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

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ClinicalTrials.gov Identifier: NCT01072409
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : September 25, 2014
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):

Brief Summary:
To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Condition or disease Intervention/treatment
Hearing Loss Device: Nucleus 5 Cochlear implant Device: Cochlear implantation

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Nucleus 5 Cochlear Implant System
Study Start Date : March 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Single Arm
Single arm design
Device: Nucleus 5 Cochlear implant
Cochlear implant surgery
Device: Cochlear implantation

Primary Outcome Measures :
  1. CNC Monosyllabic Word Performance - Treated Ear [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072409

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Principal Investigator: Teresa Zwolan, PhD University of Michigan

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT01072409     History of Changes
Other Study ID Numbers: CAM5255
First Posted: February 22, 2010    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: October 27, 2016
Last Verified: September 2014

Keywords provided by Cochlear:
Speech perception ability in the CI alone condition

Additional relevant MeSH terms:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms