FDA approves ‘tongue strengthening’ device for certain patients with sleep apnea


FDA approves 'tongue strengthening' device for certain patients with sleep apnea

(HealthDay) – The United States Food and Drug Administration on Friday approved the marketing of a new “tongue strengthening” device to reduce snoring in patients with mild obstructive sleep apnea.

Unlike devices used during sleep, this prescription device is used while awake and is designed to stimulate and strengthen the tongue so that it does not collapse backwards and obstruct the airways during sleep. sleep.

“Obstructive sleep apnea not only impacts the quality of sleep, but can also have other serious health effects if left untreated,” said Dr. Malvina Eydelman, director of the office of ophthalmic, anesthetic, respiratory, ENT and dental devices at the FDA’s Center for Devices and Radiologic Health, said in a press release from the agency.

The authorization of the new device “offers a new option for the thousands of people who suffer from snoring or mild sleep apnea,” Eydelman added.

An expert who treats sleep apnea, however, doubted the device would have a major effect.

“The device is only useful in patients with mild obstructive sleep apnea, and the applicability of the device remains to be seen, as the numbers suggest only minor improvements in patients with already existing disease. benign, ”said Dr Thomas Kilkenny. He directs sleep medicine at Staten Island University Hospital in New York.

The device, called eXciteOSA, is a tongue muscle stimulator that gives neuromuscular stimulation to the tongue and is intended for adult patients. According to the FDA, the device works by giving electrical muscle stimulation through a mouthpiece that sits around the tongue.

The mouthpiece has four electrodes, two located above the tongue and two located below the tongue. Muscle stimulation is given in a series of electrical pulses with periods of rest in between. It is used for 20 minutes once a day for six weeks, and once a week thereafter.

The FDA tested the safety and effectiveness of eXciteOSA in 115 patients who snore, including 48 with snoring and mild sleep apnea.

Overall, the time spent snoring was reduced by more than 20% in 87 out of 115 patients, the agency said. And, in patients with mild obstructive sleep apnea in particular, snoring was reduced by 48% in 41 of 48 patients.

The most common unwanted side effects were excessive salivation, discomfort in the tongue or teeth, tingling of the tongue, tooth filling sensitivity, metallic taste, gagging and a tight jaw, the agency said. .

Dr. Steven Feinsilver heads the Center for Sleep Medicine at Lenox Hill Hospital in New York City. He agreed with Eydelman that the new device might have limited use, although new sleep apnea therapies are badly needed.

“Sleep apnea is about as common as diabetes – around 4% of the adult population,” Feinsilver said.

“Currently, the most effective form of treatment is to sleep with a [mask] device that pressurizes the back of the throat to keep it open (CPAP), but this is not always well tolerated, ”he noted.

“We know that muscles in the upper respiratory tract like the tongue actively work to keep the airways open during sleep, and it’s likely that these muscles could be trained or strengthened,” Feinsilver reasoned. “This device appears to be a simple way to increase muscle tone in the tongue.”

Yet eXciteOSA “has obviously only been used in patients with very mild sleep apnea. It is an interesting avenue for a new form of treatment, but I would need to see its effect on those with suffer from significant sleep apnea rather than just improve snoring, ”Feinsilver says.

Kilkenny agreed, noting that while the device has been shown to reduce some snoring, it may not translate to real improvement in sleep apnea. “There is no comment regarding the clinical improvements in the condition of the patients,” he said.

According to the FDA, patients must undergo a dental exam before using the device. The eXciteOSA device is not recommended for patients with pacemakers or implanted electrodes; those with temporary or permanent implants, braces, prostheses / restorations / intraoral metal appliances or dental jewelry in the mouth; women who are or may be pregnant; or those who suffer from ulcers in or around the mouth.

The eXciteOSA device is also not intended for patients with sleep apnea measured with an apnea-hypopnea index of 15 and above. Mild sleep apnea is a score over five but less than 15.

The device is manufactured by Signifier Medical Technologies, LLC.

Untreated sleep apnea is associated with influenza hospitalization

More information:
To learn more about sleep apnea, visit Sleep foundation.

Copyright © 2020 HealthDay. All rights reserved.

Quote: FDA Approves “ Tongue Strengthening ” Device for Certain Patients With Sleep Apnea (February 8, 2021) Retrieved February 8, 2021 from https://medicalxpress.com/news/2021-02-fda -tongue-device-apnea-patients.html

This document is subject to copyright. Apart from any fair use for study or private research, no part may be reproduced without written permission. The content is provided for information only.


About health

Check Also

10 Easy Ways to a Healthy Diet for children’s

Creating a nutritionally wholesome home is one of the maximum important steps you can take …


  1. Has anybody ever shopped at Edmond Vapes Vapor Store in 5 NM Road 344?

  2. Has anyone shopped at All Day Vaper Vapor Store located in 9700 Medlock Bridge Rd?

  3. Has anyone ever tried Salty Five eJuice E-Juice?

  4. what medical conditions are allowed for cbd oil

  5. Is anyone here in a position to recommend Male Love Dolls? Cheers xox

  6. who produces the cbd drug emporium

  7. Can anyone able to recommend quality Ear Nose And Throat Department B2B Leads? Thank you 🙂

  8. some genuinely marvellous work on behalf of the owner of this website , utterly great content.

  9. Does anyone know if I am able to purchase Just Delta 8 Cartridges (justdeltastore.com) from Valley Vapors, 15 N Broadway, Wind Gap, PA, 18091?

  10. Hello everyone , can anyone suggest where I can purchase Ecopets Bacon CBD Tincture For Pets 1800mg By Eco Sciences?

  11. how much is the cbd industry worth now?

  12. Does anybody know if I am able to buy JUSTKRATOM Green Maeng DA Kratom Powder (justkratomstore.com) at Sublett Vapes, 4810 W. Sublett Rd, Arlington, TX, 76017?

  13. will hemp protein make you test positive

  14. Has anyone shopped at Vapor4Life Vape Shop in 408 West Main St?

  15. Has anyone ever been to Hwy 9 Vapor Vape Store located in 3108 S Parker Rd, Ste D2?

  16. Has anyone ever been to No-Match Bury Vapor Store located in 8457 Seneca Turnpike?

  17. I was wondering if anyone knows what happened to Dime Piece LA celebrity streetwear brand? I seem to be unable to check out on Dimepiecela site. I have read in The Sun that the brand was bought out by a UK hedge fund in excess of $50 million. I have just bought the Dimepiece Ball is Life Pom Pom Knit Cap from Amazon and absolutely love it xox

  18. Hello everybody ! can anyone advise where I can buy CBDfx CBD Edible Broad Spectrum Turmeric Spirulina Gummies 200mg 1500mg?

  19. By way of introduction, I am Mark Schaefer, and I represent Nutritional Products International. We serve both international and domestic manufacturers who are seeking to gain more distribution within the United States. Your brand recently caught my attention, so I am contacting you today to discuss the possibility of expanding your national distribution reach.We provide expertise in all areas of distribution, and our offerings include the following: Turnkey/One-stop solution, Active accounts with major U.S. distributors and retailers, Our executive team held executive positions with Walmart and Amazon, Our proven sales force has public relations, branding, and marketing all under one roof, We focus on both new and existing product lines, Warehousing and logistics. Our company has a proven history of initiating accounts and placing orders with major distribution outlets. Our history allows us to have intimate and unique relationships with key buyers across the United States, thus giving your brand a fast track to market in a professional manner. Please contact me directly so that we can discuss your brand further. Kind Regards, Mark Schaefer, marks@nutricompany.com, VP of Business Development, Nutritional Products International, 101 Plaza Real S, Ste #224, Boca Raton, FL 33432, Office: 561-544-0719

  20. Is anyone here in a position to recommend Christmas Lingerie? Cheers xox

Leave a Reply

Your email address will not be published. Required fields are marked *

Open chat
Can we help you?