Status Telemetry for Cochlear Implantations (PATHOS)

Prospective Study of Status Telemetry for Cochlear Implantations

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.

Study Overview

• Status: Recruiting
• Conditions: Sensorineural Hearing Loss
• Intervention / Treatment: Device: STOP; Device: MAESTRO

• Study Type: Observational
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan Schraivogel, MSc; Phone Number: +41 31 632 76 15; Email: stephan.schraivogel@unibe.ch
• Study Contact Backup: Name: Wilhelm Wimmer, Prof.; Email: wilhelm.wimmer@tum.de

Study Locations

• Switzerland
  • Bern, Switzerland, 3008
    • Recruiting
    • Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects eligible for a MED-EL cochlear implant of the MED-EL portfolio (Flex series array) and who meet the additional inclusion/exclusion will be approached for participation in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: STOP; Software to measure impedance telemetry data; Device: MAESTRO; Software to measure impedance telemetry data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear error of electrode insertion depth estimation	Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.	At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Linear error of electrode insertion depth estimation	Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.	At the additional post-operative CT scan (+3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative progression of impedance subcomponents	Intra-operative measurement of access resistance and polarization impedance measured by the STOP software at several positions of the electrode array in the cochlea (stepwise insertion). The results will be expressed in kOhm (kΩ).	During cochlear implantation (day 0)
Post-operative progression of electrode insertion depth estimation	Post-operative cochlear implant electrode insertion depth estimation using a phenomenological model based on access resistance and polarization impedance measured by the STOP software after full insertion of the electrode array. The results will be expressed in kOhm (kΩ).	Recordings will be made during cochlear implant surgery (day 0) and at three follow-up visits (+2weeks, +4weeks, +12weeks).
Angular error of electrode insertion depth estimation	Angular error (in degrees) in impedance-based estimation of cochlear implant electrode insertion depth using a phenomenological model compared to ground truth from CT scans.	At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Angular error of electrode insertion depth estimation	Angular error (in degrees) in impedance-based estimation of cochlear implant electrode insertion depth using a phenomenological model compared to ground truth from CT scans.	At the additional post-operative CT scan (+3 months)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Marco Caversaccio, Prof. Dr. med., Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: PATHOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No