Implantation With the Nucleus CI532 Cochlear Implant in Adults

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. The 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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Implantation With the Nucleus CI532 Cochlear Implant in Adults

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: CI532 cochlear implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet current cochlear implant criteria at the implanting center 18 years or older with bilateral sensorineural hearing loss Limited benefit from appropriate binaural hearing aids Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted Fluent speaker in the language used to assess clinical performance Exclusion Criteria: Evidence of hearing loss prior to age 5 Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz Simultaneous bilateral implantation prior to the study Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery Cochlear anomaly that might prevent complete insertion of the electrode array 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 Unwillingness or inability co comply with all investigational requirements Patients with existing cerebral shunts or drains 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: Surgical<br>Subjects to be implanted with the CI532 cochlear implant in one ear | Device: CI532 cochlear implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AzBio Sentence Recognition in Noise | The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. | 3 months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Benefit Inventory | The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100. | 6 months post-activation | 
| Speech, Spatial, and Qualities of Hearing Scale | The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10). | 6 months post-activation |