HS-1000An Evaluation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Patients After Concussion

Inclusion Criteria:

• Healthy subjects with no previous concussions:

1. Male or female subjects, aged 13 - 25 years old at screening visit
2. Subjects who were previously diagnosed by standard methods as healthy subjects with no previous concussions
3. Subject is able and willing to comply with the requirements of the protocol
4. Subject is able to understand and sign written informed consent to participate in the study

• Post-concussion diagnosed patients:

1. Male or female subjects, aged 13-25 years at screening visit
2. Subjects who were previously diagnosed by standard methods as suffering from concussion
3. Subject is able and willing to comply with the requirements of the protocol
4. Subject is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

1. Local ear infection
2. Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
3. 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)
4. 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
5. History of psychiatric illness, chemical dependency, Attention-Deficit Hyperactivity Disorder (ADHD), Learning Disability, seizure disorder, prior neurosurgical intervention
6. Current use of psychotropic medication