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

NCT06543953 | Completed

• 1 other identifier: MED-EL_CRD_2023_01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Conditions

Hearing Loss, Sensorineural; Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Speech test in quiet

  immediately after the intervention

• Speech test in noise

  immediately after the intervention

• Product specific questionnaire (for users)

  2 months after the intervention

• Product specific questionnaire (for professionals)

  through study completion, an average of 2 years

• Device parameters

  immediately after the intervention

Study Arms (1)

HearCare MED-EL App

OTHER

Subjects perform system check and install audio processor configuration via the HearCare MED-EL App

Device: HearCare MED-EL App

Interventions

HearCare MED-EL App DEVICE

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.

HearCare MED-EL App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (3)

Katholisches Klinikum Bochum

Bochum, 44787, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Büchner, Prof.

  Medizinsche Hochschule Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: August 9, 2024
• Study Start: August 20, 2024
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

DE (3)