CI532 - Early Experience Study

Sensorineural Hearing Loss, Bilateral Clinical Trial

Official title:

Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755935
• Other study ID #: CAM5660
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: February 20, 2018
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss, Bilateral

Intervention

Device:
• Cochlear Nucleus CI532
cochlear implantation

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan
United States	Center for Hearing and Balance	Chesterfield	Missouri
United States	Dallas Ear Institute	Dallas	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	NorthShore University	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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