NCT06543953

Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Sensorineural
• Cochlear Implant

Interventions

Type	Name	Description
DEVICE	HearCare MED-EL App	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.

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2024-08-09
• Last updated: 2025-12-01

Locations

3 sites across 1 country: Germany