The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The Hearing Cooperative Research Centre
Carlton, Victoria, Australia
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
Report on Degree of Hearing as Measured by Pure Tone Audiogram
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Time frame: 6 months and 12 months post activation
Report on Clinical Performance in Quiet and Noise
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Time frame: 3 months, 6 months and 12 months post activation
Report of Medical/Surgical and Device Related Adverse Events.
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
Time frame: 12 months post activation.
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.
Time frame: Preoperative and 6 months post activation
Glasgow Benefit Inventory (GBI).
Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.
Time frame: 6 months post activation
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