An observational study in Sensorineural Hearing Loss and Bilateral Hearing Loss, sponsored by Cochlear. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Cochlear · Observational
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
Individuals available from those sites invited to participate in the study consisting of up to 10 subjects implanted with the CI632D and up to 9 subjects with the CI632 in the CIDEX study (NCT04750642)
Exclusion Criteria:
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant
Device: CI632D
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant
Device: CI632
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits.
Time frame: 5 years post-activation
Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Speech perception in noise (AzBio sentence scores) for the best bilateral listening condition obtained between groups in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame: 5 years post-activation
Plan to share: No
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