Vibralung® Acoustical Percussor receives FDA 510(k) Clearance

wpierson7

New member
No problem! We live in Arizona, where the company that sells the product is based. The nurse was able to drive up to Phoenix from Tucson. She told us that the device costs $2K as well (if insurance refuses to pay), and that they have a payment plan. The mouthpiece appears to be made of plastic; similar to the type found on nebulizer machines. I am uncertain if it can be boiled. My dad does not have cystic fibrosis - he has COPD. But his pulmonary doctor thinks the device could be useful. The nurse who provided the training repeatedly mentioned that we could easily send it back without charge if it did not work out. So it may be worth it to you to give it a shot. I'll keep you updated!
 

LittleLab4CF

Super Moderator
I need to hurry up. Last year two products I was developing suddenly hit the market which meant I was at least a year behind. Vibralung or something acoustic to replace the pelting of a vest has been something I hit on about six months ago.

In a former life I was doing digital signal processing professionally and digital media was a rarity. I met my wife who was my boss then. She took a two year contract to write digital modeling software for another company and the software could model any middle ear to a concert hall design.

I began by running tests on a variety of mucus and mucus like material directly vibrating a plate the mucus is stuck to. Certain frequencies will cause the mucus to literally fly off the vibrating plates. No vibration pattern caused it to adhere better. The concept of air vibrating with and through breathing is compelling. The whistle like flutterer causes stops and starts in breathing and sort of works on a limited but similar basis to Vibralung. It hopefully accomplishes the same results as a vest only better and easier. There are sympathetic frequencies that could virtually atomize mucus and phlegm.

Best of luck, we'll be waiting,

LL
 

mmcpeck

New member
Hi all - I received an email from this message board that there were follow up questions from a number of you. I have been preoccupied with conducting some all-day training sessions this week but should have some time later today to read all the questions and provide answers. We appreciate your interest in the Vibralung Acoustical Percussor and want you to be informed. By the way, the "believingjesus," our web site was in maintenance mode over the past weekend, and I suspect that's when you were unable to access it. But it is up and running now, and we are getting ready to update it soon with new cleaning instructions, testimonials we have received, and other information. That could happen in about another week and I will post here when the changes have been made. I'll be back later with answers to all your questions. Thank you.

Michael McPeck, RRT FAARC
Director, Clinical Education
Westmed, Inc.
Tucson AZ
mmcpeck@westmedinc.com
vibralungACT.com
westmedinc.com
 
Little Lab - that is so cool that you were working on that before! Do you really feel it is better than the Vest? I would really love for my son to have one but when I read the instructions on cleaning it talks about using wipes or soap and water in parts and to be sure not to get it in the crevices. This makes me believe that bacteria could get in the crevices or stay on the part that just says to use Clorox wipes or soap and water. I honestly know soap and water are not sufficient to kill most bacteria people with CF culture. Unless I am missing something, which is highly possible - :eek: -, I feel they should have fixed this problem before they manufactured it if they were aiming to help people with lung diseases like cystic fibrosis.

wpierson - I didn't notice last night that you had replied, sorry! I appreciate you letting us know since your dad actually has this device. I really hope it works well for him. I am sure it is an excellent device, I am just unsure about the sterilization for people with cf because of the various bacteria that is in the lungs of most people with cf. I didn't know that they would let you try it on a trial period. That is super for your dad but again makes me question the sterilization if they could then let someone use it with cf and then let someone else use it??? I'm just super paranoid about everything so this is natural for me. I appreciate you keeping us updated as to how it is working for him! Thanks so much!
 

LittleLab4CF

Super Moderator
When I looked at the pictures of the Vibralung, I was somewhat surprised that the acoustic driver, the speakers if you will, are integrated into the mouthpiece. The concept of using sound inside the airways and lung is fantastic, and it sounds like it has been tried when the technology wasn't as advanced, which is a good thing usually. The sound can be percussive just like the pummeling action of a vest without having to pass through the body and lung tissue to get to the mucus. In effect the percussion or whatever vibration pattern is impressed into our airways hits the mucus first instead of last. Far less trauma should be one major result because it is in direct contact with the mucus and airway surfaces.

In theory, with what my wife and I know about acoustic modeling we know that a resonant frequency for our thick, sticky mucus and phlegm is possible to hit. When resonance has mucus gyrating, it can be literally atomized and nothing would be easier to expectorate.

Although it was one of the more mysterious and oddly reported stories Nicola Tesla pioneered resonant frequency and reportedly did substantial damage to the steel beamed building housing his laboratory. Tesla had a toaster sized box bolted to an I beam and it was oscillating everything from the beams to the bricks. The story breaks down at a point where the infernal machine was stuck on maximum and Tesla was found beating his equipment with a sledgehammer, yada, yada... The point is that sympathetic vibration and acoustic resonance delivered in the form of a percussive pulse has the potential for more effective and possibly pleasant variety of frequencies to literally jiggle the mucus off of whatever it's stuck to. Impressing energy in the form of friction into the tiniest amount of mucus heats and thins mucus. Potentially with an acoustic model of the lungs for each person, extracted from a chest CT, percussive pulse patterns could hit specific mucus densities and the internal structures in the lungs with specific diameters.

Obviously I am excited about the technology, I really have experimented with mucus and its response to sound frequencies. There is tremendous potential in computerized, sensor monitored acoustic therapy. Everyone who knows the issues behind sterilization and the company will solve it. If there is an issue with cleaning or anything reasonably fixable, 99.9% of the work has been done. As a guess.

LL
 

ethan508

New member
LL from your tests, what was the natural frequency range of phlegm? How does that compare to the natural frequency of the lungs?
 
Little Lab - I appreciate your response on this as you are so knowledgeable about things and really put your all into it.

I understand that the company probably thought of this and all that, however, I did talk to a representative of the Vibralung and he basically said the same thing the website says - if mucus or sputum gets on a part of it then you just wipe with Clorox wipes or rinse with soap and water. Also wpierson who responded on this thread and already has one for his/her dad that has copd said the same thing that if sputum or mucus gets on a certain part then just rinse with soap and water. To me that is not adequate sterilization. When nebulizers have to be boiled for 10 minutes or placed in isopropyl alcohol for at least 5 minutes - I do not see how if mucus gets on a part of it that it would be safe to continue to use. This also brings to mind those spirometers or whatever they are called that a person with CF blows into to test their lung function when they go to clinic. I have questioned that before too and got an unsatisfactory response as to how that is sterilized.

I wish mmcpeck could respond to this thread as I suppose he is a representative of the company but I guess he is very busy. I would love to get a Vibralung but unless I can resolve how a device that is put in the mouth can be sterilized I will have to look at something else. To me, every person with CF should consider that before looking into a Vibralung. It sounds absolutely wonderful if it truly can be cleaned (sterilized).
 

Rosie55

New member
This is an excerpt from the website on cleaning. I have a 21 year old daughter with CF and I think this could work really well for her. I'm calling the company to set up a trial. From what I understand they will give you a 30 day trial and then assist with insurance or set up a payment plan. However I'm not really sure what it costs so I'm hoping to get all questions answered, including cleaning, when I call and they set us up for a trial. I'll share my experience.

"The HHT is a single-patient use disposable device that is designed to be used for the duration of a patient’s hospital stay, but not to exceed 30 days. It is supplied non-sterile.To clean the HHT, remove the Y-adapter, mouthpiece, variable expiratory resistor and screw-on cone. Remove Circulaire, if present. Clean the outside surface of the HHT and the transducer diaphragm with a pre-moistened germicidal wipe or cloth product containing dimethyl-benzyl-ammonium chloride and/or dimethyl-ethylbenzyl-ammonium chloride. Allow the appropriate contact time as specified by the product’s instructions. Allow the surface to dry before reassembling and using.Clean the Y-adapter, mouthpiece, variable expiratory resistor and screw-on cone with soap and water, rinse, and then disinfect the parts by soaking in alkyldimethyl-benzyl ammonium chloride for 10 minutes. Rinse with sterile water and allow the parts to air dry. Remove the nebulizer and clean according to the nebulizer care instructions."
 
Thank you Rosie. If you could let me know how it goes for you I would really appreciate it. It really looks like a device that could really help. I wish someone from Vibralung could respond on this forum as to the sterilization. I am not worried about the outside components of the device, only the inside. I read something different than what you posted and I was pretty sure they were talking about the inside components and it said to use a Clorox wipe on that part. The Vibralung is $4,000 but if insurance does not cover it then they charge $2,000. I appreciate if you could share what you find out. Thanks so much!
 
My daughter has this and loves it. They will be using her response and feelings of what she thinks. We have seen a difference in the mucus moving around. I just saw they did tweets to it based on feedback and we are excited to see the difference.
 

mmcpeck

New member
I'm sorry to have not answered the questions so far. As I stated earlier, I have been involved in training sessions and some other activities this past week, and haven't had a spare moment to sit and respond. However, I am flying from Los Angeles to Long Island on Monday 3/9 and plan to use the flight time to answer all of your inquiries about the Vibralung and, particularly, its cleaning. Also, this coming week, I will be updating the web site to include information about the change that was made to the frequency generating software and the availability of a "change kit" that allows certain parts of the device to be discarded and replaced at appropriate intervals. More to follow.

Quick response to ethan508 - The lung doesn't have a single resonant, or natural, frequency. Instead, it has many. Each time airways branch into progressively smaller airways, each of those airway segments has a different length, diameter, resistance, compliance and other factors than the previous airways. This means that the frequency required to vibrate those airway segments keeps changing. Consequently, the Vibralung lung steps through a wide range of frequencies, from lower to higher, divided into 3 different ranges for convenience, in order to gradually vibrate all airways at or near their resonant frequency. The operating theory is that the gas in the airways is vibrated by the sound waves which, in turn, vibrate the airway structures by sympathetic resonance. This is the same reason your windows vibrate when you turn up your stereo too loud. The sound waves vibrate the air in the room which, in turn vibrates the windows by sympathetic resonance. When the airways vibrate, shear forces occur at the boundary between the mucus and the airway surface, just like when you cough effectively.

Michael McPeck, RRT FAARC
Director, Clinical Education
Westmed, Inc.
Tucson AZ
mmcpeck@westmedinc.com
vibralungACT.com
westmedinc.com

 

charliej5

New member
I am a COPD victim. Like many others, I am plagued with sticky mucus which severely restricts my airway. I do have, however, an excellent aid - SSKI (Saturated Solution Potassium Iodide). I mix 3 mL with 3 mL of Ipratropium/Albuterol in my nebulizer about 4 times per day. Within 3-5 minutes I begin to expectorate the mucus and in 40-50 minutes I am breathing freely and comfortably.

This prescription item is manufactured by Upsher-Smith. I buy the 237 mL (8 ounce) bottle at Sam's at a cost of $105.00.

The uses are numerous. Here is a good link for overview: http://www.olaloa.com/the-healing-power-of-potassium-iodide-sski.html

I hope this is beneficial to some.
 
MMCPeck: I thought you had said a few weeks ago that you would reply as to the cleaning of the Vibralung? I have been looking since then and have not seen a thing. I am sure I am not the only one. When you have a group of people that supposedly this device is made for that look on this forum and consider purchasing it - why wouldn't you address this? I know that it would take about 5 minutes to let us know about the INSIDE cleaning of this device as to whether it is adequate or not for CF and also it would give you an opportunity to promote your product. ???????
 

UsualSuspect

New member
Believingjesus,

I don't see any reason why the plastic pieces can't be soaked in isopropyl alcohol or hydrogen peroxide, the only 2 cold cleaning methods left that the CF Foundation still endorses to disinfect. From browsing the site, it'd be the clear plastic pieces in the box on the right:

http://westmedinc.com/wp-content/uploads/2014/07/VL-Parts-ID1.png

The Clorox wipes would simply be for the box and that hair dryer looking thing with the speaker that says HHT.
 

LisaGreene

New member
We have one for my two teens with CF. They share the base but each have their own mouthpieces. They love it. They use this WITH the vest (they use Smartvest) and when they travel (my daughter just returned from Hawaii for a week for spring break with another family), its SO easy. She soaked it in alcohol to clean it but when we are at home, we use a baby bottle sterilizer and it works just fine (nothing has melted yet). We boil everything usually so I understand the need for good cleaning and I feel okay about it with the sterilizer and the alcohol when traveling. It is a little loud, be aware of that, but I guess the vest is too.

I think that having a variety of airway clearance options are great. We also use the accapella (looking into the new Aerobika, too) as well as flutter and hand CPT. I like the Vibralung because it is a different kind of therapy, from the inside out. Its a great addition to our medical cabinet.
 
One of the private messages I received late last night said that a person on this forum was told by a representative of the Vibralung company that they would charge them $3,200 for this device. They PM'd me to ask which representative I talked to at the Vibralung as I was told $2,000 if insurance did not pay. I feel the absolute need to post as this is not fair that one person would be told one thing and a different representative or possibly the same one would tell someone else another price. I was told by a representative of the Vibralung that if insurance did not cover this device that it would cost $2,000 - not the $4,000 the company is charging originally. That price should be the same one offered to ALL people. Also I was wanting to ask the people that have this device already and use it a question as UsualSuspect posted pics of this device. The part I was always worried about the sterilization was the HHT part. As UsualSuspect noted - in order to sterilize any part used in the mouth they would have to be boiled at least 10 minutes or sit in 70% Isopropyl Alcohol for at least 5 minutes. To me if you are using the HHT device on more than one person and mucus gets in the HHT part it can grow and then the next person to use it would also get that bacteria. So I do not understand the policy of the company to let everyone try this device for 30 days and if they do not like it they can return it. Makes me nervous for the next person who gets the device. I appreciate your explanation of cleaning MMCPeck but I just still don't understand how the HHT part is truly sterilized. My son is supposed to talk to his doctor about this device at his next appointment in May so I would still very much like to know. Thank you!

Also I wanted to add as an edit: I appreciate your time and patience MMCPeck. I am very interested in the Vibralung so that is why so many questions. If you could also let us all know what the price would be if insurance does not cover it as I was told one price and another person was told a different one. I really appreciate your time. Thank you so much!
 
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L

lifeisgood729

Guest
I was the person who contacted believingjesus about the price confusion, but i was able to speak to a sales rep at WestMed directly, and they straightened it out. I have met MMcPeck, and I don't believe there is anything unfair going on. I think it was just a miscommunication. This is a fairly new device, and so there might have been some confusion about pricing when they first released it? There are only two providers who are selling the device in the US, and I think they are both selling for $3200 if your insurance won't cover it.

I tried the device in my home and I think it would be a good addition to my airway clearance routine. I also like that it's small enough for travel, since I don't bring my Vest with me when I travel. I'm going to try to get the device covered by my insurance company. The mouthpiece has a sort of filter on it to stop mucus from going into the device, and it can be sterilized in alcohol. It's also a disposable piece, so you only use the mouthpiece for a while before you replace it.

If I get the device, I'll let you all know how I like it.

Martha
47 w/CF
 
Martha: I'm glad you found out the final price if insurance did not cover. I was told $2,000 so I sure hope our insurance covers it when and if we get a prescription for it from the doctor as I can't really afford the extra $1,200. I appreciate you letting us know how it works for you. Maybe I just have to see the device up close to realize no mucus could get in the HHT? I still am not confident though because of that part but it sounds like a wonderful device that would really help. Thank you Lifeisgood!

Also Martha - thanks for the PM just now- I just saw it after I posted here. I hope it is covered for both of us. My insurance company had said at one time it would probably be covered somewhat if we get a prescription but they can not say for sure until it is submitted. Good luck to you!
 
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ecsnut

New member
What if you don't have private insurance. Is it covered by Medicare or Medicaid or state funded insurance. Who is carrying it.
 
L

lifeisgood729

Guest
I spoke to the owner of SleepRxonline, one of the two places carrying it. She said Medicare likely won't pay for it, because the billing code is listed as "miscellaneous" and Medicare doesn't usually pay those. I don't know about Medicaid. I have a secondary policy that she seems to think will pay for it. The good news is that she will do the work of filing for payment with the insurance company. I received a list of records I need to get from my doctor, as well as a letter of medical necessity, so she obviously knows how to go about trying to get the device covered.

I would recommend that anyone curious about the device contact the company directly for more information.

Martha
 
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