FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older
SILBERFEDER, Md., February 5, 2021 / PRNewswire / – Today the US Food and Drug Administration cleared the commercialization of a new prescription device for reducing snoring and mild obstructive sleep apnea. Unlike devices that are used when the patient is asleep, this is the first device to be used while awake and designed to improve tongue muscle function. Over time, this can help keep the tongue from collapsing backwards and blocking the airway during sleep.
“Obstructive sleep apnea not only affects the quality of sleep, it can also have other serious health effects if left untreated. Today’s approval provides a new option for thousands of people with snoring or mild sleep apnea,” he said Malvina Eydelman, MD., Director of the Office of Eye, Anesthesia, Respiratory, ENT, and Dental Devices at the FDA Center for Devices and Radiological Health.
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder with potentially serious long-term effects. This can occur when the upper airway becomes repeatedly blocked during sleep and airflow is decreased or stopped completely. Untreated OSA can lead to serious complications such as heart attacks, glaucoma, diabetes, cancer, and cognitive and behavioral disorders. OSA is categorized according to the number of apneas (pauses in breathing) plus the number of hypopneas (periods of shallow breathing) that occur on average per hour. This number, called the Apnea-Hypopnea Index (AHI), measures the severity of OSA. Mild OSA is defined as an AHI greater than five but less than 15. The device, eXciteOSA, is a removable tongue muscle stimulator that provides neuromuscular stimulation to the tongue to reduce snoring and mild sleep apnea in patients 18 years of age or older.
The eXciteOSA device delivers electrical muscle stimulation through a mouthpiece that sits around the tongue. The eXciteOSA mouthpiece has four electrodes, two above the tongue and two under the tongue. The device provides electrical muscle stimulation in sessions that consist of a series of electrical impulses with periods of rest in between. It is used once a day for 20 minutes while awake, for 6 weeks, and then once a week thereafter.
The FDA evaluated 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, and then stopped using it for 2 weeks before being re-examined. Overall, in 87 of the 115 patients, the percentage of time spent snoring at volumes greater than 40 dB was reduced by more than 20%. In a subset of 48 patients with snoring and mild OSA, the mean AHI decreased by 48% from 10.21 to 5.27 in 41 of 48 patients. The most common adverse events observed were excessive salivation, tongue or tooth discomfort, tongue tingling, tenderness to filling, metallic taste, gagging, and firm jaw.
Patients should have a full dental exam prior to using the device. The eXciteOSA device is contraindicated for patients with cardiac pacemakers or implanted stimulation leads (electrodes). Patients with temporary or permanent implants, braces, intraoral metal prostheses / restorations / devices or dental jewelry in their mouth; pregnant or possibly pregnant patients; or patients who have ulcers 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 or greater.
The FDA reviewed the device via the De Novo Premarket Review Pathway, a regulatory pathway for a new type of low to medium risk device. Along with this approval, the FDA establishes specific controls for devices of this type, including requirements for labeling and performance testing. This means that subsequent devices of the same type with the same purpose can go through the FDA’s 510 (k) pre-market notification process, which allows devices to be approved for placing on the market by demonstrating significant equivalence to a rated device. When met, the specific controls, along with the general controls, provide reasonable safety and effectiveness for devices of this type.
The FDA has approved Signifier Medical Technologies, LLC.
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The FDA, an agency of the US Department of Health, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our country’s food supplies, cosmetics, dietary supplements, products that emit electronic radiation, and tobacco products regulation.
SOURCE US Food and Drug Administration