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Dear Readers, Welcome to the latest issue of The Magazine
Now, the U.S. Food and Drug Administration approved marketing of a new prescription only device intended to reduce snoring and moderate obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time helps prevent the tongue from collapsing backward and blocking the airway during sleep.
Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea.”
Malvina Eydelman, MD., Director, Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, FDA’s Center for Devices and Radiological Health
Obstructive sleep apnea (OSA) is a prevalent sleep-disordered breathing with possible serious long-term effects. It can happen when the upper airway becomes blocked repeatedly during sleep, reducing or completely stopping airflow. Untreated OSA may lead to serious complications such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders. OSA is categorized by the amount of apneas (pauses in breathing) and the number of hypopneas (intervals of shallow breathing) that occur, normally, each hour. This amount, called the Apnea-Hypopnea Index (AHI) measures the severity of OSA. Mild OSA is defined as an AHI score of more than five but less than 15. The device, the eXciteOSA, is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue to be able to reduce snoring and mild sleep apnea for individuals who are 18 years or older.
The eXciteOSA mouthpiece has four electrodes, two located above the tongue and two situated beneath the tongue. The device provides electrical muscle stimulation action in sessions which consist of a series of electrical pulses with rest periods in between.
The FDA evaluated the safety and efficacy of the eXciteOSA apparatus in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea. All patients used the device for 20 minutes, once a day for 6 weeks, then discontinued use for two weeks before they were reassessed. Overall, the percent of time spent alcoholism at levels louder than 40dB was decreased by more than 20% in 87 from the 115 patients.
Patients should get a thorough dental examination prior to use of the apparatus. The eXciteOSA device is contraindicated for patients with pacemakers or implanted pacing leads (electrodes); patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations/appliances or dental jewelry at the mouth; patients that are pregnant or could be pregnant; or patients suffering from ulcerations in or around the mouth.
The FDA reviewed the apparatus through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk apparatus of a new type. In addition to this authorization, the FDA is establishing special controls for devices of this kind, including requirements related to labeling and performance testing. When met, the specific controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of the type.
The FDA granted the marketing authorization to Signifier Medical Technologies, LLC.
U.S. Food and Drug Administration
