Frequently Asked Questions

+ How much weight can people expect to lose with the SmartByte System?

In FDA clinical studies, people who used SmartByte over 4 months lost:[1]

Per Protocol Population: Used as directed – At least 1/3 of meals
4.4% of their total body weight
38.1% of their excess body weight
8.8 pounds (200 pound person)

Intent to Treat Population: Not used as directed (60% of population) plus those that did use as directed
1.7% of their total body weight
14.6% of their excess body weight
3.4 pounds (200 pound person)

In FDA Clinical Studies, people who used SmartByte over 4 months lost the following average percent body weight based on their percent usage:[1]

chart

+ How does the SmartByte Device feel?

The SmartByte Device is custom-molded to fit the roof of the mouth and only used during eating. The SmartByte Device feels comfortable and causes people to be more mindful during eating. Many people feel that their initial experience with the SmartByte Device is similar to contact lenses. They’ll notice it on the first day or two but quickly get used to it.

+ Are there any foods that can’t be eaten with the SmartByte Device?

There are no food limitations, however some foods will take longer to eat than others. As a general rule, harder and more dense foods will take longer to eat.

+ Can people choke on the SmartByte Device?

The SmartByte Device is designed to be larger than the throat to prevent choking.

+ Is there a risk of gagging with the SmartByte Device?

If people have a sensitive gag reflex then they may not be candidates for the SmartByte System. When placed in position on the roof of the mouth, the SmartByte Device is designed to remain in a fixed position.

+ Can people see the SmartByte Device while worn?

The SmartByte Device is designed to be discrete and can’t be seen by other people unless it’s shown to them.

+ Can people talk with the SmartByte Device in their mouth?

People can talk with the SmartByte Device, however the way that they speak will sound slightly different than normal at first. Most people quickly get used to speaking with the SmartByte Device. Since people control placement of the SmartByte Device, they can decide when to use it.

+ How long can the SmartByte Device be worn?

The SmartByte Device is designed for to be used for no more than an hour at a time, and not more than 2.5 hours a day. The material that holds the SmartByte Device to your upper teeth softens while in the mouth so prolonged use may loosen its fit.

+ How is the SmartByte Device cleaned?

The SmartByte Device should be cleaned with a soft-bristled toothbrush and toothpaste then rinsed with cold water after each use.

+ How is the SmartByte Device carried?

The SmartByte Device comes with a compact and easy-to-use carrying case that will protect it between uses.

+ How long does the SmartByte Device last?

The SmartByte Device is designed to last 1.2 years.

+ Are there any side effects with using the SmartByte Device?

The most common complications, which occur in less than 2% of people, are soreness in the mouth, gagging upon insertion of the device or momentary gagging of food during device use.


[1] FDA, Department of Health & Human Services, SmartByte Device, Regulation Number: 21 CFR§ 876.5981, 2016.