Implantation With the Nucleus CI532 Cochlear Implant in Adults

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 23, 2017

Interventions

  • Device: CI532 cochlear implant

Arms, Groups and Cohorts

  • Experimental: Surgical
    • Subjects to be implanted with the CI532 cochlear implant in one ear

Clinical Trial Outcome Measures

Primary Measures

  • AzBio Sentence Recognition in Noise
    • Time Frame: 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 Measures

  • Glasgow Benefit Inventory
    • Time Frame: 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.
  • Speech, Spatial, and Qualities of Hearing Scale
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cochlear
  • Collaborator
    • NYU Langone Health
  • Provider of Information About this Clinical Study
    • Sponsor

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