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

NCT06173687 | Completed Results

• 1 other identifier: AI5846
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All participants

EXPERIMENTAL

Device: The impedance measurement task using the Mobile Research App (MRA)

Interventions

The impedance measurement task using the Mobile Research App (MRA) DEVICE

Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.

All participants

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cochlear: lead

Study Sites (4)

Cochlear Macquarie

Sydney, New South Wales, 2109, Australia

Location

HEARnet

Carlton, Victoria, 3052, Australia

Location

ENT Department, Sint-Augutinus Antwerp

Wilrijk, Antwerp, 2610, Belgium

Location

Cochlear Bone Anchored Solutions AB (CBAS)

Mölnlycke, Västergötland, 43533, Sweden

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: PRS Specialist
• Organization: Cochlear Limited

cltd-prs-admin@cochlear.com

+612 9428 6555

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: December 18, 2023
• Study Start: January 29, 2024
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); BE (1); SE (1)