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

NCT ID: NCT06173687

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-10-24

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.

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

All participants

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cochlear Macquarie

Sydney, New South Wales, Australia

HEARnet

Carlton, Victoria, Australia

ENT Department, Sint-Augutinus Antwerp

Wilrijk, Antwerp, Belgium

Cochlear Bone Anchored Solutions AB (CBAS)

Mölnlycke, Västergötland, Sweden

Countries

Australia; Belgium; Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AI5846

Identifier Type: -

Identifier Source: org_study_id