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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Speech perception performance in quiet and noise [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072409

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

No publications provided

Responsible Party: Kathryn Henion, Principal Clinical Studies Specialist, Cochlear
ClinicalTrials.gov Identifier: NCT01072409     History of Changes
Other Study ID Numbers: CAM5255
Study First Received: February 18, 2010
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014