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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STOP | Device | Software to measure impedance telemetry data |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan Schraivogel, MSc | Contact | +41 31 632 76 15 | stephan.schraivogel@unibe.ch | |
| Wilhelm Wimmer, Prof. | Contact | wilhelm.wimmer@tum.de |
| Name | Affiliation | Role |
|---|---|---|
| Marco Caversaccio, Prof. Dr. med. | Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery | Recruiting | Bern | 3008 | Switzerland |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| MAESTRO | Device | Software to measure impedance telemetry data |
|
| 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) |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |