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 range5 Years
SexALL
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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).
✓. Patent cochlea and normal cochlear anatomy.
Exclusion criteria
✕.3 Criteria for Exclusion in Populations 1 and 2
✕. 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.
✕
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