Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant (DICE)

Feasibility, Prospective, Multicentric, Cross-sectional Investigation to Characterize Daily Impedance Fluctuations and Satisfaction in Challenging Listening Environments in Experienced Adult CI Recipients Using the Mobile Research App (MRA)

This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. Improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: The impedance measurement task using the Mobile Research App (MRA)

Detailed Description

This is a feasibility, prospective, multi-country, multi-centre, cross-sectional interventional clinical investigation in adults with a CE labelled cochlear implant.

No Randomisation nor blinding to avoid bias is applicable in this study since there is no comparator.

Subjects will attend two scheduled study visits over a two-month study period. At and in between study visits, subjects will undergo hearing assessments and safety monitoring. The subjects will perform daily impedance test tasks and complete a questionnaire in order to obtain the first primary endpoint, i.e. characterization of Daily Impedance Fluctuations.

Furthermore, the subjects will do EMA tasks to obtain the secondary objectives to capture daily-life, real-world listening environments and challenging listening environments.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2109
      • Cochlear Macquarie
  • Victoria
    • Carlton, Victoria, Australia, 3052
      • HEARnet
• Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • ENT Department, Sint-Augutinus Antwerp
• Sweden
  • Västergötland
    • Mölnlycke, Västergötland, Sweden, 43533
      • Cochlear Bone Anchored Solutions AB (CBAS)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged 18 years or older (no upper age limit).
• Implanted with CIC4-based implant with a Contour Advance, Slim Straight or Slim Modiolar electrode array with at least 6 months experience.
• Candidate is a fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (digital literacy check).
• A failed ECE1 or ECE2 (i.e. flagged, open circuit or short circuit)
• Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants	Device: The impedance measurement task using the Mobile Research App (MRA); Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impedance Measurements	Median of the standard deviation in total electrode impedance (measured in kOhm, averaged across 22 electrode contacts) between days for 8 weeks.	8 Weeks

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): October 24, 2024
• Study Completion (Actual): October 24, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 20, 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 Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: AI5846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No