NCT06223724

Status Telemetry for Cochlear Implantations

Prospective Study of Status Telemetry for Cochlear Implantations

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DEVICE	STOP	Software to measure impedance telemetry data
DEVICE	MAESTRO	Software to measure impedance telemetry data

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2024-01-25
• Last updated: 2024-01-29

Locations

1 site across 1 country: Switzerland