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Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

NCT ID: NCT02644343

Last Updated: 2020-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-17

Brief Summary

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

Detailed Description

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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.

Conditions

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Telemedicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Custom Sound

Intervention Type DEVICE

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

Interventions

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Custom Sound

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rocky Mountain Ear Center

Englewood, Colorado, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15035561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14485785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20586675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20147864 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CAM 5650

Identifier Type: -

Identifier Source: org_study_id