Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

Not Applicable

Completed

• Conditions: Telemedicine

• Registration Number: NCT02644343
• Lead Sponsor: Cochlear

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Study Start: 2016-01
• Primary Completion: 2017-05-17
• Study Completion: 2017-05-17
• Results First Submitted: 2020-10-18
• Results First Submitted QC: 2020-10-18
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Results First Posted: 2020-11-10
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Speech Perception on Monosyllabic Word Test, CNC Words	2-4 weeks post remote programming session	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.

Trial Locations

Locations (4)

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States