CI532 - Early Experience Study

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss, Bilateral
• Interventions: Device: Cochlear Nucleus CI532

• Registration Number: NCT02755935
• Lead Sponsor: Cochlear

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.

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Study Start: 2016-05
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Status Verified: 2018-01
• Results First Submitted: 2018-01-23
• Results First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-02-20
• Results First Posted: 2018-02-22
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implanted	Cochlear Nucleus CI532	Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant

Primary Outcome Measures

Name	Time	Method
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear	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
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear	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.

Trial Locations

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

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Dallas Ear Institute; 🇺🇸 Dallas, Texas, United States