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

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.

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)