The FDA (Food and Drug Administration) is in charge of protecting consumers, and part of their responsibility lies in regulating medical devices such as sleep apnea appliances. Since 2010, FDA has granted premarket notification to over 65 different sleep apnea appliances. The appliances must be found to be safe, effective, and perform as promised in order to be prescribed to patients.
There are numerous different models available, and all of them have been FDA-approved for treating obstructive sleep apnea. They should only be used for patients over the age of 18, and they are only recommended for treating mild to moderate cases of sleep apnea. You should avoid purchasing a sleep apnea appliance online since it may not provide the same quality fit you would get with a customized appliance.
If you are interested in a sleep apnea treatment that does not involve a CPAP machine, an FDA-approved sleep apnea appliance may be right for you. Our doctors can evaluate your condition to see what your options are. If you qualify for an oral device, you will be given a model that can best treat your needs. If you feel you may be at risk of sleep apnea, schedule a consultation with our sleep apnea expert today.