Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants (TEL)

Cochlear

Status: Completed

Conditions: Telemedicine

Treatments: Device: Custom Sound

Study type: Interventional

Funder types: Industry

Identifiers

NCT02644343

CAM 5650

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Remote Programming Group

Experimental group

Description:

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.

Treatment:

Device: Custom Sound