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.