Clinical trial NCT06223724: Status Telemetry for Cochlear Implantations
Official title: Prospective Study of Status Telemetry for Cochlear Implantations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sensorineural Hearing Loss
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Linear error of electrode insertion depth estimation
timeFrame: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
measure: Linear error of electrode insertion depth estimation
timeFrame: At the additional post-operative CT scan (+3 months)
Secondary outcomes:
measure: Intra-operative progression of impedance subcomponents
timeFrame: During cochlear implantation (day 0)
measure: Post-operative progression of electrode insertion depth estimation
timeFrame: Recordings will be made during cochlear implant surgery (day 0) and at three follow-up visits (+2weeks, +4weeks, +12weeks).
measure: Angular error of electrode insertion depth estimation
timeFrame: At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
measure: Angular error of electrode insertion depth estimation
timeFrame: At the additional post-operative CT scan (+3 months)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
Study officials:
affiliation: Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery
name: Marco Caversaccio, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: