Millions of people have sleep apnea and use devices like continuous positive airway (CPAP) machines, bilevel positive airway pressure (BiPAP) machines, ventilators, or oral appliances to treat their sleep apnea. When you rely on a device to help you breathe, it is highly concerning when it is recalled.
Recall of Philips Respironics Products in 2021
In June 2021, Philips voluntarily recalled many of its Respironics products used to treat sleep apnea. The recall included CPAP machines, BiPAP machines, and ventilators. These devices were recalled because of an issue with the sound-dampening foam inside them.
The Philips recall affected millions of sleep apnea patients, including many who used CPAP machines, BiPAP machines, or ventilators to treat their sleep apnea between 2009 and 2021. While Philips now uses a different sound-dampening foam in their Respironics products, their sleep apnea devices continue to be scrutinized and cause health concerns.
Philips Devices That Were Recalled
Philips recalled several continuous positive airway (CPAP) machines, bilevel positive airway pressure (BiPAP) machines, and ventilators between 2009 and April 26, 2021. Recalled devices include:
A-Series BiPAP A30
A-Series BiPAP A40 (ventilator)
A-Series BiPAP Hybrid A30
A-Series BiPAP V30 Auto (ventilator)
C-Series ASV (ventilator)
C-Series S/T and AVAPS
DreamStation
DreamStation ASV
DreamStation Go
DreamStation ST, AVAPS
Dorma 400
Dorma 500
E30
Garbin Plus, Aeris, LifeVent (ventilator)
OmniLab Advanced+
REMstar SE Auto
SystemOne ASV4
SystemOne (Q-Series)
Trilogy 100 (ventilator)
Trilogy 200 (ventilator)
Additionally, Philips recalled specific models of Trilogy Evo ventilators distributed from April 15, 2021, to May 24, 2021, with specific serial numbers.
Why Were Philips Sleep Apnea Devices Recalled?
The recalled Philips Respironics continuous positive airway (CPAP) machines, bilevel positive airway pressure (BiPAP) machines, and ventilators all had polyester-based polyurethane (PE-PUR) foam inside them. This foam was used to reduce any noise and vibrations the machines generated.
Over time, the sound-dampening foam inside of the machines was likely to break down—mainly when sterilized with an ozone cleaner or exposed to heat and humidity—and release toxic chemicals and tiny particles that could travel through the air tubes of the sleep apnea devices and into sleep apnea patients’ lungs. Users of these devices have reported finding sticky residues or black dust inside their sleep apnea machines’ tubes, filters, and chambers.
Possible Health Risks Sleep Apnea Patients Can Experience from Recalled Devices
The toxic chemical vapors and small particles released by disintegrating PE-PUR foam inside Philips Respironics CPAPs, BiPAPs, and ventilators can harm sleep apnea patients. Documented health effects experienced by sleep apnea patients who used these devices to treat their sleep apnea include:
Asthma
Cancer of the sinuses, throat, esophagus, kidney, and liver
Chronic headaches
Coughing
Dizziness
Nausea and vomiting
Sinus congestion
Skin, nose, and eye irritation
Sore throat
Are There Effective CPAP Alternatives for Sleep Apnea Treatment?
You have options if you no longer feel comfortable using a CPAP, BiPAP, or ventilator from Philips or any other company after the recall.
Oral appliance therapy is an effective sleep apnea treatment for many people who have sleep apnea. An oral appliance is a specially fitted device custom-made by a dentist trained in sleep medicine. An oral appliance’s primary purpose is to keep the airway open during sleep so the normal airflow during breathing isn’t blocked.
Mandibular advancement devices (MADs) and tongue-retaining devices (TRDs) are two commonly used oral appliances for sleep apnea treatment. MADs keep your airway unobstructed by moving your jaw forward, and TRDs keep your tongue from sliding to the back of your mouth and blocking your airway.
A qualified dentist trained in dental sleep medicine will choose the right oral appliance for you based on factors such as mouth size and degree of snoring and create a custom-fitted appliance. Oral appliances are comfortable, relatively nonintrusive, and easily portable, and they can be appealing CPAP alternatives that make it easier for people to be compliant with their sleep apnea treatment.
Benefits of Oral Appliance Therapy Over a CPAP, BiPAP, or Ventilator to Treat Sleep Apnea
Oral appliances offer an effective treatment option for people with sleep apnea who no longer feel comfortable using their CPAP, BiPAP, or ventilator after the Philips recall or have concerns about potential health and safety risks.
Benefits of oral appliances include:
more comfortable and easier to use than a CPAP, BiPAP, or ventilator
doesn’t require electricity to work
easy to take care of and keep clean
improves symptoms of OSA like focus issues and daytime sleepiness
more cost-effective than other treatments
no loud noise
portable and more accessible to take when traveling
reduces or eliminates snoring
Sleep Apnea Specialists in Columbus, Ohio
Sleep apnea is a severe condition, and the sleep apnea specialists at Sleep Better Columbus can help.
Sleep Better Columbus is committed to providing compassionate care for all patients and helping each patient find the best sleep apnea treatment for them.
Sleep Better Columbus’s sleep apnea therapy solution is simple and comfortable, helping those with sleep-disordered breathing sleep better quickly. Their specially designed mouthpieces are an effective and comfortable sleep apnea treatment alternative for those who no longer feel safe or comfortable using a CPAP, BiPAP, or ventilator after the Philips Respironics recall.
Many people wear a CPAP machine at night to treat the interrupted breathing of obstructive sleep apnea, a condition that affects an estimated 22 million Americans. But CPAP machines can be noisy, cumbersome and uncomfortable, and many people stop using the devices altogether, which can have dire long-term consequences.
Mouth guards may be a more comfortable and easy-to-use alternative for many people with obstructive sleep apnea, according to a new report. The study, published in Laryngoscope, looked at 347 people with sleep apnea who were fitted with a mouth guard by an otolaryngologist. Two-thirds of patients reported they were comfortable wearing the devices, and the devices appeared to be effective in helping to relieve the disordered breathing of obstructive sleep apnea.
The lead author of the study, Dr. Guillaume Buiret, head of otolaryngology at Valence Hospital in Valence, France, said that if he had sleep apnea, he would choose an oral appliance first.
“It’s easy to tolerate, effective and it costs a lot less than CPAP,” he said. “Thirty to 40 percent of our patients can’t use CPAP, and these patients almost always find the dental appliance helpful. I would recommend it as a first-line treatment”
Loud snoring may be the most obvious consequence of sleep apnea, but the condition, if left untreated, can lead to a broad range of complications, including high blood pressure, heart disease, liver dysfunction and Type 2 diabetes.
The problem develops when the soft tissue at the back of the throat collapses during sleep, blocking the airway. This leads to breathing cessation for brief periods, gasping for air, difficulty staying asleep, and all the problems of daytime sleepiness, from poor job performance to fatal accidents. Animals can have it too — bulldogs, for example, have a narrow airway and a soft palate that can easily block it. Their sleep apnea is almost identical to the human version.
The severity of the condition varies widely from a very mild problem that may need no treatment at all to severe or even life-threatening disease. Dr. Sara E. Benjamin, a neurologist and sleep specialist at Johns Hopkins, said that spending a night in a sleep laboratory monitored by a technician is the best way to diagnose apnea. A lab study offers the most thorough analysis, and can detect many other sleep problems besides apnea, but there are home test kits that are easy to use and cost-effective. They test breathing effort and oxygen levels, but not the brain waves, muscle tone and leg movements that a lab test records.
How can you know that you need a sleep assessment? “It’s a low standard to get evaluated, either by home testing or in a sleep lab,” Dr. Benjamin said. “If a person feels sleep problems are impacting daily activities, that’s enough to go and get evaluated. If the cause is a breathing problem, you don’t want to ignore it.”
A CPAP — continuous positive airway pressure — machine is usually the first option for treating sleep apnea. The device has a motor that delivers pressurized air through a tube attached to a mask that covers the nose, or both the nose and the mouth. This keeps the airway open. Some machines can automatically change the pressure to compensate for changes in sleep position; others require manual adjustment. Headgear varies, but all have adjustable straps to get the right fit. There are newer models that can deliver heated or humidified air, depending on the patient’s preferences, and there are small travel models as well.
“We recommend a custom device made by a dentist,” Dr. Benjamin said. “And you should be retested to see how well it’s working. There’s subjective and objective improvement that should be tracked.”
But there are people for whom neither CPAP nor dental appliances work, either because they cannot use them consistently or correctly, or because the devices themselves do not solve the problem even when used properly. For these patients, there are various effective surgical procedures.
The most common is soft tissue surgery, which involves modifying or excising tissue at the back of the mouth. Depending on the structures and musculature of the mouth, the surgeon can trim the soft palate and the uvula, remove the tonsils, shrink tissues with a heated instrument, straighten a deviated septum, or alter the position of the tongue muscles, all with the aim of improving air flow.
There are also bone surgeries that move the jaw forward to make the entire breathing space larger, a procedure that can involve a protracted recovery period.
In 2014, the Food and Drug Administration approved a device called Inspire Upper Airway Stimulation. This is a small appliance implanted under the skin like a heart pacemaker. Using two electrical leads, it senses the breathing pattern and stimulates the nerve that controls the tongue to move it out of the way and allow air to pass freely. Implanting it is a day surgery procedure that takes about two hours.
“It doesn’t change the anatomy, and recovery is easier than with other surgeries,” said Dr. Maria V. Suurna, an associate professor of otolaryngology at Weill Cornell Medicine who specializes in surgery for sleep apnea. “It’s effective. It has the lowest complication rate of all the surgeries.
“But it’s not for everyone. It’s approved only for adults 18 and older who are not overweight and who have moderate to severe apnea.” Some people may be ineligible because of the structure of their anatomy.
“Surgery is tricky,” Dr. Suurna said. “But there’s no ideal treatment for apnea. Each has pros and cons, benefits and risks.”
Suffering from sleep apnea can not only disrupt your sleep, but it can be a serious health problem. This is why it’s important to get diagnosed so that you can get the treatment you need. One of the treatments that many people choose is an oral appliance. For many, this is much easier to use than some other available therapy options.
But, as with many medical treatments, the cost can be an issue. Although you have health insurance, many people still wonder, what do insurance companies consider oral appliance for sleep apnea? Let’s answer that question and look at some of the issues surrounding sleep apnea.
What is Sleep Apnea?
If you are diagnosed with sleep apnea, this means you pause when you’re breathing during sleep, or there is a reduction in your breathing. If someone stops breathing completely or takes less than 10% of a normal breath for ten seconds or more, they are experiencing an apnea or obstructive sleep apnoea. If you are experiencing sleep apnea, you may suddenly wake up or move from a deep sleep to a more shallow sleep.
To determine if you have sleep apnea, a sleep study is generally needed. During a sleep study, sleep patterns are monitored to see if someone stops breathing during the middle of the night and at what frequency. This will help doctors determine if they have sleep apnea and what type. From there, the proper course of sleep apnea treatment can be devised.
Once you’re diagnosed with sleep apnea, it’s time to get treatment. Oral appliances are a popular option over using a continuous positive airway pressure (CPAP) machine. Some people find these CPAP therapy machines to be noisy and intrusive.
Oral appliance therapy works to treat sleep apnea by moving the lower jaw forward to open the airway and unblock the windpipe, which can improve breathing and lead to a better night’s sleep. FDA-registered oral devices can be used to treat sleep apnea when they are given by a qualified dentist trained in dental sleep medicine. At Sleep Better Columbus, we can help you find the right oral appliance to treat your sleep apnea and get you a better night’s sleep.
Insurance and Oral Appliance Treatment for Sleep Apnea
Since all insurance companies are different, you’ll need to contact your specific insurance company to make sure that you are covered for an oral appliance for sleep apnea. Generally, plans will at least cover a portion of the cost.
Most health insurance plans consider oral appliances or dental appliances for sleep apnea as a piece of medical equipment. This is why they will cover it. There are more than 100 FDA-approved oral appliances available to help treat sleep apnea. Your insurance may specify the type of oral appliance that they will cover instead of letting the doctor and patient choose. These are things you will need to ask your benefits department.
To get coverage for an oral appliance for sleep apnea, you’ll have to show that you suffer from the condition and not just chronic snoring. A copy of the sleep study and any medical notes from your sleep apnea screening appointment is also necessary. Your medical history will also be considered. Some insurance companies may also require other documentation, so it’s best to ask so that you are prepared.
Of course, for your insurance company to pay for an oral appliance for sleep apnea, it needs to be prescribed by your doctor. The insurance company will need to see that documentation to provide any level of coverage.
Although the equipment goes in your mouth, an oral mouthpiece is treated under your health insurance, not your dental insurance. The device is being used to treat a medical condition, not one that is specific to your dental health. An oral appliance is seen as a piece of medical equipment because it can be used to improve your health.
When people begin using oral appliance treatment for sleep apnea, they can also help to avoid serious health problems such as:
High blood pressure
Stroke
Diabetes
Heart disease
If you have a medical history of any of these or a family history of them, it’s important to get treatment for your obstructive sleep apnea as soon as possible.
This is a difficult question to answer because there are so many oral devices for sleep apnea available. Since they are custom-fit to each patient and everyone may choose something different depending on their condition, it’s best to ask your doctor which ones are best for you. From there, you can price them out and get a better idea of the cost.
Once you have an estimate, you can find out how your insurance may cover it. This will also vary depending on your plan. If you have a deductible, this will come into play, as well as if you have any co-insurance. Many times patients do need to pay for a percentage of the cost. But, the exact dollar amount will depend on your insurance coverage.
Contact Us!
When you need an oral appliance to treat obstructive sleep apnea (OSA), visit Dr. Mark Levy at Sleep Better Columbus. Dr. Levy is trained in treating sleep apnea and can recommend dental appliances for sleep that can help. Let Dr. Levy and his dental sleep staff show you the alternative to CPAP machine to improve the quality of your sleep.
The dental sleep medicine staff at Sleep Better Columbus can help you find an oral device for sleep apnea that your insurance will cover so that you can get your obstructive sleep apnea under control. Once you do, you’ll notice you’re getting a better night’s sleep as well as an improved quality of life. When you have your sleep apnea treated, you’ll feel energized and healthy.
Call Sleep Better Columbus today at 614-362-7292 to find out more about oral appliances to treat your sleep apnea.
Sleep is a vital component of every person’s health and well-being, especially for sleep apnea patients using an oral device to get adequate sleep. We recently received questions from patients about the safeguards one can take to properly disinfect their device and how to avoid potential misuse that could damage the device. To help clarify how to use the device properly and prevent damage to the device we have put together this resource so users can wear their device every night with confidence.
FAQ
Should I be concerned about handling the device with my hands? You can insert or remove your device with your hands, but make sure to wash your hands thoroughly beforehand for at least 20 seconds. You can find the video about handwashing from CDC on https://www.youtube.com/watch?v=d914EnpU4Fo.
Can I disinfect the device with alcohol? No, do not use alcohol on the device. Alcohol is a drying agent and can damage the material of your device, making it more susceptible to cracks. We also advise against putting your device in the microwave or heating it to “sterilize” it as this will only damage the device.
Can I keep the device in the water? Whether you store your device in water or not depends on your device. Check your box for instructions. Most oral devices should be stored in a dry area that exposed to air and sunlight to prevent the growth of germs.
Should I be concerned about the hygiene of the device if I left it exposed to open air? Washing your hands before inserting or removing your oral device, as well as properly cleaning and storing the device would prevent such contamination. According to the CDC, the virus is thought to spread mainly from person-to-person, either between people who are in close contact with one another (within about 6 feet) or through respiratory droplets produced when an infected person coughs or sneezes.
Sleep apnea affects millions of people every year. Currently, around 25% of the American population is diagnosed with sleep apnea. It’s so popular that innovators have come up with a ton of ways to help. Using mouth devices for sleep apnea treatment is quickly growing in popularity. The symptoms associated with this sleep disorder cause unpleasant side-effects, and no one wants to go through life like that.
Sleep Apnea Treatment Options
Sleep apnea can cause a variety of “scary” side-effects and diseases, but let’s look at the big two: snoring and fatigue. Mouth appliances are effective in getting rid of these popular side-effects. When they’re FDA regulated and designed with apnea in mind, they can help you feel 100% better. Different devices work for different people. Today we’re going to be covering the 3 most popular mouth devices for sleep apnea. After reading, you will be better equipped to decide which one is right for you.
CPAP
The CPAP is by far one of the most notorious when it comes to sleep apnea relief. When most people think of apnea, they connect the disorder to the CPAP machine. The CPAP operates with a simple concept in mind: to allow you to sleep better by blowing a steady stream of gentle air into your mouth and nose. The CPAP machine is pretty small and it plugs right into your wall. You use it by placing the mask over your nose and mouth and turning it on every single night before bed. When used correctly, it should prevent you from interrupted breathing.
While the CPAP machine can be effective, it’s also inconvenient for some. Here are some common complaints:
Stomach issues
Congestion
Nosebleeds
Feeling claustrophobic or confined while sleeping
Sores inside the lining of your mouth
Reports have been made about chest pain while using
It isn’t ideal for sensitive skin
Irritation for your partner or pets
It is unpleasant if you have a cold or sinusitis
Requires regular cleaning
It’s uncomfortable
Some people don’t experience any of this. It can be very useful. It is not, however, the least-invasive form of treatment. The following mouth devices for sleep apnea treatment are quickly growing in popularity.
Mandibular Advancement Device (MAD)
Sleep apnea isn’t just caused by bad health. While it is often associated with diabetes and poor diet, other factors come into play. Sometimes it’s genetics. Sometimes it has to do with the alignment of your jaw or the size of your airway. Mouthguards will prevent snoring and help to open the airway. The Mandibular Advancement device is very similar to a mouthguard. The MAD kind of looks like the mouthguards that football players wear to protect their teeth.
This particular device is pretty bulky. It is meant to snap onto the top and bottom of your teeth. It’s equipped with metal hinges that make your jaw move slightly forward while you sleep. This can open up your airway quite a bit.
Tongue Retaining Device
The tongue retaining device can be a little uncomfortable. It’s a “splint” that attaches to the tongue, forcing the airway open while you sleep. It may take a little getting used to, and it may initially cause some irritation. It is usually made from medical-grade materials, especially when purchased from a reliable source. (Remember: only buy mouth appliances that are FDA approved.)
The retaining device looks a little bit like a tiny octopus. You slip it onto your tongue and the end of it balloons out past your lips. It may look a little silly, but it does the trick. Again, not exactly a “romantic” option, but it may be more comfortable for some people than a CPAP. This device has drawbacks, as well. If not attached properly, it will slip out of the mouth. This renders it ineffective. It can also be a little hard to swallow when wearing a tongue retaining device. This can make it tricky to get a good night’s sleep. On top of that, it collects spit and needs to be cleaned daily. Storage for this device is simple. You place it into a container when you’re finished using it. You do the same thing if you’re using a mandibular advancement device.
Consistency is Key When Using Mouth Devices for Sleep Apnea
No matter what device you choose to go with, you have to be consistent. These devices work on a night-by-night basis, which means if you skip a night, you’re risking the side-effects of the disorder. Don’t stop using your device right away when you start feeling better. Continue to use it unless directed otherwise by a health care professional.
Keep in mind that all mouth appliances need to be worn properly. The CPAP, for example, will not work if it is not clipped on just right. If you ever need help with fitting your CPAP on correctly, see your dentist or doctor. The same goes for all of these appliances. If your mouth device feels uncomfortable, you may be wearing it wrong. If you aren’t getting any symptom relief, you may just need to adjust how you’re using your appliances. This is manageable.
You can buy these devices online. They’re popular. The problem with this is a lack of information and an improper fit. Getting someone to fit you for a device is the best way to stay comfortable at night. When you go to a professional for your device, you know that they’re doing what they can. They work to get rid of the symptoms of your unique sleep apnea. These devices aren’t always a “one-size-fits-all” deal. It’s important that you find something comfortable. After all, you’ll be sleeping with it every night!
Stay consistent when keeping in touch with your health care provider/dentist. Keep him/her apprised of your progress (or lack thereof). Don’t hesitate to call if your appliance isn’t working or if it’s too uncomfortable to sleep with. Your dentist or doctor will know how to help.
