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Cochlear implants are a successful treatment for severe hearing loss in both children and adults. The procedure involves placing an electrode array into the cochlea to stimulate the auditory nerve, helping patients to hear. For the best results, it's crucial to place the electrode precisely and gently to avoid damaging delicate structures inside the ear. However, currently, surgeons lack feedback on the insertion status, making it difficult to confirm correct electrode positioning, especially regarding insertion depth, such as angle, frequency, or millimeters. New technologies are being developed to provide feedback during surgery, helping surgeons place the electrode more accurately. One such technology, recently developed by MED-EL, is called OTOGUIDE. This software offers immediate information on the electrode's position and functioning during the operation, aiming to improve surgical precision and hearing outcomes.
This clinical investigation aims to evaluate the performance and safety of OTOGUIDE, which assists surgeons during cochlear implant procedures by helping identify the position and angle of electrode contacts placed inside the cochlea. The primary objective is to confirm that OTOGUIDE can accurately detect which electrodes are inserted into the cochlea, with results that are more than 80% consistent with standard CT imaging (either during or after surgery). The secondary objective is to verify that OTOGUIDE can estimate the insertion angle of a specific electrode (C1) with a margin of error smaller than 60 degrees compared to CT imaging.
Participants who agree to take part and sign the informed consent form will undergo up to three study visit, which coincides with their scheduled routine cochlear implant surgery visits. During the Surgery Visit intraoperative measurements will be performed using both OTOGUIDE and the MAESTRO system. CT imaging (either during or after surgery, depending on routine clinical practice) will be used to verify the electrode array's position inside the cochlea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring electrode insertion with OTOGUIDE | Other | Monitoring electrode insertion with OTOGUIDE during routine cochlear implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTOGUIDE software | Device | OTOGUIDE performs objective measurements to enable the monitoring of the electrode insertion and the functioning of the electrode. OTOGUIDE guides the users through a workflow-based session to assess the implant status and to define a surgical approach. The users can plan an insertion target and monitor the real-time electrode insertion using an impedance-based method to automatically detect the number of contacts inside the cochlea. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of inserted electrodes | The primary endpoint is the agreement rate between OTOGUIDE and intra- or post-operative CT imaging in detecting which contacts in an electrode array are inserted and which are not inserted in the cochlea. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion angle of C1 electrode contact | The secondary endpoint is the deviation (i.e., the absolute difference) between the insertion angle for the C1 electrode contact estimated by OTOGUIDE and the insertion angle as assessed with intra- or post-operative CT imaging. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Deviation in Hz of the frequencies allocated to C1 - C12 electrode contacts | Deviation in Hz of the frequencies allocated to C1 - C12 electrode contacts as estimated by OTOGUIDE and the allocated frequencies as assessed with CT imaging | through study completion, an average of 1 year |
| Deviation in degree of the insertion angles of C2 - C12 electrode contacts |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmine Rinnofner | Contact | +43577881694 | jasmine.rinnofner@medel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
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This study has been planned as multi-center, prospective, one arm, within-subject control post-market study.
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Deviation in degree of the insertion angles of C2 - C12 electrode contacts estimated by OTOGUIDE and the insertion angles as assessed with intra-or post-operative CT imaging |
| through study completion, an average of 1 year |
| Intra-operative impedance values | Deviation in kΩ of the intra-operative impedance values derived from OTOGUIDE and MAESTRO | through study completion, an average of 1 year |
| Product-specific feedback | OTOGUIDE usability and satisfaction questionnaire for clinicians | through study completion, an average of 1 year |
| Klinikum der Universität München, Campus Großhadern Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde | Munich | Bavaria | 81377 | Germany |
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