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 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.

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.

Eligibility

Relevant conditions:

Hearing Loss

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

Taike Bruyneel

tbruyneel@cochlear.com

003216795564

Data sourced from ClinicalTrials.gov