Bilateral Hearing Loss, Sensorineural Hearing Loss
Conditions
Keywords
cochlear implant, dexamethasone, bilateral hearing loss, sensorineural hearing loss
Brief summary
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.
Interventions
Sponsors
Cochlear
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation. * Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642). * Willing and able to provide written informed consent.
Exclusion criteria
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator. * Additional disabilities that may affect the subject's participation or safety during the clinical investigation. * Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 5 years post-activation |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation. | 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. | 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. | 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. | 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. | 5 years post-activation |
Countries
United States
Contacts
CONTACTPRS Specialist
Outcome results
None listed