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

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural; Cochlear Implant
• Intervention / Treatment: Device: HearCare MED-EL App

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44787
    • Katholisches Klinikum Bochum
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HearCare MED-EL App; Subjects perform system check and install audio processor configuration via the HearCare MED-EL App	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Investigators: Principal Investigator: Andreas Büchner, Prof., Medizinsche Hochschule Hannover

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural
• Other Study ID Numbers: MED-EL_CRD_2023_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No