Features
- Flexible silicone mouthpiece with electrodes that positions on the tongue
- Mouthpiece USB-C type connector fits into the Bluetooth enabled power source and control electronics unit that is controlled by smartphone application
- eXciteOSA smartphone App lets you know in advance when to replace mouthpiece
- Replacement mouthpiece facilitates twice weekly maintenance therapy with eXciteOSA
This Product Includes
- Mouthpiece (flexible silicone with electrodes) with USB-C type connector*
*Mouthpiece must be replaced approximately every 90 days requiring a separate purchase.
Contraindications*
Do not use eXciteOSA if you:
- Are younger than 18 years old
- Are pregnant or may be pregnant
- Have a pacemaker or implanted electrodes
- Have temporary or permanent metal implants, dental braces, intraoral metal prosthesis/restorations/appliances or dental jewelry in the mouth
- Are suffering from mouth ulcers
- Have or are suspected of having an AHI > or = to 15/hr. during a sleep study as determined by evaluation of a sleep health professional
*Safety and effectiveness in the above conditions have not been established.
Specifications
PRODUCT SPECIFICATIONS
Product Name eXciteOSA® Replacement Mouthpiece
Manufactured By Signifier Medical Technologies
Packaging Includes Mouthpiece
Country of Manufacturing EU
Part Number 16000
Intended Use eXciteOSA® is intended for the reduction of snoring and mild obstructive sleep apnea by strengthening tongue muscles via electronical muscle stimulation.
Frequency of Use It is recommended you use eXciteOSA® once daily for a continuous 20 minutes. It can take up to 6 weeks of daily therapy before you will gain the desired improvement in your snoring and mild OSA. Once the desired results are achieved, it is recommended to have a twice-a-week regular maintenance regime. eXciteOSA® can be used long term. This is comparable to maintaining your physical fitness by undertaking regular exercise. You must replace the Mouthpiece after 90 calendar days of first use, this includes the maintenance period.
Precaution The silicone on the Mouthpiece must be intact before use. If there is any breach of the silicone (including electrodes) – DO NOT USE THE MOUTHPIECE.
Operational Requirements Temperature +41°F to +104°F (+5°C to +40°C); Humidity 15% to 90%; Atmospheric Pressure 10.15 psi to
15.37 psi (70 kPa to 106 kPa). Operational life is 3 years.
Transport and Storage Requirements
Temperature -13°F to +158°F (-25°C to +70°C); Humidity up to 90%
Atmospheric Pressure 10.15 psi to 15.37 psi (70 kPa to 106 kPa). When the device is exposed to extreme
temperatures, please wait at least 60 minutes before attempting to use the device.
Warranty 3 months for the eXciteOSA® Mouthpiece from the date of purchase
Prescription Information Prescription required by licensed physician to purchase this item
HCPCS Code K1029
Reimbursement Typically not reimbursable with highly variable exceptions.
