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This clinical investigation intends to assess safety and performance of the HearCare MED-EL App, a remote care option for recipients of MED-EL cochlear implants
Remote care solutions can provide cochlear implant users a greater convenience, accessibility, and personalized care. These advantages stem from the ability to fine-tune and adjust their devices from the comfort of their own environments, without the need for frequent and time-consuming in-person clinic visits.
Remote care allows clinicians to remotely assess data, provide guidance, and make necessary adjustments, all while minimizing the need for physical presence. This streamlined approach translates to increased capacity for serving a larger number of patients, ultimately leading to improved patient outcomes.
The HearCare MED-EL App is a mobile smartphone application designed for recipients of at least one compatible MED-EL cochlear implant and respective audio processor. The app manages technical checks on compatible cochlear implants and audio processors, creates and utilizes backups of audio processor configurations, and performs updates of audio processor configurations by acting as an executive organ of the MAESTRO System Software. The app reduces face-to-face follow-up appointments of users/caregivers with hearing professionals while maintaining safe and ongoing care for all individuals.
This clinical investigation aims to evaluate the HearCare MED-EL App regarding safety and performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HearCare MED-EL App | Other | Subjects perform system check and install audio processor configuration via the HearCare MED-EL App |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HearCare MED-EL App | Device | The main task of the HearCare MED-EL App is to perform technical checks on both implants and audio processors and create backups of audio processor configurations so that these configurations can be written on to an empty audio processor of the same type. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint to assess performance of the HearCare MED-EL App by installing a new audio processor configuration and performing a system check with the HearCare MED-EL App | The primary endpoint is success rate of the HearCare MED-EL app in percent for both the installation of new audio processor configurations and the detection of technical issues of audio processors or implants. | immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Speech test in quiet | Speech test in quiet results (Freiburg Monosyllables at 65 dB SPL) | immediately after the intervention |
| Speech test in noise | Speech test in noise results (adaptive SRT50 measured with Oldenburger Satztest (OLSA)) (optional) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Büchner, Prof. | Medizinsche Hochschule Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholisches Klinikum Bochum | Bochum | 44787 | Germany | |||
| Medizinische Hochschule Hannover |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| immediately after the intervention |
| Product specific questionnaire (for users) | Results of the product-specific user questionnaire (use of the App and satisfaction with the App). This questionnaire has various questions with different answer options (yes/no; amount of use; Likert scale, open text). Results to each question will be analyzed descriptively. | 2 months after the intervention |
| Product specific questionnaire (for professionals) | Results of the product-specific professional user questionnaire (satisfaction, performance, safety, and off-label use) by professionals. This questionnaire has various questions with different answer options (yes/no; amount of use; Likert scale, open text). Results to each question will be analyzed descriptively. | through study completion, an average of 2 years |
| Device parameters | Readout of device parameters stored in the devices internal memory/cloud services (e.g. log files, battery status, audio processor configurations, system check parameters, usage times) | immediately after the intervention |
| Incidents of device related adverse events | The safety profile of the HearCare MED-EL App will be evaluated through the analysis of device-related adverse events and in particular Unanticipated Serious Adverse Device Effect (USADE) assessment. | through study completion, an average of 2 years |
| Hanover |
| 30625 |
| Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |