H90
Conditions
Interventions
Group 1: During a regular CI surgery, an access point to the stapedius muscle is created and an EMG electrode is placed in the muscle. Depending on the type of electrode a second reference electrode i
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Measurable acoustical stimulation of the Stapedius reflex • Need of a 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 • Current participation in other drugs and/or medical device clinical investigations that can affect 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 following parameters are evaluated: Activation of the stapedius reflex, measured by using • EMG • Video Occurrence of adverse events. | — |
Countries
Germany
Contacts
Public ContactVerena Rieger
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed