Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Nucleus 5 Cochlear implant; Device: Cochlear implantation

• Registration Number: NCT01072409
• Lead Sponsor: Cochlear

Brief Summary

To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Detailed Description

Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.

Study Timeline

• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Study Start: 2010-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-09
• Results First Submitted: 2014-09-18
• Results First Submitted QC: 2014-09-18
• Results First Posted: 2014-09-25
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Eighteen years of age or older at the time of the study.
• Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
• Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)
• English spoken as the primary language.
• Willingness to participate in and to comply with all requirements of the study
• Subject may receive bilateral simultaneous cochlear implants.

Exclusion Criteria

• Previous cochlear implant experience
• Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
• Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• Normal hearing in one or both ears.
• Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
• Active middle-ear infection.
• Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Nucleus 5 Cochlear implant	Single arm design
Single Arm	Cochlear implantation	Single arm design

Primary Outcome Measures

Name	Time	Method
CNC Monosyllabic Word Performance - Treated Ear	12 months	CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States