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

MED-EL

Status

Enrolling

Conditions

Cochlear Implant

Hearing Loss, Sensorineural

Treatments

Device: HearCare MED-EL App

Study type

Interventional

Funder types

Industry

Identifiers

NCT06543953

MED-EL_CRD_2023_01

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)