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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072409
First Posted: February 22, 2010
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cochlear
  Purpose
To evaluate the performance of the Nucleus 5 Cochlear Implant System.

Condition Intervention
Hearing Loss Device: Nucleus 5 Cochlear implant Device: Cochlear implantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Nucleus 5 Cochlear Implant System

Resource links provided by NLM:


Further study details as provided by Cochlear:

Primary Outcome Measures:
  • 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.


Enrollment: 49
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
Single arm design
Device: Nucleus 5 Cochlear implant
Cochlear implant surgery
Device: Cochlear implantation
Implantation

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

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
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.
  Contacts and Locations
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


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Cochlear
Investigators
Principal Investigator: Teresa Zwolan, PhD University of Michigan
  More Information

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT01072409     History of Changes
Other Study ID Numbers: CAM5255
First Submitted: February 18, 2010
First Posted: February 22, 2010
Results First Submitted: September 18, 2014
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