Status Telemetry for Cochlear Implantations

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check the position of electrodes in cochlear implants, which are devices that help people with hearing loss. Normally, doctors use a type of imaging called a CT scan to see where the electrodes are placed, but this can be costly and expose patients to radiation, which can be especially harmful for children. Instead, this study is exploring a method that uses impedance telemetry data, an advanced technology that can estimate the position of the electrodes without using radiation. The goal is to improve hearing outcomes for those receiving cochlear implants while keeping patients safe from unnecessary exposure.

To participate in this trial, individuals must be at least 18 years old and scheduled for cochlear implant surgery using specific devices from the MED-EL portfolio. Participants will need to give their consent and agree to follow the study procedures. Throughout the study, they can expect to undergo the usual surgical process but will also be part of a research effort aimed at enhancing the effectiveness of cochlear implants. This trial is currently recruiting participants, and everyone's contribution will help in finding safer and better treatment options for those with hearing loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent signed by the subject
• • Subjects scheduled for CI surgery according to clinical routine
• • Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
• • No radiological contraindications
• • Stated willingness to comply with all study procedures for the duration of the study
• Exclusion Criteria:
• • Lack of compliance with any inclusion criteria
• • Subjects incapable of giving informed consent
• • Age under 18 years
• • Pregnancy

Trial Officials