H90
Conditions
Interventions
Group 1: Patients with indication for cochlear implantation after the standardized assessment and planned surgery.
Study Procedures:
Before CI surgery:
- Inclusion of patient in CI therapy program (St
During CI electrode array insertion:
- The iotaSOFT ™ Insertion System will be used to insert the CI electrode array into the cochlea. During insertion, ECochG recordings will be conducted multiple ti
Sponsors
Universititätsspital
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: - signed written informed consent - Indication for cochlear implantation is given after the standardized assessment of the CI center at the University Hospital of Zurich - Surgery with a standard clinical CI system such as Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight or MED-EL Flex 24 & 28
Exclusion criteria
Exclusion criteria: - Vulnerable subjects - Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders or dementia of the subject - Craniofacial abnormalities, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g. fibrosis, fracture, or ossification), or cochlear malformations - Known or suspected non-compliance, drug or alcohol abuse - Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation - Previous enrolment into the current investigation on the same ear side (re-implantation) - Enrolment of the PI, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Correlation of changes in intra- and extracochlear ECochG signals during insertion of the CI electrode array into the cochlea, and 2) their correlation with acoustic hearing thresholds. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Correlation between ECochG patterns during robotic and manual CI electrode insertion, 2) correlation between clinical routine data recordings and ECochG patterns. | — |
Countries
Switzerland
Contacts
Public ContactAlexander Huber
Universitätsspital Zürich
Outcome results
None listed