[News] FDA Authorizes Novel (Oral) Device

[Gideon]

FYI
FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older

https://www.fda.gov/news-events/press-an...atients-18

For Immediate Release:February 05, 2021
Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild 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 can help prevent the tongue from collapsing backwards and obstructing 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,” said Malvina Eydelman, MD., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.
Obstructive sleep apnea (OSA) is a prevalent sleep-disordered breathing with potential serious long-term effects. It can occur when the upper airway becomes blocked repeatedly during sleep, reducing or completely stopping airflow. Untreated OSA can lead to serious complications such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders. OSA is categorized by the number of apneas (pauses in breathing) plus the number of hypopneas (periods of shallow breathing) that occur, on average, each hour. This number, 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 in order to reduce snoring and mild sleep apnea for patients who are 18 years or older.
The eXciteOSA device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The eXciteOSA mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state, for a period of 6‐weeks, and once a week thereafter.
The FDA assessed the safety and effectiveness of the eXciteOSA device 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 2 weeks before they were reassessed. Overall, the percent of time spent snoring at levels louder than 40dB was reduced by more than 20% in 87 out of the 115 patients. In a 48-patient subset with snoring and mild OSA, the average AHI reduced by 48%, from 10.21 to 5.27, in 41 out of 48 patients. The most common adverse events observed were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw.
Patients should receive a comprehensive dental examination prior to use of the device. 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 in the mouth; patients who are pregnant or may be pregnant; or patients suffering from ulcerations in or around the mouth. The eXciteOSA device is not intended for patients who have or are suspected of having OSA with an AHI of 15 and higher.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. This means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.
The FDA granted the marketing authorization to Signifier Medical Technologies, LLC.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.