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Clinical Evaluation of the Nucleus 5 CI System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kathryn Henion, Cochlear
ClinicalTrials.gov Identifier:
NCT01072409
First received: February 18, 2010
Last updated: July 31, 2012
Last verified: July 2012
History of Changes

February 18, 2010
July 31, 2012
March 2010
September 2012   (final data collection date for primary outcome measure)
Speech perception performance in quiet and noise [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01072409 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of the Nucleus 5 CI System
Clinical Evaluation of the Nucleus 5 Cochlear Implant System

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

Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hearing Loss
  • Device: Nucleus 5 Cochlear implant
    Cochlear implant surgery
  • Device: Cochlear implantation
    Implantation
Single Arm
Single arm design
Interventions:
  • Device: Nucleus 5 Cochlear implant
  • Device: Cochlear implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01072409
CAM5255
No
Kathryn Henion, Cochlear
Kathryn Henion
Not Provided
Principal Investigator: Teresa Zwolan, PhD University of Michigan
Cochlear
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP