Frequently Asked Questions
+ How much weight can people expect to lose with the SmartByte System?
In clinical studies, people using SmartByte lost 38% excess body weight in only 4 months.1
SmartByte has been studied in 5 clinical trials with over 300 people. Based on the safety and effectiveness results from 2 of these clinical trials, the FDA cleared SmartByte for sale in September 2016. Results from the 2 additional clinical trials have been published in distinguished medical journals.
In clinical studies, people using SmartByte as directed (at least 1/3 of meals) lost 38% excess body weight (4.4% total body weight, 8.8 lbs. for a 200 lb. person) in 4 months. People who did not use SmartByte as directed lost an average 14.6% excess body weight in 4 months.
In another published clinical trial, people ate 533 fewer calories per day by using SmartByte.2 It takes 3,500 calories to burn 1 pound of fat. It’s well known in medical literature that losing weight has a positive impact on improving health.3
SmartByte is for weight management in overweight/obese individuals with a body mass index (BMI) of 27-35 kg/m2 and with behavioral modification instruction, SmartByte is not for people with eating disorders or who are pregnant. Individual results may vary.
1 FDA, Department of Health & Human Services, SmartByte Device, Regulation Number: 21 CFR§ 876.5981, 2016.
2 Walden H., et al., A new dental approach to reducing food intake. Obesity Research 2004; 12: 1773-1780.
3 Moore, L., Weight loss in overweight adults and the long term risk of hypertension: The Framingham Study. Arch Intern Med. 2005; June 13; 165(11): 1298-303.
+ 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.
 FDA, Department of Health & Human Services, SmartByte Device, Regulation Number: 21 CFR§ 876.5981, 2016.