Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Study Overview
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Brief Summary
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The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design. Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

Official Title
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Clinical Investigation of the Nucleus® CI532 Cochlear Implant

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: Eighteen years of age or older at the time of implantation Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow) Native speaker in the local language used to assess clinical performance Exclusion Criteria: Evidence of hearing loss prior to 5 years of age Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear 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 such as undergoing a post-operative digital volume tomography/ConeBeam scan Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak Patients with recurrent episodes of bacterial meningitis Pregnancy or breast-feeding Known allergies to components of the implant Wearing other active implants with known interference with cochlear implants

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: Nucleus CI532 cochlear implant<br> | 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 |
| --- | --- | --- |
| Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan | The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging. | up to one month post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Array Proximity to the Modiolus Measured Using the Wrapping Factor | The ratio of the active array length and the corresponding lateral wall length | up to one month post-surgery | 
| Surgeon Questionnaire on Implant Surgery | To collect experiences using the CI532. At each surgery, the surgeon was asked whether overall the CI532 was easy to handle and the EA32 easy to insert. We counted the number of surgeons who strongly agreed or who agreed. | at time of surgery | 
| Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months | Change in percent correct speech recognition test scores for implant ear alone and best aided | baseline and 6 months post activation | 
| Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire | The Glasgow Benefit Inventory is a single time point measure of patient reported benefit. A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100. | 6 months post activation | 
| Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months | Rating scale. 0=worst; 10=best | baseline and 6 months post activation | 
| Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months | We report only the change for the 500 Hz frequency. | baseline and 6 months post activation | 
| Number of Adverse Events at Surgery |  | at time of surgery | 
| Number of Adverse Events Post Surgery to 6 Months Post-activation |  | post surgery to 6 months post-activation |