Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

Conditions
-----------------
Telemedicine

Intervention / Treatment
-----------------
* Device: Custom Sound


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Programming Group<br>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<br>* Custom Sound is the programming software used to program Nucleus cochlear implants.<br>|

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 |