CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implantsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04987021
NCT04987021N/ACompleted

An Actual Use, Prospective, Adaptive Design, Single Centre, Non-randomised, Open-label Study, Assessing Usability of Remote Assist When Used to Program Cochlear Implant Recipients

Cochlear·interventional·Posted Aug 3, 2021·Updated Feb 21, 2024

In Brief

A clinical study evaluating Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants for Hearing Loss, Sensorineural and Hearing Loss, Bilateral. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation. This requires the recipients to travel to the clinic for follow up appointments which can pose significant challenges for recipients, particularly those who live far away from the clinic. Remote Assist (RA) is a new solution that allows the clinician to make MAP and sound processor adjustments via the recipient's Nucleus Smart app (NSA) installed on their smart phone. With RA the clinician can also perform counselling using a video call directly via the NSA. As RA uses no specialized hardware and software that needs to be sent and retrieved back from the recipient, it has the potential to further improve the remote programming experience and convenience for both the recipient and the clinician.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 3, 2021
Enrollment StartAug 27, 2021
Primary CompletionJan 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.9 years ago

Interventions

Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implantsdevice

The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.