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# De Novo Granted for Snoring/Sleep Apnea Device
- URL: https://www.fdaweb.com/de-novo-granted-for-snoring-sleep-apnea-device/
- Published: 2021-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:45:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148606

FDA has granted a Signifier Medical Technologies de novo request to permit the marketing of a new prescription-only device, eXciteOSA, 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,” an [FDA release](https://content.govdelivery.com/accounts/USFDA/bulletins/2bfc1c7?ref=fdaweb.com) says.  

eXciteOSA is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue to reduce snoring and mild sleep apnea for patients who are 18 years or older. It 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,” FDA says. “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 six‐weeks, and once a week thereafter.”

The de novo authorization was made based on data from 115 patients with snoring, including 48 patients with snoring and mild sleep apnea, the agency says. “All patients used the device for 20 minutes, once a day for six weeks, then discontinued use for two weeks before they were reassessed,” it says. “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 \[Apnea-Hypopnea Index (AHI) measure\] 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.”