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N/A Completed N=40 Treatment

Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

Telemedicine
Source: ClinicalTrials.gov NCT02644343 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Speech Perception on Monosyllabic Word Test, CNC Words — 70.5; 72.4; 72.5 percentage of words correct

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Speech Perception on Monosyllabic Word Test, CNC Words		 70.5; 72.4; 72.5 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02644343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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