Trials / Active Not Recruiting
Active Not RecruitingNCT05552118
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
A Post-Market, Prospective, Multi-Centre, Open-Label, Comparative, Interventional Study of Adult Cochlear Implant Speech Performance and Clinic Efficiency With Remote Care (Remote Check & Remote Assist) Compared With Standard of Care in the First 12 Months Post-initial Activation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-03-18
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2022-09-23
- Last updated
- 2026-01-16
Locations
11 sites across 5 countries: Australia, Belgium, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT05552118. Inclusion in this directory is not an endorsement.