Evaluating a mobile app for cochlear implant users
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
NA · MED-EL Elektromedizinische Geräte GesmbH · NCT06543953
This study tests a new mobile app that helps people with MED-EL cochlear implants manage their devices from home to see if it makes their care easier and more convenient.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH (industry) |
| Locations | 3 sites (Bochum and 2 other locations) |
| Trial ID | NCT06543953 on ClinicalTrials.gov |
What this trial studies
This clinical investigation assesses the safety and performance of the HearCare MED-EL App, which offers remote care solutions for recipients of MED-EL cochlear implants. The app allows users to manage their cochlear devices from home, reducing the need for in-person clinic visits. By enabling clinicians to remotely monitor and adjust devices, the app aims to enhance patient convenience and accessibility while improving overall care. The study will evaluate how effectively the app can support cochlear implant users in managing their hearing devices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 who have been implanted with at least one MED-EL cochlear implant for at least three months and are using a compatible audio processor.
Not a fit: Patients who have not been implanted with a compatible MED-EL cochlear implant or those with specific medical conditions that prevent app usage may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could significantly improve the convenience and quality of care for cochlear implant recipients.
How similar studies have performed: Other studies have shown promise in using remote care solutions for cochlear implant users, indicating a positive trend in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Implanted with at least one MED-EL Cochlea Implant (CI) for at least 3 months * Fitted with at least one audio processor compatible with the HearCare MED-EL App (i.e. SONNET 2, SONNET 2 EAS, RONDO 3 or newer) * Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure Exclusion Criteria: * Lack of compliance with any inclusion criteria * Implanted with C40X and C40C * Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array * Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study (e.g. psychological disorders, neurologic or motoric comorbidity that could restrict subjects from using the app)
Where this trial is running
Bochum and 2 other locations
- Katholisches Klinikum Bochum — Bochum, Germany (NOT_YET_RECRUITING)
- Medizinische Hochschule Hannover — Hannover, Germany (RECRUITING)
- Universitätsklinikum Würzburg — Würzburg, Germany (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Andreas Büchner, Prof. — Medizinsche Hochschule Hannover
- Study coordinator: Jasmine Rinnofner
- Email: studies@medel.com
- Phone: +43 57788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Sensorineural, Cochlear Implant