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Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants (TEL)

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.
ClinicalTrials.gov Identifier: NCT02644343
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.

Condition or disease Intervention/treatment Phase
Telemedicine Device: Custom Sound Not Applicable

Detailed Description:
Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
Study Start Date : January 2016
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : May 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remote Programming Group

Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.

The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.

Device: Custom Sound
Custom Sound is the programming software used to program Nucleus cochlear implants.




Primary Outcome Measures :
  1. Speech Perception on monosyllabic word test, CNC Words [ Time Frame: 2-4 weeks post remote programming session ]
    Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test (Peterson & Lehiste, 1962) to examine their speech perception abilities after each remote programming session.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist
  • Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor
  • A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1
  • Willingness to participate in and to comply with all requirements of the protocol
  • Able to demonstrate protocol competence as confirmed by primary audiologist

Exclusion Criteria:

  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery
  • Unwillingness or inability of the candidate to comply with all investigational requirements
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations
  • Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist

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): NCT02644343


Locations
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United States, Colorado
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27713
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Cochlear
  Study Documents (Full-Text)

Documents provided by Cochlear:
Study Protocol  [PDF] December 4, 2015
Statistical Analysis Plan  [PDF] August 3, 2015