Exploratory assessment of a minimally invasive setting to measure evoked potentials elicited by stimulation of the posterior auricular branch of the Vagus nerve within a prescheduled Cochlear implantation surgery

Not Applicable

Conditions: H90
Conductive and sensorineural hearing loss

Registration Number: DRKS00025817

Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting withdrawn before recruiting started

Sex: All

Target Recruitment: 10

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

• 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim of this clinical investigation is to determine whether the direct electrostimulation of the paVN elicits a measurable response of the cymba conchae.<br>

Secondary Outcome Measures