Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
1 other identifier
interventional
49
1 country
1
Brief Summary
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2014
CompletedOctober 27, 2016
September 1, 2014
2.7 years
February 18, 2010
September 18, 2014
September 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (1)
Single Arm
OTHERSingle arm design
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Teresa Zwolan, Ph.D.
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa Zwolan, PhD
University of Michigan
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
February 18, 2010
First Posted
February 22, 2010
Study Start
March 1, 2010
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
October 27, 2016
Results First Posted
September 25, 2014
Record last verified: 2014-09