Status Telemetry for Cochlear Implantations

NCT06223724 | Unknown

• 1 other identifier: PATHOS
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Intra-operative progression of impedance subcomponents

  During cochlear implantation (day 0)

• Post-operative progression of electrode insertion depth estimation

  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

  At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)

• Angular error of electrode insertion depth estimation

  At the additional post-operative CT scan (+3 months)

Study Arms (1)

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; Device: MAESTRO

Interventions

STOP DEVICE

Software to measure impedance telemetry data

Cochlear implant electrode insertion depth estimation

MAESTRO DEVICE

Software to measure impedance telemetry data

Cochlear implant electrode insertion depth estimation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects incapable of giving informed consent
• Age under 18 years
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery

Bern, 3008, Switzerland

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Caversaccio, Prof. Dr. med.

  Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Schraivogel, MSc

CONTACT

+41 31 632 76 15; stephan.schraivogel@unibe.ch

Wilhelm Wimmer, Prof.

CONTACT

wilhelm.wimmer@tum.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: January 25, 2024
• Study Start: October 25, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)