Clinical trial NCT06543953: Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
Official title: Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Cochlear Implant
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Speech test in quiet
timeFrame: immediately after the intervention
measure: Speech test in noise
timeFrame: immediately after the intervention
measure: Product specific questionnaire (for users)
timeFrame: 2 months after the intervention
measure: Product specific questionnaire (for professionals)
timeFrame: through study completion, an average of 2 years
measure: Device parameters
timeFrame: immediately after the intervention
measure: Incidents of device related adverse events
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: Medizinsche Hochschule Hannover
name: Andreas Büchner, Prof.
role: PRINCIPAL_INVESTIGATOR
References: