FDA Authorizes Novel eXciteOSA Device to Reduce Snoring, Mild Sleep Apnea

Malvina Eydelman, MD

The FDA has authorized marketing of a new prescription for Signifier Medical Technologies’ eXciteOSA device intended to reduce snoring and mild obstructive sleep apnea (OSA) in adult patients who are aged 18 years or older, according to a recent announcement.¹

Contrary to other traditional devices that treat OSA while a patient is sleeping, this is the first 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.

The eXciteOSA device is designed by delivering electrical muscle stimulation through a mouthpiece located around the tongue. A total of 4 electrodes, 2 located above the tongue and 2 below, provide the stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. Patients utilize the device once daily for 20 minutes during a wakeful state, for a period of 6 weeks, and once a week thereafter.

"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, Center for Devices and Radiological Health, FDA, said in a statement.

READ MORE: Vivos Submits Application for mmRNA Oral Appliance to Treat OSA

The basis of the agency’s decision comes from a recently conducted study by the FDA, which assessed the safety and effectiveness of the device in 115 patients with snoring, as well as 48 patients with snoring and mild OSA. At the conclusion of the study, the percent of time spent snoring at levels louder than 40 dB was reduced by more than 20% in 87 of the 115 patients.

Among the subset population of patients with snoring and mild OSA, 41 of 48 individuals had their average Apnea-Hypopnea Index (AHI) reduced by 48%, from 10.21 to 5.27. All patients used discontinued use of the device for 2 weeks before they were reassessed.

Researchers noted that excessive salivation, tongue or tooth discomfort, tongue tingling, dental filing sensitivity, metallic taste, gaggling and tight jaw, were among the most commonly observed adverse events (AEs).

In addition to the mouthpiece, the eXciteOSA device also comes with a rechargeable control unit, which attaches to the mouthpiece via a USB connection and is driven by the eXciteOSA app for maximum freedom during use. The app then allows patients to follow and control their therapy, as well as track changes in snoring.²

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 with ulcerations in or around the mouth. Patients who are suspected of having OSA with an AHI of 15 and higher are not applicable for the device.

For more information on eXciteOSA, click here.

REFERENCES

1. FDA Authorizes marketing of novel device to reduce snoring and mild obstructive sleep apnea in patients 18 years and older. News release. February 5, 2021. Accessed February 9, 2021. https://www.prnewswire.com/news-releases/fda-authorizes-marketing-of-novel-device-to-reduce-snoring-and-mild-obstructive-sleep-apnea-in-patients-18-years-and-older-301223205.html

2. Sleep better with eXciteOSA. eXciteOSA. https://exciteosa.com/how-exciteosa-can-help/. Accessed February 9, 2021.