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.
Study Type
OBSERVATIONAL
Enrollment
19
Rocky Mountain Ear Center
Englewood, Colorado, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGUniversity Hospitals Cleveland
Cleveland, Ohio, United States
RECRUITINGComparison 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
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