Intended use
eXciteOSA® is intended for the reduction of snoring and mild obstructive sleep apnea by strengthening tongue muscles via electrical muscle stimulation
INDICATIONS FOR USE
eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.
ADDITIONAL CLINICIAN AND PATIENT INSTRUCTIONS FOR USE
- Patients should have a comprehensive dental examination prior to using this device to rule out cavities, dental implants, metal prosthesis, metal braces, dental appliances, and intraoral metallic jewelry/piercings.
- Patients should maintain regular follow-up visits with a Dentist and Sleep Health Professional.
- Patients should follow up with their sleep health clinician for a repeat Home Sleep Apnea Test after three months of therapy.
CLINICAL SUMMARY
- eXciteOSA® was used by 65 mild OSA patients, 20 minutes per day for 6 weeks, and 79% of group (51 patients) achieved an average reduction of 52% in AHI.
- eXciteOSA® was used by 115 snoring patients, 20 minutes per day for 6 weeks, and 90% of the group achieved an average reduction of 46% of time spent snoring.