CHANGE Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Nucleus CI532 cochlear implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet current cochlear implant indications at the implanting centre In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted. Fluent speaker in the local language used to assess clinical performance Eighteen years of age or older at the time of implantation with no upper age limit Exclusion Criteria: Evidence of hearing loss prior to 5 years of age. Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted. Additional disabilities that may affect the subject's participation or safety during the clinical investigation. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway. Active middle-ear infection, Tympanic membrane perforation Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices Unwillingness or inability of the candidate to comply with all investigational requirements. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak. Patients with recurrent episodes of bacterial meningitis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantation with Nucleus CI532 cochlear implant<br>All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. | Device: Nucleus CI532 cochlear implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 12 months post activation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months post activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear Prosthesis Implantation