This clinical study will test a new type of cochlear implant known as CI632D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation and reduce tissue injury, which is common after any type of surgery. The goal is to learn if the dexamethasone in the CI632D implant lessens these reactions inside the ear following surgery and if this makes the implant work as well, or even better, in improving hearing than what would be expected with a standard cochlear implant. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). The study participants will receive the CI632D experimental implant and will complete tests to see how well they are hearing and how well the implant is working.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
CI632D cochlear implant
CI632D, dexamethasone-eluting cochlear implant
UCLA Medical Center
Los Angeles, California, United States
Rocky Mountain Ear Center
Englewood, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
Henry Ford Health
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
New York Eye and Ear Infirmary
New York, New York, United States
NYU Langone Health
New York, New York, United States
Northwell Health Long Island Jewish Medical Center
New York, New York, United States
University Hospitals
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
...and 1 more locations
Coprimary endpoint 1: Mean monopolar 1 plus 2 (MP1+2) impedances (kOhms) at 3 months postactivation
Impedance will be measured across the active electrodes of the implant for each participant.
Time frame: On day of implantation and at 1- and 3-months postactivation
Coprimary endpoint 2: Mean change in word recognition score in the best unilateral listening mode in quiet from preimplantation to 3 months postactivation
Within-subject change in consonant-nucleus-consonant (CNC) words in quiet (% correct) calculated as the average across 2 runs of the test conducted on each participant. CNC word score ranges from 0-100%, higher the score the better the outcome.
Time frame: Preoperative baseline and 3-months postactivation
Mean within-subject change in the global score of the Speech, Spatial, and Qualities of hearing scale (SSQ12) from preimplantation to postimplantation
Within-subject change in Global SSQ12 scores at 6-months postactivation compared with preoperative baseline. The global SSQ12 score ranges from 0-10, higher the score the better the outcome.
Time frame: Preoperative baseline and 6-months postactivation
Mean within-subject change in sentence recognition score in the best unilateral listening mode in noise from preimplantation to postimplantation
Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome.
Time frame: Preoperative baseline and 6-months postactivation
Mean within-subject change in sentence recognition score in the best bilateral listening mode in noise from preimplantation to postimplantation
Within-subject change in AzBio sentence in noise score at a +10 dB Signal-to-Noise Ratio (SNR) at 6-months postactivation compared with preoperative baseline. AzBio score ranges from 0-100%, higher the score the better the outcome.
Time frame: Preoperative baseline and 6-months postactivation
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