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Status:

COMPLETED

CI532 - Early Experience Study

Lead Sponsor:

Cochlear

Conditions:

Sensorineural Hearing Loss, Bilateral

Eligibility:

All Genders

12+ years

Phase:

NA

Brief Summary

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

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2017

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT02755935

Start Date

May 1 2016

End Date

September 1 2017

Last Update

March 20 2018

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

NorthShore University

Skokie, Illinois, United States, 60201

2

University of Iowa

Iowa City, Iowa, United States, 52242

3

The University of Michigan

Ann Arbor, Michigan, United States, 48108

4

Center for Hearing and Balance

Chesterfield, Missouri, United States, 63017