Status:
COMPLETED
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Hearing Loss, Sensorineural
Cochlear Implant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06543953
Start Date
August 20 2024
End Date
November 26 2025
Last Update
December 1 2025
Active Locations (3)
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1
Katholisches Klinikum Bochum
Bochum, Germany, 44787
2
Medizinische Hochschule Hannover
Hanover, Germany, 30625
3
Universitätsklinikum Würzburg
Würzburg, Germany, 97080