Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

Exclusion Criteria

• •Local ear infection
• •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)