Bongo RX EPAP Device with Headgear

How does Bongo Rx work?
Bongo Rx is very small and simple to use. Bongo Rx does not require a machine, mask, hose, electricity, or even batteries. You simply place the Bongo Rx airway dilators just inside your nostrils where the soft silicone device seals the nasal passages. Your own breathing activates the device. During inhalation, small valves open to allow you to breathe in normally through the device. Then, during exhalation, the valves close, directing the exhaled air through specifically designed vent holes to create back pressure to keep your airway open until you inhale again. Creating back pressure during exhalation is also known as EPAP (Expiratory Positive Airway Pressure).

How is Bongo Rx different from CPAP therapy?
Continuous Positive Airway Pressure (CPAP) creates pressure continuously during both inhalation and exhalation. The Bongo Rx device creates pressure only on exhalation. CPAP uses forced air generated by an electrical machine, while Bongo Rx uses the patient’s own breathing to generate back pressure. CPAP therapy typically requires a CPAP machine, a humidifier, a hose, and a bulky mask that must be tightened down. Bongo Rx is simply inserted just inside the nostrils and requires no machine or power. For those who cannot tolerate CPAP, cannot get or afford CPAP, or do not want to try CPAP, Bongo Rx may be an effective CPAP alternative.

Is Bongo Rx FDA cleared?
Yes, Bongo Rx has been reviewed and cleared by the U.S. Food and Drug Administration (FDA) for use in the treatment of mild to moderate obstructive sleep apnea (OSA). In the U.S., all devices intended to treat sleep apnea are considered class II medical devices and must be reviewed and cleared by the FDA specifically for treating sleep apnea (not just for treating snoring).

Has Bongo Rx been clinically tested?
Yes, clinical testing was conducted to demonstrate the safety and effectiveness of Bongo Rx and testing was reviewed by the FDA. Results demonstrated that the Apnea-Hypopnea Index (AHI) was significantly reduced while using Bongo Rx compared to the patients’ baseline diagnostic test. There were no serious adverse events.

Will I need a prescription for Bongo Rx?
Yes, in the United States, all devices that treat obstructive sleep apnea (OSA) require a prescription. Ask your doctor to list “Bongo Rx” on the prescription itself. If you have additional questions about your prescription or would like a prescription form please contact us and we'll be happy to assist.

Who might benefit from using Bongo Rx?
Bongo Rx was designed for people with mild to moderate obstructive sleep apnea (OSA). For example those who are:

• Newly diagnosed without significant comorbidities to use as a first line sleep apnea treatment option.
• Unable to get a CPAP, do not qualify for CPAP, or cannot afford CPAP because of high deductibles, or high co-payments.
• No longer using their CPAP and looking for a user-friendly alternative.
• Using their CPAP, but need a device to use while traveling, camping, or any time electricity may not be available.

Is Bongo Rx reusable?
Yes, Bongo Rx is reusable and may be cleaned simply with soap and water per the instructions for up to 90 days.

Is Bongo Rx reimbursed under insurance or is it FSA/HSA eligible?
Bongo Rx, like many CPAP alternative sleep apnea therapy devices, is not a covered item under most medical insurance plans. You should be able to utilize health savings plans, such as FSA (Flexible Spending Account) and HSA (Health Savings Account), for the Bongo Rx since it is a prescription device for the treatment of sleep apnea. We recommend that you check with your FSA/HSA and insurance provider if you have questions about coverage.

Any tips for success with Bongo Rx?
Bongo Rx is intuitive and easy to use since it does not require assembly or disassembly. It can even be put on in the dark. With any new treatment, it is important to acknowledge that there may be an acclimation period. It may take you several days to get used to your Bongo Rx sleep apnea therapy device, especially if you have never tried other options like CPAP. Here are a few tips to help you acclimate to Bongo Rx:

• EXPERIMENT WITH SIZING: Try all sizes. Start with the smallest size and work your way up to the one you prefer. Make sure the nasal seals are not too deep and that they seal comfortably.
• PRACTICE EXHALING: You will feel a small resistance when exhaling letting you know the device is properly working. Also, it is okay to exhale through your mouth occasionally when wearing the device until you fall asleep as people generally switch to nasal breathing once asleep.
• RELAX & START SLOW: You may want to first wear the device while you are reading or watching TV to get used to the feel. Minimize activity while wearing the device and just try to relax.
• EXPERIMENT WITH & WITHOUT HEADGEAR: Try the device first without the headgear. Second, try the headgear with the different sizes until you find the right combination for you.
• REPEAT: If you wake up feeling uncomfortable during the night, take the device off and try again tomorrow.
• COMMIT: Some people adjust to Bongo Rx therapy right away; others need more time. Give it the time you need considering the positive benefits of treating your sleep apnea.