Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
Completed · Not applicable
Conditions studied: Telemedicine
In brief
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.
Key facts
- Study ID
- NCT02644343
- Run by
- Cochlear
- People needed
- 40
- Starts
- 2016-01-01
- Expected to finish
- 2017-05-17
- Last updated by the study team
- 2020-11-24
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rocky Mountain Ear Center — Englewood, Colorado, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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