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Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

A Post-Market, Prospective, Multi-Centre, Open-Label, Comparative, Interventional Study of Adult Cochlear Implant Speech Performance and Clinic Efficiency With Remote Care (Remote Check & Remote Assist) Compared With Standard of Care in the First 12 Months Post-initial Activation

NCT05552118•Cochlear

View on ClinicalTrials.gov

Summary

The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years or older (no upper age limit)
•Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant
•Unilaterally implanted with a compatible Cochlear™ implant
•Currently using a compatible Cochlear™ Sound Processor
•3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements
•Direct access to a compatible Smart Phone
•Fluent in the languages used for the study, as determined by the investigator
•Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
•Willing and able to provide written informed consent

Exclusion Criteria

•Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming:
•* Non-monopolar MAPs (bipolar, common ground, variable mode)
•* Dynamic range of \<10 Comfortable Level (CL)
•* Hybrid mode enabled
•* Pulse widths \>100 µs
•* 10 or more electrodes turned off
•Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances
•Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation
•Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ)
•Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the Investigator
+5 more criteria

Locations (11)

Ear Science Institute Australia

Subiaco, Western Australia, Australia

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria

Bari, Italy

Azienda Ospedale Università di Padova

Padua, Italy

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Radboud University Medical Centre Nijmegen

Nijmegen, Netherlands

Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham

Birmingham, United Kingdom

Auditory Implant Centre, Glan Clwyd Hospital

Bodelwyddan, United Kingdom

St Thomas' Hospital

London, United Kingdom

Key Dates

Start Date

March 18, 2024

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

January 16, 2026

Enrollment

148

ESTIMATED participants

Conditions

Hearing Loss

Interventions

Cochlear™ Remote care

PROCEDURE

Standard of care

PROCEDURE

Compatible Implant Series and Compatible Sound Processors

DEVICE

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

NCT05668338

Hearing Loss

View study

RECRUITINGNA

Preschool Hearing Screening

NCT06058767

Hearing LossHearing Disorders in Children+6 more

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RECRUITINGNA

Evaluation of Flexible Conductive Hearing Aids

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

Inclusion Criteria

Exclusion Criteria

MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Preschool Hearing Screening

Evaluation of Flexible Conductive Hearing Aids

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