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

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

Study Overview

• Status: Completed
• Conditions: Telemedicine
• Intervention / Treatment: Device: Custom Sound

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Ear Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27713
      • University of North Carolina
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Perception on Monosyllabic Word Test, CNC Words	Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.	2-4 weeks post remote programming session

Collaborators and Investigators

• Sponsor: Cochlear

Publications and helpful links

General Publications

• PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
• Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.
• Wesarg T, Wasowski A, Skarzynski H, Ramos A, Falcon Gonzalez JC, Kyriafinis G, Junge F, Novakovich A, Mauch H, Laszig R. Remote fitting in Nucleus cochlear implant recipients. Acta Otolaryngol. 2010 Dec;130(12):1379-88. doi: 10.3109/00016489.2010.492480. Epub 2010 Jun 30.
• McElveen JT Jr, Blackburn EL, Green JD Jr, McLear PW, Thimsen DJ, Wilson BS. Remote programming of cochlear implants: a telecommunications model. Otol Neurotol. 2010 Sep;31(7):1035-40. doi: 10.1097/MAO.0b013e3181d35d87.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): May 17, 2017
• Study Completion (ACTUAL): May 17, 2017

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (ESTIMATE): December 31, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CAM 5650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes