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Assessing usability of Remote Check on Android phones when used by adult cochlear implant recipients

A feasibility pilot, prospective, single centre, non-randomised, open-label, actual use testing study, assessing usability of Remote Check on Android phones when used by adult cochlear implant recipients.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000133831
Enrollment
15
Registered
2021-02-09
Start date
2020-11-05
Completion date
2020-12-07
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the feasibility pilot is to assess the ease of use of Remote Check on Android smart phones when used by adult Cochlear Implant recipients, in terms of usability and software issues, for the completion of primary tasks. Usability will be assessed using a ranking scale and questionnaire. Software issues/bugs relevant to the use of Remote Check on Android will be logged and used to inform any product enhancements required. The study will also characterise the test retest difference of Aided Threshold Test (AAT) and Digit Triplet Test (DTT) when streamed via Android smart phones.

Interventions

Remote Check is a feature of the Nucleus Smart App which comprises of various tests, performance measurements, datalogging, and a set of questions requiring a subjective answer by the recipient or parent/carer on sound quality and other aspects of device use. Remote Check is designed to be easy to use for a cochlear implant recipient even if they have no prior experience in using the Nucleus Smart App. No training will be provided to the participants on the use of the app; however, they will hav

Remote Check is a feature of the Nucleus Smart App which comprises of various tests, performance measurements, datalogging, and a set of questions requiring a subjective answer by the recipient or parent/carer on sound quality and other aspects of device use. Remote Check is designed to be easy to use for a cochlear implant recipient even if they have no prior experience in using the Nucleus Smart App. No training will be provided to the participants on the use of the app; however, they will have access to the guidance inbuilt in the app. Participants will have access to the Remote Check feature of the app on the loaner Android smartphone for the maximum duration of the trial (6 months). Remote Check in the Nucleus Smart App includes the following tests that can be run by the recipient or their parent/carer at home: photos of the implant site and surgical scar, questionnaire, Aided Threshold Test (ATT), Digit Triplet Test (DTT), Datalogs and Telemetry measurements. Results are intended to provide relevant information for a clinician to determine if the recipient needs to attend the clinic in-person or not. Primary tasks include participants identifying that a Remote Check is due in the Nucleus Smart App’s home screen, being able to start the Remote Check and proceed through the various tests as mentioned above. Remote Check activities in this trial are expected to take 1-2 hours in clinic and 1-2 hours at home. Remote Check is self-administered by the subject and results reviewed by a clinical audiologist. The results of the Remote Check will be accessed via a web-portal by the investigator to review data. In addition, the diagnostics logs from the app will be collected to assess use errors.

Sponsors

Cochlear Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Implanted with the below cochlear implants in one or both ears. CI500 series (CI512, CI513, CI522, CI532,), CI600 series (CI612, CI622, CI632), Freedom series (CI24RE (ST), CI24RE (CA), CI24RE (CS), CI422), N24 Series Implants: CI24R (CS), CI24R (CA), CI24R (ST), CI24M. 2. At least 3 months experience with the cochlear implant. 3. Able to complete open set speech perception test as judged by the investigator 4. Willing and able to provide written informed consent.

Exclusion criteria

1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 3. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation. 4. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026