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Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

NCT05552118 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2026-01-16

No results posted yet for this study

Summary

The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

Conditions

Interventions

PROCEDURE

Cochlear™ Remote care

Cochlear™ Remote Check is a virtual assessment tool which helps the clinician to monitor the participant hearing progress remotely. It allows the participant to complete a series of hearing tests using the Cochlear™ Nucleus® Smart App then electronically send the results to the clinician for review. Cochlear™ Remote Assist enables a video call appointment through the Cochlear™ Custom Sound® Pro software and the Nucleus® Smart App. When remote check requires further follow-up, it allows the clinician to make programming adjustments and sound processor settings without a clinic visit.

PROCEDURE

Standard of care

Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro

DEVICE

Compatible Implant Series and Compatible Sound Processors

Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate.

Sponsors & Collaborators

  • QbD Clinical

    collaborator INDUSTRY

  • Avania

    collaborator INDUSTRY

  • TFS

    collaborator UNKNOWN

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Katie Keyrouse · Cochlear

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Australia
  • Belgium
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05552118 on ClinicalTrials.gov