Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
NCT ID: NCT01072409
Last Updated: 2016-10-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2010-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Single arm design
Nucleus 5 Cochlear implant
Cochlear implant surgery
Cochlear implantation
Implantation
Interventions
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Nucleus 5 Cochlear implant
Cochlear implant surgery
Cochlear implantation
Implantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Teresa Zwolan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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CAM5255
Identifier Type: -
Identifier Source: org_study_id