Authors: Tejas Nikumbh MD, Nova Szoka MD, FACS, FASMBS
Signifier Medical Technologies received FDA approval by the DeNovo pathway for the eXciteOSA neuromuscular tongue stimulator in February 2021.
The eXciteOSA is a removable device that delivers neuromuscular stimulation to the tongue to reduce snoring and mild obstructive sleep apnea. Treatment takes twenty minutes a day for a period of six weeks, with weekly sessions thereafter. The electrodes deliver electrical muscle stimulation, similar to transcutaneous electrical nerve stimulation (TENS), to the area around the lower tongue. Strengthening of the tongue muscles prevents closing of the airway, allowing for the free movement of air in and out of the lungs, thus improved breathing.
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 apnea-hypopnea index (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.
This is a novel device with no known predicate
Indications:
- To reduce snoring and mild obstructive sleep apnea [AHI<15]
- For patients 18 years or older
Contraindications:
- Not for use in patients with pacemakers, dental implants, or with OSA with AHI of 15 or higher
