Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
The Food and Drug Administration (FDA) has authorized marketing of eXciteOSA® (Signifier Medical Technologies), a new prescription only device indicated to treat mild obstructive sleep apnea (OSA) and reduce snoring in patients 18 years of age and older.
The eXciteOSA device is used while the individual is awake and provides electrical muscle stimulation through a mouthpiece that sits around the tongue. It is used for 20 minutes once a day, for a period of 6‐weeks, and once a week thereafter. The device is not intended for patients who have or are suspected of having OSA with an Apnea-Hypopnea Index (AHI) of 15 or higher.
The safety and effectiveness of the device was assessed in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea. Results showed a greater than 20% mean reduction in snoring time (at levels louder than 40dB) in 87 patients. Among patients with mild OSA (n=65), 79% responded to therapy with a mean reduction of 52% in AHI, a 58% reduction in oxygen desaturation index, and a 3.9 point reduction in Epworth Sleepiness Scale score. The most common adverse events observed were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw.
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 Company has developed an app for patients and clinicians to use alongside the eXciteOSA device. The app allows patients to control the device through Bluetooth wireless technology, and includes digital connectivity between patient, bed partner and provider to enable virtual setup as well as remote monitoring. The app will be available in the App Store and Google Play Store.
For more information visit exciteosa.com.
References
1. FDA authorizes marketing of novel device to reduce snoring and mild obstructive sleep apnea in patients 18 Years and older. [press release]. Silver Spring, MD: Food and Drug Administration; February 5, 2021.
2. Signifier Medical ushers in new era of treatment for sleep apnea and snoring with FDA approval of eXciteOSA device. [press release]. Boston, MA and London, UK: Signifier Medical Technologies; February 8, 2021.
