Completed

TELSafety and Efficacy of Remote Programming of Nucleus Cochlear Implants

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What is being tested

Custom Sound

Device
Who is being recruted

Over 12 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2016
See protocol details

Summary

Principal SponsorCochlear
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleSafety and Efficacy of Remote Programming of Nucleus Cochlear Implants
NCT02644343
Principal SponsorCochlear
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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
Show More Criteria
4 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Rocky Mountain Ear Center

Englewood, United StatesOpen Rocky Mountain Ear Center in Google Maps
Suspended

University of Michigan

Ann Arbor, United States
Suspended

University of North Carolina

Chapel Hill, United States
Suspended

The Medical College of Wisconsin

Milwaukee, United States
Completed4 Study Centers