CI532 - Early Experience Study

NCT02755935 | Completed Results

• 1 other identifier: CAM5660
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Sensorineural Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  3 months post-activation

Study Arms (1)

Implanted

EXPERIMENTAL

Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant

Device: Cochlear Nucleus CI532

Interventions

Cochlear Nucleus CI532 DEVICE

cochlear implantation

Implanted

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (6)

NorthShore University

Skokie, Illinois, 60201, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

The University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Center for Hearing and Balance

Chesterfield, Missouri, 63017, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Dallas Ear Institute

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ginger Grant, AuD
• Organization: Cochlear Americas

ggrant@cochlear.com

410-375-0883

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 20, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-01

Locations

US (6)