Implantation With the Nucleus CI532 Cochlear Implant in Adults

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Surgical	CI532 cochlear implant	Subjects to be implanted with the CI532 cochlear implant in one ear

Primary Outcome Measures

Name	Time	Method
AzBio Sentence Recognition in Noise	3 months post-activation	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.

Secondary Outcome Measures

Name	Time	Method
Speech, Spatial, and Qualities of Hearing Scale	6 months post-activation	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).
Glasgow Benefit Inventory	6 months post-activation	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.