CI532 - Early Experience Study

Cochlear24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sensorineural Hearing Loss, Bilateral

Interventions

Cochlear Nucleus CI532DEVICE

cochlear implantation

Eligibility

Sex: ALLMin age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

NorthShore University

Skokie, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

The University of Michigan

Ann Arbor, Michigan, United States

Center for Hearing and Balance

Chesterfield, Missouri, United States

Outcomes

Primary Outcomes

Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear

Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.

Time frame: 3 months postactivation of the sound processor

Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear

unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise

Time frame: 3 months post-activation

Data from ClinicalTrials.gov

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