Many of you have commented on how exciting you find the invention of the Airing micro-CPAP device. We are gratified by the reaction and your enthusiasm to join us in our effort.
You have asked some good and important questions. This FAQ page will start to answer these questions and hopefully give you a deeper understanding of what we’ve done and what we plan to do. Our goal is to keep you informed and motivated to help us realize this revolutionary improvement in the treatment of sleep apnea on Indiegogo.
Will Airing be comfortable and stay in my nose?
Answer: A key component of Airing’s micro-CPAP device is what we call the "nasal interface," a fancy way of saying nose buds. We have designed, built and tested this component while integrated to a test housing. This test housing allowed for normal breathing straight through with no micro-blowers and allowed us to simulate the size and weight of the proposed completed device. Various nose bud designs were evaluated.
Going in, we had high expectations.
As you can imagine, we wanted a lot from the Airing design. We wanted Airing to be inserted easily with one hand. We wanted the nose buds to form a seal within the nose that could maintain the treatment pressure. We wanted it comfortable enough to allow the user to fall and stay asleep while wearing it. And it had to remain in place through the night.
After a number of iterations, we arrived at a design that accomplishes all of these goals. Testing with multiple subjects demonstrated easy one-hand insertion with little, if any, need for adjustment. The passive breathing channels in the test housing were intentionally blocked to test for sealing. Even when the exhalation pressure exceeded the maximum pressure produced by existing CPAP machines, the seal was maintained.
Without comfort, we knew we'd have nothing.
The nose buds are molded from a soft and pliable silicon rubber material. Their shape provides a gentle and flexible seal with minimum exposure to the surface of the nasal pathways. To assure accurate fit and maximum comfort, the device is intended to be available in a range of sizes to accommodate different nostril shapes.
Our test subjects indicated they found the device comfortable enough to fall asleep and stay that way until a normal awakening, such as going to the bathroom. At which time the device could remain in place until they returned to bed. Upon waking in the morning, they removed the device and rated their experience.
Continued adjustments in the shape and materials of the nose buds has further improved retention and comfort. The amount of material within the nose was minimized as the shape evolved. In one case, the subject indicated he actually breathed easier with mitigated snoring even though the device was passive (a non-working prototype), perhaps a beneficial side effect of a slight opening of the nasal pathways.
We are good to gogo.
We will continue to improve the fit and feel of the nasal interface, but our current design will allow us to perform effective testing of the micro-blower component prototypes when they become available after a hopefully successful Indeigogo fund raising campaign.
Can Airing produce the same air pressure as traditional CPAP machines?
Answer: The pressure generated by the typical CPAP machine ranges from 1 to 20 centimeters of water (cmH20), known as the treatment number. A doctor or sleep technician tests the patient to determine the appropriate treatment number.
The Airing device has been designed to generate the full range of treatment pressures up to and in excess of a treatment number of 20. This is possible because of the strength of the electrostatic force that drives the micro-blower plates, like bellows, open and closed, together and apart. Each micro-blower can push a small amount of air at significant pressure, and hundreds of micro-blowers work in parallel to achieve the required volume to effectively treat the particular patient’s sleep apnea.
Airing devices will be available initially in a range of pressure values so that you will be able to obtain the device with the treatment number prescribed for you, much like contact lenses. Eventually, we intend to make our devices adaptive so that they will self adjust (like some current high-end CPAP machines) to provide the exact pressure for effective treatment.
Will Airing require additional humidification like current CPAP machines?
Answer: The Airing device has been designed so as not to require active humidification. The human nose has evolved to filter the air it breathes in through a pathway with tiny hairs and to humidify this pathway with every exhalation. This system works well if the normal tidal volume is exchanged. When excessive air is blown continuously into the nose, the entire pathway can dry out and become quite uncomfortable; this is not natural breathing.
Traditional CPAP machinery requires a motor and a fan or blower cage to blow large volumes of air down a hose and into a mask or nose pillow. The inertial mass of the motor/fan/blower assembly and the length of hose prevent the rapid (instantaneous) adjustment of the air flow to respond to the actual breathing cycle. BiPAP and APAP systems do have the ability to reduce the total amount of air being pushed at the patient during exhalation, but only to a limited extent.
The Airing device will have built-in pressure sensing and will be able to adjust the micro-blower output instantaneously. This ability to respond to where a person is in the breathing cycle eliminates the need for excessive air flow. This allows more natural breathing and mitigates or may even eliminate the need for additive active humidification. Passive humidification is possible if desired.
How much will Airing cost?
Answer: The short answer is $3 per Airing device, or $0.60 after insurance reimbursement. But it's important to understand the technology behind Airing to appreciate how we plan to produce the device at such a low cost per unit.
The invention of the micro-blowers is the technological breakthrough at the heart of the Airing micro-CPAP device. The power source is based on a similar technology Polaroid used in their film packs because it is powerful, mass manufacturable and inexpensive. The integrated electronics are analogous to those in the Kodak disposable cameras. Again, small, mass manufacturable and inexpensive. The rest of the device is low cost rubber and plastic. Each component is small, inexpensive and integrated, so the aggregate result is a very small, highly efficient, tightly integrated device.
The Airing device is designed to be mass manufacturable so as to reduce the cost and allow it to be a single use device. Both the micro-blower technology and the power source can be made using the roll to roll process, an extremely efficient system. The integrated electronics takes advantage of semiconductor processing that is well proven in low cost consumer product manufacturing. The rubber and plastic parts use high speed injection molding, again very cost effective.
By adopting the best design and manufacturing practices from successful consumer products in the areas of health and electronics, we are able to deliver a device that has an end user price of about $3.00, making it inexpensive enough for single use.
We are hopeful that the FDA will view the Airing device as a variant of the existing accepted CPAP therapy and clear its sale as such. If they do, then it is reasonable to believe that the insurance companies who provide reimbursement for this type of equipment and treatment will do so for the Airing device. If the customary reimbursement rate of 80% is available, this would reduce the cost of the Airing device to the consumer to approximately $0.60 per day.
Prove your compliance to your insurance company.
The integrated pressure sensors and electronics that control the Airing device are able to track the patient’s breathing cycle and deliver the proper treatment. The appropriate data can be stored for subsequent retrieval. This built in feature can be used for proof of compliance. That will help with reimbursements.
How long can one Airing device run before the power is exhausted?
Answer: We have designed the Airing device to provide eight hours of treatment before the energy in the battery is consumed. Several design choices were made to reduce power consumption and thereby extend the run time.
Electrostatic actuation of small moving structures has proven to be the least power hungry, most efficient drive mechanism, and this is what we use to move the micro-blowers.
The Airing device is designed to direct all the air being moved by the micro-blowers into your airways. During inhalation, no air is lost out the exhalation vents as in other designs. The air movement through the micro-blowers can be controlled dynamically, adjusting to the breathing cycle, so as not to waste unnecessary energy blowing against the exhalation.
This combination of design and operational control minimizes power consumption, allowing a highly energetic Zinc-air battery to store eight hours of energy in a small and lightweight package.
How will Airing deal with mouth breathers?
Answer: Nature’s design of the nose is outstanding. In normal circumstances, the default position of the mouth is closed. When nose breathing is diminished or obstructed, nature provides a backup: mouth breathing.
But mouth breathing can cause snoring and dryness, which are uncomfortable and unhealthy. We believe that improving nose breathing will significantly reduce or eliminate mouth breathing.
The nose buds of the Airing device are molded from a soft and pliable silicon rubber material. Their shape provides a gentle and flexible seal with minimum exposure to the surface of the nasal pathways. Our research with a non-working prototype showed that the very comfortable nose buds even had a beneficial side effect of slightly opening the nasal pathways, which itself aided correct breathing.
In short, we believe the design of the Airing device will be helpful for many mouth breathers.
Is the Airing device FDA approved?
Answer: No, not yet. However, we do believe the process of getting FDA approval may be abbreviated. Here's why.
The Airing device does not provide a new treatment. The Continuous Positive Airway Pressure (CPAP) treatment has been around and used with FDA approval for years. The Airing device merely miniaturizes existing machinery into a portable and comfortable format.
We hope, although we obviously cannot guarantee, that the FDA would agree that the device is a constructive modification of an already approved treatment and be willing to approve its use on a timely basis.
Therefore we plan to explore the possibility of an abbreviated approval process known as 510(k) clearance, which would allow us to accelerate approval (months versus years). If this is not feasible, we would pursue the standard Pre-Market Approval route.
We will get there one way or the other.
Why not power Airing with a rechargeable battery?
Answer: We considered several key factors in designing the power source for the Airing device: power per weight and volume, ease of manufacture, cost, and environmental impact. The Zinc-air battery was the clear winner in all categories.
The Zinc-air battery provides about ten times more stored energy in the same space as the same-sized Lithium-ion battery. In fact, a rechargeable Lithium-ion battery that could last through the night would make the device too heavy for convenient and comfortable use, our primary concern.
Zinc-air is a proven and inexpensive technology. It was used for years in Polaroid film packages and can be manufactured cost effectively using the roll to roll process. And unlike some of the other caustic, more corrosive, battery technologies, the Zinc-air is environmentally benign — basically a common metal and soap.
A future design may use a power source that is rechargeable without being excessively bulky or heavy. We would all welcome such an improvement. But today, Zinc-air is the best choice to get a working Airing device into the hands of those who are desperately seeking relief from traditional CPAP machines.
Why is Airing funding itself through Indiegogo crowdfunding?
As many of you know, we have chosen the crowdfunding platform Indiegogo to raise the necessary funds to produce the proof-of-concept prototype for Airing. Many of you have asked why we didn't go the more traditional routes like venture capital, selling the company, or finding other investors.
My name is Phil Huyck and I am the Chairman of Airing. I'd like to answer this question because it's an important one.
The short answer is this: we chose Indiegogo over other financing options because crowdfunding is the best way to align the needs of our company and its innovative improvement in CPAP technology with the interests of those who will be the direct beneficiaries, the sufferers of sleep apnea.
We carefully considered all our options.
We held conversations and went through significant due diligence with various potential funding sources. Institutional investors tend to have a short-term time horizon. And, at present, they are sadly not particularly enthusiastic supporters of innovative health care devices.
Crowdfunding was different.
Until the advent of crowdfunding, individuals who could benefit from new technologies like Airing had no say in what was being developed. With crowdfunding, the benefitting constituency can be in voice directly for the first time.
A standard tool in looking at innovation is the optimum risk/reward ratio. Crowdfunding is the right approach and Indiegogo is the right place to achieve that. The financial risk to any individual Airing contributor is small. The reward is large — access to a new life with a convenient and useable treatment for a serious affliction.
Airing’s micro-CPAP device has significant potential long-term benefits for the treatment of tens of millions who suffer from sleep apnea. With our Indiegogo campaign launching next week, you have the chance to help make Airing real for you and your loved ones. The future is in your own hands.