Applicable
Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
United States20 participantsStarted 2011-07
Plain-language summary
The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.
Who can participate
Age range
5 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.
Inclusion criteria
.1 Criteria for Inclusion in Population 1
. Eighteen year of age or older at the time of implantation.
. Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
. Speech Perception:
. English spoken as a primary language.
. Willingness to comply with all study requirements.
. Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day).
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
Change in CNC Word Perception
Timeframe: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children
. Medical or psychological conditions that contraindicate undergoing surgery.
. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
. Unwillingness or inability of the candidate to comply with all investigational requirements.