H90
Conditions
Interventions
Group 1: The outcome measures foreseen for this clinical investigation are the following:
• Stimulation report form
• Automatically recorded cymba conchae response upon and in absence of off-line filt
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Pre-scheduled for a routine cochlear implantation • Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation • High motivation with realistic expectations regarding the participation in this clinical investigation • Signed and dated informed consent before the start of any investigational procedure
Exclusion criteria
Exclusion criteria: • Lack of compliance with any inclusion criteria • Pregnant or breast-feeding women • Known allergies or intolerance to the material used for this clinical investigation • Suffering from comorbidities that may affect the results of this clinical investigation, such as CNS diseases • Current participation in other drugs and/or medical device clinical investigations that can confound the results of the present clinical investigation • Other clinical diseases that might result in alteration of the results of this clinical investigation • Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this clinical investigation is to determine whether the direct electrostimulation of the paVN elicits a measurable response of the cymba conchae. | — |
Secondary
| Measure | Time frame |
|---|---|
| This clinical investigation does not foresee secondary objectives. | — |
Countries
Austria
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed