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Status Telemetry for Cochlear Implantations

NCT06223724 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-01-29

No results posted yet for this study

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

DEVICE

STOP

Software to measure impedance telemetry data

DEVICE

MAESTRO

Software to measure impedance telemetry data

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Marco Caversaccio, Prof. Dr. med. · Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2024-09-01
Completion
2024-10-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223724 on ClinicalTrials.gov