An interventional study of Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants in Hearing Loss, Sensorineural and Hearing Loss, Bilateral, sponsored by Cochlear. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Cochlear · Not applicable, Interventional, and Supportive care
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.
Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation. The standard practice for this management involves frequent clinical visits in the first year after implantation and annual visits for the rest of the recipient's life. The need to travel to the clinic for follow up appointments can pose significant challenges for recipients, particularly those who live far away from the clinic. There have been reports of recipients being lost to follow up due to the difficulties in travelling to the clinic. The inconvenience of scheduling a session and travelling to the clinic might deter recipients from seeking help for some seemingly small / less troubling issues and increase their tendency to somehow bear and live with the issues. Sometimes clinicians schedule follow-up sessions with the primary purpose of following-up on progress with strategies provided earlier to overcome real world problems. Such follow-up on progress can easily be completed via a video call as well. Remote programming is one telehealth solution known to be successful in addressing the challenges of travelling to the clinic for appointments. During the Covid-19 pandemic there was a demonstrated increase in the uptake of remote programming when traveling to the clinic posed a health and safety risk. Current methods of remote programming of CI requires the use of special computer and programming hardware as well as proprietary programming software to be installed on a personal computer (PC) at the remote location. Although remote programming potentially reduces the travel burden for some recipients, it involves substantial administrative effort and cost by clinics to prepare, send, retrieve back, and clean remote programming hardware and software. This also reduces the frequency with which remote programming appointments can be scheduled due to time delays in sending and retrieving equipment. 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.
The current study aims to assess recipients ease and experience with using Remote Assist to receive remote programming of their CI.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.
Device: Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants
The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.
Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale)
Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.
Time frame: Immediately after the participants´ first use of the Nucleus Smart App with Remote Assist Custom Sound Pro 6.3, on average half an hour after participants have completed all tasks.
| Milestone | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.
| Participants | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale) | 13 |
Collected over One day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| Event | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Sound levels uncomfortably loudInvestigations | 1/15 |
| Age, Continuous(years) | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Median | 63 (44 to 90) |
| Sex: Female, Male(Participants) | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Female | 6 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|
| Region of Enrollment(participants) | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Australia | 15 |
| Age at test(years) | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 |
|---|---|
| Median | 63 (44 to 90) |
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