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OpenTrials
Completed

NCT Number: NCT02644343

Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

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

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Key information

Conditions

Telemedicine

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Ear Center, Englewood, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom Sound

Device

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

Primary outcomes

  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 measured by percentage of words correct to examine their speech perception abilities after each remote programming session.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Acronym: TEL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2015
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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