The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.
Stanford University
Palo Alto, California, United States
RECRUITINGRocky Mountain Ear Center
Englewood, Colorado, United States
RECRUITINGUniversity of Iowa
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.
Time frame: pre-implantation, 12 months post-activation
Number of procedure and device related adverse events classified by type, frequency and severity.
Time frame: 36 months post-activation
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.
Time frame: pre-implantation, 12 months post-activation
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.
Time frame: pre-implantation, 12 months post-activation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Iowa City, Iowa, United States
New York Eye and Ear Infirmary
New York, New York, United States
RECRUITINGUniversity of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
WITHDRAWNUniversity of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
Dallas, Texas, United States
WITHDRAWNVirginia Mason Medical Center
Seattle, Washington, United States
RECRUITING