An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device

Exclusion Criteria

• •Subject with ear disease, ear trauma
• •Subjects with a bony abnormality (skull defect)
• •Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
• •Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
• •Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
• •For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
• •Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
• •Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)