H83
Conditions
Interventions
Group 1: Electrode Array Insertion Assisted by Otoarm/Otodrive
Group 2: Conventional Manual Electrode Array Insertion
Sponsors
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - German as native language - postlingual deafness - implantation with FLEXsoft electrode array (MED-EL) possible
Exclusion criteria
Exclusion criteria: -active neurological/psychiatric diagnoses - vestibular schwannoma - meningitis - labyrinthitis - cochlear malformation - cochleostomy - inability to comply with study instructions - inability to receive implantation with the FLEXsoft electrode array (MED-EL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual hearing preservation (measured at 125, 250, and 500 Hz, 1 month after intervention) and speech perception (assessed using the Freiburg monosyllabic test, with follow-up up to 7 months after intervention), as well as vestibular function (evaluated by vHIT, cVEMP, oVEMP, DHI, and VRBQ, with follow-up up to 7 months after intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrophysiological parameters (impedances, transimpedance matrix, evoked potentials, ECochG), tinnitus-related measures (THI, VAS, Mini-TQ-15), anatomical changes (pre- and postoperative CT/MRI), and intraoperative process parameters (insertion duration, surgery time, surgeon satisfaction, and cognitive/muscular workload), all of which are recorded and compared | — |
Countries
Germany
Contacts
Public ContactRobert Mlynski
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"
Outcome results
None listed