PoNS Clinical Experience Program (TBI)

Criteria for Inclusion/Exclusion:

Subjects must present with a chronic balance deficit due to mild-to-moderate TBI. However,
other potentially related symptoms, such as gait disturbance, mild to moderate recurrent
headaches, sleep, memory, attention, and cognitive deficits, will be noted on the data
collection form at screening and each subsequent evaluation.

Inclusion Criteria: Subjects must meet all of the following criteria to be included in the
study:

1. At least 18 years of age, inclusive, at the time of screening.

2. Acceptable results (as determined by the investigator) of a full history and physical
performed or supervised by the investigator at each site. This will include a careful
examination of the tongue and oral cavity for any abnormalities. History should
include the nature and duration of any prior physical therapy program the subject may
have participated in to address the balance and/or gait symptoms of their TBI. Prior
participation in therapy is not a prerequisite for enrollment in the program

3. Documentation on the history of a qualifying TBI, mild to moderate in severity. For
reference, the Armed Forces Health Surveillance Branch (AFHSB) definitions of mild and
moderate TBI will be used. The definitions are as follows:

4. Mild TBI: Confused or disoriented state which lasts less than 24 hours; or loss of
consciousness for up to 30 minutes, or memory loss lasting less than 24 hours.
Excludes penetrating TBI.

5. Moderate TBI: Confused or disoriented state which lasts more than 24 hours; and/or
loss of consciousness for more than 30 minutes but less than 24 hours, or memory loss
lasting greater than 24 hours but less than seven days; or meets criteria for Mild TBI
except an abnormal CT scan is present. Excludes penetrating TBI.

The investigator will ascertain whether the prior medical records and information
collected during the clinical interview are sufficiently detailed to support the
classification of the TBI.

6. Acceptable results from within the last three (3) months as determined by the site
investigator of basic standard blood work to include CBC, TSH, HbA1C, Liver and Kidney
panels, and a 12-lead ECG with automated reporting capability. Any abnormal result
that is judged clinically significant by the investigator will be communicated to the
subject and if treated by their personal physician and deemed recovered, the subjects
may be reconsidered for inclusion. If the investigator is uncertain he or she will
communicate with the Sponsor's Medical Officer.

7. If female, the subject is not pregnant, not breastfeeding and has a negative pregnancy
test prior to receipt of the PoNS device

- Note: Pregnancy testing will be repeated at end-of-study (EOS) (i.e., end of at-home
period).

8. If female is of childbearing potential, the subject agrees to use adequate
contraception from screening and throughout the study period.

A female of non-childbearing potential is defined as a subject who is postmenopausal
(continuous amenorrhea for 12 months) or surgically sterile (defined as bilateral
tubal ligation, bilateral oophorectomy, or hysterectomy).

9. Balance disorder as indicated by the NeuroCom® Sensory Organization Test (SOT)
composite score at least 16 points below normal [adjusted for age and height, based on
normative data] due to a mild-to-moderate traumatic brain injury (TBI).

10. At least three (3) months post most recent TBI at the time of screening.

11. Stable neurologic status, as determined from subject's medical records and the study
physician's opinion based on no new or changing symptoms.

12. Qualifying MRI report to be entered into the data collection form. For all
participants who do not have a qualifying MRI, a new MRI will be obtained.

13. Ambulatory and able to walk continuously over-ground or on a treadmill for 20 minutes,
level grade (no inclination) and at any speed, with support, if needed.

14. Able to understand the study procedures and give informed consent.

15. Willing and able to adhere to the study schedule.

16. Willing to complete a neuropsychological evaluation if deemed necessary by the
investigator prior to inclusion in the study.

Exclusion Criteria: Subjects meeting any of the following criteria will be excluded
from the study:

17. Medical findings from screening history, physical examination or radiological test
that the investigator deems clinically significant or that would otherwise impact
patient safety or data integrity.

2. Planned use or use of any investigational product (i.e., not approved by the FDA),
pharmaceutical or device, within 30 days preceding receipt of the PoNS device and during
the entire period of subject participation.

3. Any previous use of the Portable Neuromodulation Stimulator (PoNS)

4. Balance or gait deficits due to lower extremity injury or neurological condition other
than TBI.

5. Severe TBI defined as an injury with a confused or disoriented state which lasts more
than 24 hours; and/or loss of consciousness for more than 24 hours, or memory loss for more
than seven days.

6. Penetrating brain injury, refractory subdural hematoma, tumor, other space occupying
lesion, arteriovenous malformation or craniotomy unrelated to the resolution of qualifying
traumatic brain injury. Investigator discretion may be exercised on an individual case
where surgery was performed that did not remove or significantly alter brain tissue (e.g.,
to treat a brain aneurysm). Surgery must have been performed at least 6 months prior to
screening and a CT scan must be provided to demonstrate no large residual lesions.

7. Oral health problems active at the time of recruitment. Any history of oral health
problems (e.g., gum disease or cankers) will be noted on the data collection form.

8. Oral surgery within 3 months of screening. 9. History of oral cancer. 10. Non-removable
metal orthodontic devices (e.g., braces) or oral cavity piercings that could interfere with
PoNS use.

11. Presence of metallic implant or other MRI-incompatible device. 12. Known allergy to
gold, nickel or copper. 13. Blood pressure abnormalities considered clinically significant
by the study physician. If the subject has an average systolic blood pressure of <100 mmHg,
they will be evaluated for orthostatic hypotension and if the investigator deems this a
risk for the subject's health or safety they will be excluded. If systolic blood pressure
>160 mm Hg (average of 3 measurements) at screening and the subject is on medications, the
subject will be re-evaluated once the treating physician deems them to have stable blood
pressure.

- Note: BP should be measured seated, legs uncrossed, after resting for 5 minutes, with
measurements taken 2 minutes apart. Two BP readings should be taken and averaged. If
the first two readings differ by >5 mm Hg, a third measurement should be taken and an
average calculated for all 3 values.

14. Use of Coumadin or any other anticoagulant other than aspirin in the last six
months.

15. Untreated or undiagnosed diabetes - the subject will be referred to their family
physician and may be re-evaluated at a later date. Undiagnosed diabetes is defined as
an HbA1C taken during screening above the upper limit of normal at the study site.

16. Diabetic neuropathy. 17. Active or recent (within 1 year) treatment for any
cancer, excluding basal cell carcinoma.

18. Neurological disorders other than those attributed to the primary diagnosis,
(e.g., neurodegenerative diseases such as Multiple Sclerosis (MS), Parkinson's disease
(PD), Alzheimer's disease (AD) or other dementia, Amyotrophic Lateral Sclerosis (ALS).

19. History of epileptic or other seizure disorders. 20. Known ischemic heart disease
(angina, stent, history of myocardial infarction, >70% stenosis or cardiovascular
imaging) and/or history or atrial or ventricular arrhythmias with or without syncope.
Any abnormality on the screening ECG will be referred to the subject's family
physician for evaluation and clearance and then the subject can be re-evaluated for
inclusion in the study.

21. Any other untreated or unstable acute or chronic, clinically significant medical
condition for which the subject is currently undergoing treatment (e.g., autoimmune or
immunodeficient disorders) and that the investigator deems unsuitable for inclusion.

22. Use of a lower extremity biomechanical prosthetic with the exception of a splint
to address foot drop.

23. Chronic use of any potentially interfering drug such as a neuroactive (ototoxic,
anti-seizure, anti-convulsive) medication, or chronic/PRN use of any medication that
would, in the opinion of the investigator, compromise the subject's ability to
function or perform the study activities.

24. Addition of and/or major change in type or dosage of any prescription medication
within 3 months prior to receipt of the PoNS device at the time of screening, subject
to physician discretion.

25. Active alcoholism documented by the investigator at the time of screening. The
investigator will have the right to exclude subject participation if, in their
opinion, the subject seems intoxicated at time of screening and/or during any study
appointment.

26. History of drug abuse as documented by the investigator at the time of screening.
The investigator will have the right to exclude subject participation if, in their
opinion, the subject seems intoxicated at time of screening or presentation for
treatment 27. Recent (6 months) history of smokeless tobacco use (i.e., chewing
tobacco, oral tobacco, spit or spitting tobacco, dip, chew, snuff*) (*NCI definition)

- Note: Cigarette, cigar, pipe, and/or e-cigarette use is not exclusionary 28. Any
reason, considered by the principal investigator or designee to preclude subject
enrollment in the study that might represent a threat to health, safety, or an
inability to comply with the study protocol.

29. Subject is incompatible with the device. 30. Subject is currently in a focused
physical rehabilitation program for balance or gait symptoms resulting from their TBI
and has not been deemed by their treating clinician to have reached a plateau.