A User Study of SYNUS Pain Relief Made by Tivic Health Systems

A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30
of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that
uses micro-currents to stimulate major nerve fibers passing from the sinus passages through
various foramina to the facial skin. Subjects will read manufacturer's provided
Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the
treatment. The other subjects will follow the same procedure but use a sham/placebo device
with no stimulating current. Subjects will be blinded as to the device they use. Prior to and
10 minutes following the stimulation, subjects will score their pain level on a visual
analogue scale.

Inclusion Criteria:

- Be 18 years of age and older

- Present with symptoms of sinus pain and pressure

- Have an initial sinus pain score of 4 or more on the visual analogue scale

- Be able to read and understand English

- Agree to participate in the study

- Be able and willing to provide Informed Consent

Exclusion Criteria:

- Do not meet Inclusion Criteria

- Have currently a dental infection

- Have currently abnormal cranial nerve or other neurological findings or symptoms that
would require prompt medical attention

- Be currently pregnant

- Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear
implant