Clinical trial NCT06936449: Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Official title: Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sensorineural Hearing Loss
Bilateral Hearing Loss
Keywords: cochlear implant
dexamethasone
bilateral hearing loss
sensorineural hearing loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 5 years post-activation
Secondary outcomes:
measure: Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation.
timeFrame: 5 years post-activation
measure: Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
timeFrame: 5 years post-activation
measure: 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.
timeFrame: 5 years post-activation
measure: 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.
timeFrame: 5 years post-activation
measure: 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.
timeFrame: 5 years post-activation
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Ear Center
state: Colorado
Study officials:
References: