The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Cochlear implant and audio processor
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
WITHDRAWNUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGNew York Eye and Ear Infirmary
New York, New York, United States
Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
Time frame: Three years (36 months) post implantation
Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation
Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better)
Time frame: Three years (36 months) post implantation
Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation
Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)
Time frame: Three years (36 months) post implantation
Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of North Carolina
Chapel Hill, North Carolina, United States
ACTIVE_NOT_RECRUITINGVirginia Mason Medical Center
Seattle, Washington, United States
RECRUITINGSunnybrook Health Sciences Center
Toronto, Ontario, Canada
RECRUITINGSubjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better)
Time frame: Three years (36 months) post implantation
Long term safety will be evaluated for all study subjects through three (36 months) years post implantation
Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.
Time frame: Three years (36 months) post implantation