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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleus Smart App with Remote Assist Custom Sound Pro 6.3 | Experimental | Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants | Device | The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Sydney In-house lab | Sydney | New South Wales | 2109 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 | Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2021 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 | Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Age at test | Median | Full Range | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nucleus Smart App With Remote Assist Custom Sound Pro 6.3 | Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors. 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. | 0 | 15 | 0 | 15 | 1 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sound levels uncomfortably loud | Investigations | Non-systematic Assessment | One participant experienced an adverse device effect (ADE) of sounds being uncomfortably loud when being programmed with RA. The Adverse event resolved when stimulation using the IMD was stopped |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear Limited | +612 9428 6555 | cltd-prs-admin@cochlear.com |
| Jul 10, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |
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