FREQUENTLY ASKED QUESTIONS
+ 1. How does SmartByte work?
SmartByte is a safe, removable, custom made device that is placed comfortably in the upper palate (the roof of the mouth) only while eating. The SmartByte device decreases your oral capacity, so you take smaller bites, which slows food intake and allows onset of your body’s satiety response. Because using the SmartByte device requires more chewing of food, it permits more savoring and tasting of your meal. Triggering your body’s satiety response and enjoying your food makes you feel satisfied on less.
+ 2. What is satiety and how will it help me lose weight?
Satiety is your body’s built-in defense mechanism that guards against overeating. On average, it takes approximately 10-15 minutes for satiety to trigger - for your stomach to tell your brain that it is full. Because modern lifestyles are so rushed, we have become used to gulping our meals (and too many calories) in just a few bites and leaving us with a sense of hunger. Because the SmartByte device slows your rate of eating, it will allow you to feel satisfied from a meal after consuming less of it (and fewer calories).
+ 3. How do I know if I am a candidate for the SmartByte?
The SmartByte device has been studied on individuals with Body Mass Index (BMI) of 27 to 35 in good oral health. A good candidate for SmartByte is an individual who eats too quickly and is motivated to lose weight. People who have dentures or removable dental work (e.g. removable bridge or “partials”) are not candidates for the SmartByte device.
+ 4. How much weight can I expect to lose if I wear the SmartByte device?
In a study conducted at the Pennington Biomedical Research Center in the US, the daily food intake of people using the SmartByte device was reduced by 23% (533 fewer calories in a day) compared to the food intake of people not given the device. In a subsequent scientific study, 173 overweight and mildly obese people were evaluated in a randomized controlled clinical trial. Among those subjects who used the SmartByte device, as directed, the average excess body weight loss (EWL) was 38.1%. This translated into an average of 1-3 pounds (.5 - 1.5 kgs) per week or up to 8% of their total body weight.
+ 5. Is the SmartByte device comfortable?
Each SmartByte device is made using an impression of the upper palate (the roof) of the mouth so your SmartByte device can be custom-made for you alone. The device’s revolutionary design ensure’s maximum comfort for the SmartByte device user.
+ 6. Can I talk when wearing the SmartByte device?
You will be able to speak when wearing the SmartByte devise. Some users may have a slight “lisp” when speaking with the device, especially in the beginning. However, you will find you become used to speaking with it very quickly.
+ 7. Has the safety and efficacy of the SmartByte been evaluated in clinical studies or by FDA?
SmartByte has been proven in four clinical trials published in peer reviewed medical journals. It is one of only six devices for weight control ever approved by FDA. SmartByte is the only one designated Non-significant Risk (NSR). FDA approval is the Gold Standard among medical devices throughout the world. The FDA draft guidance also designates SmartByte as Level One, the safest of all weight loss device categories indicating use starting at Body Mass Index (BMI) 27.