Prospective Study of Status Telemetry for Cochlear Implantations

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children. This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software. Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
RECRUITING
Bern
Contact Information
Primary
Stephan Schraivogel, MSc
stephan.schraivogel@unibe.ch
+41 31 632 76 15
Backup
Wilhelm Wimmer, Prof.
wilhelm.wimmer@tum.de
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2024-10-01
Participants
Target number of participants: 20
Treatments
Cochlear implant electrode insertion depth estimation
Electrode insertion depth estimation using impedance telemetry data measured during cochlear implantation and at three regular follow-up visits
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov