FDA Accepted Sleep Apnea Appliances
The Food and Drug Administration, or FDA, is charged with protecting consumers. They regulate medical devices such as sleep apnea appliances. Since 2010, the FDA has granted premarket notification to more than 65 different sleep apnea appliances. In order to be accepted, they must be found to be safe, effective, and perform as promised. These oral appliances are not available over the counter but can only be acquired with a prescription.
Many different models are currently available, and all of them are FDA-accepted for treating obstructive sleep apnea. They are only appropriate for treating mild to moderate obstructive sleep apnea and should only be used by patients over the age of 18. Although appliances are available online, they still must be prescribed by a medical professional. Purchasing an appliance online also exposes you to the risks of a poorly fit appliance, which may not work as effectively as a customized appliance and may be uncomfortable to wear.
If you have obstructive sleep apnea and are interested in an alternative to traditional CPAP therapy, an FDA-approved sleep apnea appliance may be right for you. We offer evaluations and help patients learn more about their treatment options. Patients who are candidates for oral appliance therapy will be prescribed a specific model that best meets their needs, and the appliance will be custom fit for the greatest comfort and effectiveness possible. Give us a call today to learn more about sleep apnea appliance therapy or to schedule your appointment with our Los Angeles sleep apnea expert.