Back to resultsClinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nucleus 5 Cochlear implant
Cochlear implantation
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Speech perception ability in the CI alone condition
Eligibility Criteria
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.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
Single arm design
Outcomes
Primary Outcome Measures
CNC Monosyllabic Word Performance - Treated Ear
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01072409
Brief Title
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
Official Title
Clinical Evaluation of the Nucleus 5 Cochlear Implant System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Speech perception ability in the CI alone condition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
Single arm design
Intervention Type
Device
Intervention Name(s)
Nucleus 5 Cochlear implant
Intervention Description
Cochlear implant surgery
Intervention Type
Device
Intervention Name(s)
Cochlear implantation
Intervention Description
Implantation
Primary Outcome Measure Information:
Title
CNC Monosyllabic Word Performance - Treated Ear
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Zwolan, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
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