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

Last updated: November 21, 2024
Sponsor: Cochlear
Overall Status: Completed

Phase

N/A

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

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

Clinical Study ID

NCT06173687
AI5846
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older (no upper age limit).

  • Implanted with CIC4-based implant with a Contour Advance, Slim Straight or SlimModiolar electrode array with at least 6 months experience.

  • Candidate is a fluent speaker in the language used to assess speech perceptionperformance, as determined by the investigator.

  • Willing and able to provide written informed consent.

Exclusion

Exclusion Criteria:

  • Score below 3 on the screening subset of questions from the Mobile DeviceProficiency 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 restrictparticipation in the evaluations, including significant visual impairment and/ordexterity issues.

  • Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator.

  • Investigator site personnel directly affiliated with this study and/or theirimmediate families; immediate family is defined as a spouse, parent, child, orsibling.

  • Cochlear employees or employees of Contract Research Organisations or contractorsengaged by Cochlear for the purposes of this investigation.

  • Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessthe other investigation was/is a Cochlear sponsored investigation and determined bythe investigator or Sponsor to not impact this investigation)

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: The impedance measurement task using the Mobile Research App (MRA)
Phase:
Study Start date:
January 29, 2024
Estimated Completion Date:
October 24, 2024

Study 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.

Connect with a study center

  • Cochlear Macquarie

    Sydney, New South Wales 2109
    Australia

    Site Not Available

  • HEARnet

    Carlton, Victoria 3052
    Australia

    Site Not Available

  • ENT Department, Sint-Augutinus Antwerp

    Wilrijk, Antwerp 2610
    Belgium

    Site Not Available

  • Cochlear Bone Anchored Solutions AB (CBAS)

    Mölnlycke, Västergötland 43533
    Sweden

    Site Not Available

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