This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The Cochlear™ Nucleus ® System is a commercially available system intended for restoration of hearing sensation through electrical stimulation of the auditory nerve in adult patients with bilateral symmetrical sensorineural hearing loss.
Barrow Neurological Institute
Phoenix, Arizona, United States
Centre for Neurosciences
Tucson, Arizona, United States
Pacific Neuroscience Institute
Santa Monica, California, United States
University of Miami
Number of device and procedure-related adverse events and serious adverse events
Events will be summarized by type, frequency, and severity.
Time frame: 6-months post-activation
Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study.
Time frame: Pre-operative baseline, 6 months post-activation
Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition
The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study.
Time frame: Pre-operative baseline, 6 months post-activation
Number of device and procedure related adverse events and serious adverse events
Events will be summarized by type, frequency, and severity.
Time frame: 36-Months post-activation
Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline
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Coral Gables, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Midwest Ear Institute
Kansas City, Missouri, United States
New York University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Hospitals
Philadelphia, Pennsylvania, United States
The SSQ12 is a self-administered questionnaire designed to measure auditory disability across three categories: speech perception, spatial hearing, and qualities of hearing. Respondents rate their perceived ability or experience for each scenario questioned on a 'ruler' (horizontal line) that is numbered, left to right, from '0' corresponding to no ability, to '10,' corresponding to complete ability. Higher scores represent greater ability.
Time frame: Pre-operative baseline, 6 months post-activation
Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement
The THI is a 25-item self-assessment questionnaire used to assess the impact of tinnitus on a patient's quality of life. Items are grouped into functional, emotional, and catastrophic domains. A "yes" response is scored with 4 points; "sometimes" with 2 points; and "no" with zero points. Scores for the total scale range from 0 to 100 points, with higher scores representing greater perceived handicap.
Time frame: Pre-operative baseline, 6 months post-activation
Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted
The CNC word recognition test (for English speakers) and Spanish Bisyllabic word test (for Spanish speakers) will be administered in quiet at a level equal to 60dBA in the sound field. The tests will be scored as total number of words correct, which will be expressed as a percentage correct for this study.
Time frame: Pre-operative baseline, 3 months post-activation
Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition
The AzBio sentence test (for English speakers) and the Spanish AzBio sentence test (for Spanish speakers) will be utilised. These are validated tests to assess the open-set sentence recognition in quiet or in the presence of competing noise. For this study, the target sentences will be presented at a fixed level of 65dBA starting at a +10 dB signal-to-noise ratio using multi-talker babble as the competing signal. Each word in the sentence counts towards the overall score, which will be expressed as a percent correct for this study.
Time frame: Pre-operative baseline, 3 months post-activation
Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition
This will be evaluated for those participants who have a LFPTA (125-500 Hz) \<80 dB HL versus those participants who have a LFPTA (125-500 Hz) ≥ 80 dB HL.
Time frame: 6 months post-activation
Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition
This will be evaluated for those participants who have a LFPTA (125-500 Hz) \<80 dB HL versus those participants who have a LFPTA (125-500 Hz) ≥ 80 dB HL.
Time frame: 6 months post-activation