The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.

The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).

Inclusion Criteria:

1. Subject is >18 years of age
2. Subject has had moderate to severe symptoms of nasal congestion for >3 months (TNSS rating of 2 or 3)
3. Subject has signed IRB-approved informed consent form

Exclusion Criteria:

1. Subject has neurologic comorbidities
2. Subject has active dental infection
3. Subject is pregnant
4. Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
5. Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
6. Subject has been diagnosed with intracranial hemorrhage within the last 6 months
7. Subject has open scalp wounds or rashes
8. Subject has any history of craniotomy without replacement of a bone flap
9. Subject has elevated sensitivity to sound
10. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

Adult subjects with nasal congestion

1 day, acute study

Adverse event definition is same as clinicaltrials.gov definition. Adverse events were collected for all 50 participants