Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| QbD Clinical | INDUSTRY |
| Avania | INDUSTRY |
| TFS | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear™ Remote care | Experimental | Is composed of Cochlear™ Remote Check and Cochlear™ Remote Assist. |
|
| Standard of care | Active Comparator | Routine In-clinic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear™ Remote care | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation | Measuring change of speech, spatial and hearing experiences (12 items). Each item is scored on a scale of 0 to 10 where 0 corresponds to "complete inability or complete absence of a quality" and 10 to "complete ability or complete presence of an ability". The score of a participant is determined as the mean of the 12 items. Higher scores indicate less hearing disability | 3 months post-activation (baseline) and 12 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in speech recognition score for an open-set word recognition measure in quiet between 3 months post-activation (baseline) and 12 months post-activation | The test is done using phonetically balanced words and scores are recorded as % correct words. Higher scores indicate a better outcome. | 3 months post-activation (baseline) and 12 months post-activation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:
Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances
Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation
Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the Investigator
Additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katie Keyrouse | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ear Science Institute Australia | Subiaco | Western Australia | 6008 | Australia | ||
| UZ Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41120152 | Derived | Quaranta N, Murri A, Denys S, Verhaert N, Huinck W, Townsend J, Swinnen F, Dhooge I, de Klerk A, Mehta D, Brotto D, Craddock L, Hoskam G, Schou IM, McBride ME, Campbell-Bell C. Randomised controlled trial to assess the efficiency and effectiveness of remote care compared with in-clinic care for adult cochlear implant recipients in the first 12 months after activation: a protocol of the INSPIRE study. BMJ Open. 2025 Oct 20;15(10):e094283. doi: 10.1136/bmjopen-2024-094283. |
Not provided
Not provided
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of care | Procedure | Routine in clinic face-to-face care and sound processor programming using Cochlear™ Custom Sound® Pro |
|
| Compatible Implant Series and Compatible Sound Processors | Device | Individuals who are implanted with a compatible cochlear implant series and compatible sound processor are eligible to participate. |
|
| Mean change in speech recognition score for sentences in adaptive noise between 3 months post-activation (baseline) and 12 months post-activation | The test is done using validated lists of phonetically balanced sentences. The noise is kept constant at 65 decibel (dB) Sound Pressure Level (SPL), and the speech is adapted stepwise to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. Lower scores indicate a better outcome. | 3 months post-activation (baseline) and 12 months post-activation |
| Descriptive summaries of clinic time and resource utilisation incurred between 3 months and 12 months post-activation assessed via a custom questionnaire. | 3 months post-activation (baseline) and 12 months post-activation |
| Descriptive summaries of time and costs incurred by participants between 3 months and 12 months post-activation via a custom questionnaire | 3 months post-activation (baseline) and 12 months post-activation |
| Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ)-8 at 12 months post-activation | Measuring satisfaction of participants with the healthcare service (8 questions). Each item is scored using a 4-point Likert scale with 1 always indicating a negative response and 4 a positive response. A total higher score indicates higher satisfaction | 12 months post-activation |
| Participant empowerment measured with the Patient Activation Measure (PAM), at 12 months post-activation | Evaluating the knowledge, skills, beliefs, and behaviours that participants have for self-management of their long-term health condition (13 items). Each item is scored on a 4-point likert scale from 1 (strongly disagree) to 4 (strongly agree). The overall score is calculated and normalized to a 100-point scale. Higher scores indicate greater levels of activation. | 12 months post-activation |
| Ghent |
| 9000 |
| Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria | Bari | 70120 | Italy |
| Azienda Ospedale Università di Padova | Padova | 35128 | Italy |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 EV | Netherlands |
| Radboud University Medical Centre Nijmegen | Nijmegen | 6500 HB | Netherlands |
| Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham | Birmingham | B15 2TH | United Kingdom |
| Auditory Implant Centre, Glan Clwyd Hospital | Bodelwyddan | LL18 5UJ | United Kingdom |
| St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided