Frequently Asked Questions

General

Snoring is caused by vibration of the structures of the throat during sleep.  When you sleep, the muscles of the upper airway and tongue relax and partially collapse. The narrowest parts of the throat can then create turbulence in the air flowing through your upper airway as you exhale – creating the snoring sound.

You’re more likely to snore if you:

  • Are overweight
  • Smoke
  • Drink too much alcohol
  • Sleep on your back

In addition to the research showing that snoring affects the sleep quality of the snorer and the bed partner, it also may be indicative of a more serious condition called obstructive sleep apnea (OSA). OSA is a serious health condition associated with other health problems, such as high blood pressure and increased risks of heart attack, stroke, or death. Primary snoring itself, even without progressing to OSA, has been associated with increased health risk in addition to the impact on quality-of-life.

Sleep apnea is often associated with snoring, daytime sleepiness, and fatigue. It is also common for loved ones of sleep apnea patients to notice that their partner momentarily holds their breath or stops breathing during the night. Sleep apnea is a serious health condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death.

If you have these symptoms or are concerned you may have the condition, please see your doctor. With a sleep test, your doctor can diagnose your condition and recommend a course of action.

eXciteOSA improves the muscle function in the tongue through stimulation therapy. Improvement of muscle function prevents the tongue from collapsing backwards and trains the upper airway to remain open during sleep, thereby improving sleep quality.

The mouthpiece is made from flexible silicone which should sit around your tongue comfortably. If you experience any discomfort, reposition the mouthpiece into a more comfortable position. Like any object when placed in the mouth, you might experience increased saliva in your mouth while doing the therapy, or in rare cases a gag reflex.

 

If you experience excessive salivation during your therapy, you can pause the therapy, address the saliva, and then continue with the therapy.

Multiple clinical studies have tested the effectiveness of eXciteOSA therapy and have observed statistically significant reductions in both mild obstructive sleep apnea and snoring measurements. In a group of 65 mild OSA patients, 79% noticed a notable reduction in three different mild OSA measurements (AHI, ODI, and ESS Score). In a group of 115 snoring patients, 90% demonstrated an objective snoring reduction of 46%.

We have additional ongoing clinical trials in the US that will be completed in the near future.

eXciteOSA is not currently covered by insurance, but it is FSA and HSA compatible.

Your eXciteOSA device should be worn for twenty minutes a day, one time each day, for six weeks, and only twice per week thereafter.

Some patients experience a slight accumulation of saliva, but this sensation will likely go away after a few therapy sessions.

You will not be eligible for eXciteOSA therapy if you…

  • are pregnant or may become pregnant.
  • have a pacemaker, or an implanted electrode.
  • 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 ≥ 15 as determined by evaluation by a Sleep Health Professional with a sleep study.

Our clinical trials did not include patients with a BMI over 35, so it is not known if the eXciteOSA® therapy will be effective in patients with a BMI above 35.

eXciteOSA Patients

I’ve purchased my eXciteOSA device.
What’s next?

  • Control unit
  • Mouthpiece
  • USB charging cable
  • Quick Start Guide

The mouthpiece is connected to the control unit through a USB connector. The mouthpiece is placed in your mouth, positioning it around your tongue. Two tabs of the mouthpiece should sit comfortably above and two sit below – like a glove. There’s no need to bite down on the mouthpiece or do anything to hold it in position. The mouthpiece is designed so when you gently close your mouth, it will naturally sit around your tongue and won’t move during the therapy.

The device can be used at any point during the day. Some users prefer to use the device right before sleep because this helps them be more consistent. We recommend using the device during a time that will conveniently allow you to build a steady habit out of your therapy

The control unit is charged through the USB port using a USB charging cable. The blue light of the control unit will blink during charging and become continuous when fully charged.

With one full charge, you should be able to finish six 20-minute therapy sessions. The eXciteOSA app won’t allow you to start a new therapy unless there is adequate charge within the control unit to complete a full session.

When the therapy is running, the timer on the app will tick down. Additionally, the blue LED ‘S’ logo on the control unit will blink once every 5 seconds. Most importantly, you should feel gentle contractions of your tongue muscle.

Once you begin therapy, you’ll have the ability to manually change your therapy levels during every session, every day. This is what makes this experience so unique to you. To change the level, simply slide your therapy level setting at the bottom of your screen on the eXciteOSA mobile app during your session.

While therapy level can be controlled manually, there is a cutoff in place to ensure that the device does not exceed 70 mA.

Each 20 session is broken up into four 5-minute intervals. Each interval will prompt the device to give off a different frequency. The frequencies will occur, in order, up to 20 Hz. Each 5-minute phase is meant to train your tongue in a different way.

It is recommended to only do one session each day. Just like your body needs to recover after a workout, your tongue also needs to rest and recharge.

Most users notice improvements in as soon as 4 weeks. Efficacy is dependent upon adherence to the recommended therapy program of 20-minute sessions, completed 1 time each day, for 6 weeks.

Therapy sessions are 20 minutes long, are completed 1 time each day, for 6 weeks. A minimum of two 20-minute sessions are required each week thereafter. Failure to complete the therapy sessions following the 6-week period may result in a return of your mild obstructive sleep apnea and/or snoring symptoms. Consistency is key!

We are confident that our mouthpiece will function safely and as intended for 90 days. Beyond this period, the safety and functional performance of the mouthpiece is not guaranteed and places our patients at undue risk.

Mouthpiece

The mouthpiece should be cleaned before and after each use. Use tap water to clean the mouthpiece. Dry with a clean towel and store in a dry place. DO NOT clean with alcohol-based cleaning solutions.

Control Unit

Wipe the control unit surface with a damp cloth or antiseptic wipe once a week.
DO NOT immerse the control unit in water or cleaning solutions. Always store the control unit in a dry place.

You can purchase a replacement mouthpiece with the physician or DME that provided you with your eXciteOSA. If you cannot arrange this though your original provider, we will ensure that you are able to purchase a mouthpiece from Signifier Medical Technologies directly.

We are continuously improving the functionality of the app, and you can find firmware details on the support page.

Go to the app download page to find the latest version of the app.

Please note that the Android BT upload is much slower (15-17 minutes) compared to the iOS (4-5 minutes). This is operating software specific.

eXciteOSA provides a warranty to the original purchaser confirming the product will be free from defects in the material, components and workmanship for a period of 3 months for the mouthpiece from the date of purchase, and 1 year for the control unit.

For valid warranty claims, the user must return proof of purchase to support@signifiermedical.com.

The warranty does not include any misuse or abuse such as dropping the device, immersing the control unit in water or other liquids, or tampering with the device. Any evidence of tampering will void the warranty. This warranty does not apply to “wear and tear” that occurs with normal usage

If you are not completely satisfied with the eXciteOSA therapy, you may return it to us for a full refund. All Satisfaction Guarantee returns must be postmarked within 30 days of activating the device. All returned items must be in original packaging.

If your device is defective or damaged, please contact our customer support team at support@signifiermedical.com.

Troubleshooting

If you’re having trouble pairing to the device during your first use…

    • make sure that your control unit is totally charged.
    • make sure that both your bluetooth and GPS functionality are turned on in your smartphone’s settings.

Try not to walk too far away from your phone during therapy. Aim to stay within 10 meters.

If there was a high accumulation of saliva during your therapy session, disconnect the mouthpiece from the control unit and dry off the connector. You may need to let the device sit for a few hours. Make sure the connector has dried thoroughly before starting another therapy session.

If you attempted to complete a therapy session while you were within 12 inches of any antenna cables or electrical equipment, retry your session while keeping distance from this equipment.

If you see a solid amber light when the device is connected to a charger, this amber light simply means that the device is charging. Once the light is blue, the device is ready for use.

If there is a solid amber light when the mouthpiece and control unit are connected, try connecting the mouthpiece and control unit in the opposite orientation.

If you’ve experienced a high accumulation of saliva during a prior therapy session, you can try to disconnect the mouthpiece and control unit for a few hours until the connector has dried thoroughly.

If the issue remains, you may need a replacement device. Please contact us at support@signifiermedical.com for further instruction.

This means that your device needs charging. Please leave it connected to a charger for 4+ hours. Once you see a blue light, the device is ready for use.

Gradually increase your therapy levels until you feel stimulation again. Over the duration of your therapy program, your tolerance levels will increase, which means that you will likely find yourself increasing the therapy level from week to week.

If you cannot feel any stimulation coming from the back electrodes, try to reposition the mouthpiece so it comfortably encompasses your tongue, like a glove. This should allow the back electrodes to make contact with your tongue.

If you still cannot feel any stimulation from one or more of the electrodes, check for any visible damage to the mouthpiece. You may need a replacement. Please contact support@signifiermedical.com for further instruction.

For additional information, visit our website at eXciteOSA.com, call us at +1 844 MildOSA, or contact us via email at info@signfiermedical.com.

eXciteOSA® is a registered trademark of Signifier Medical Technologies. ©2021 Signifier Medical Technologies. All rights reserved. EX0025 4/21