CI532 – Early Experience Study

Overview

To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Full Title of Study: “Implantation With the Cochlear Nucleus® CI532 Implant – Early Experience Study”

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: June 2017

Detailed Description

To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.

Interventions

  • Device: Cochlear Nucleus CI532
    • cochlear implantation

Arms, Groups and Cohorts

  • Experimental: Implanted
    • Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant

Clinical Trial Outcome Measures

Primary Measures

  • Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
    • Time Frame: 3 months postactivation of the sound processor
    • Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
  • Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
    • Time Frame: 3 months post-activation
    • unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise

Participating in This Clinical Trial

Inclusion Criteria

  • Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications – Post-linguistically deafened – Ability to complete age appropriate testing Exclusion Criteria:

  • Previous cochlear implantation in the ear to be implanted – Pre-linguistically deafened (onset of hearing loss at less than two years of age) – Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array – Diagnosis of retro-cochlear pathology – Diagnosis of auditory neuropathy – Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device – Unwillingness or inability to comply with all investigational requirements – Additional cognitive handicaps that would prevent participation on all study requirements

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cochlear
  • Provider of Information About this Clinical Study
    • Sponsor

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