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Breaking news – A potential game changer for patients with profound oropharyngeal dysphagia

Breaking news – The Swallow Expansion Device (SED) – a potential game changer for patients with profound oropharyngeal dysphagia. In early January 2015 the SED was implanted into Jeff Mauerman, a cancer survivor who is feeding tube dependent due to oropharyngeal dysphagia. This is the first FDA Approved Clinical Trial that allows a Medical Piercing to Control a Body Sphincter (Part 1 of 2)

Byline: Ed Steger, President, National Foundation of Swallowing Disorders

Disclosure: Dr. Peter Belafsky is the Medical Director of the National Foundation of Swallowing Disorders.

[Editor’s note. This story is based on an interview between Jeff Mauerman and Ed Steger that was conducted on February 4, 2015.  This is five weeks after surgery and two months before he will know the extent, if at all, to which he will be able to swallow again.]

Like me, you may have many questions. Who’s Jeff Mauerman? What’s a sphincter? Why would one want to control a sphincter with a medicinal piercing? What does any of this that have to do with swallowing? FDA approved, really? We’ll begin with the question of who’s Jeff Mauerman.

Screen Shot 2015-06-12 at 3.10.25 PMWho is Jeff Mauerman?

Jeff spent 30 years as an electronics engineer; he is also an oral cancer survivor. Concerned about a lump in his neck, Jeff was diagnosed with stage three squamous cell carcinoma in 2000 after a fine needle biopsy revealed cancer in lymph nodes in his neck. Further examination revealed a tumor at the base of his tongue. He was treated with concurrent radiation and chemotherapy which concluded in March 2001. Due to concerns by his radiologist about his ability to maintain proper nutrition and hydration following his treatment, a feeding tube (percutaneous endoscopic gastrostomy (PEG)) tube was implanted in Jeff’s abdomen. The PEG tube was removed in June 2001 after Jeff had recovered enough to consume food and liquid orally and maintain his weight and hydration needs. Jeff did well for the next 10 years. In 2007 he had his first swallow study and the results showed a more or less normal swallow. Although the study results were unremarkable, Jeff felt food stuck in his throat just above his esophagus. An endoscopy confirmed this suspicion and the food was dislodged without incident.

New health issues began to escalate in 2011 with bouts of pneumonia, fatigue, and weight loss. His physicians suspected lung cancer due to spots on his lungs from a CT scan. Jeff underwent a lung biopsy. The good news, there was no evidence of cancer; the bad news, one of the suspected spots was food which Jeff had inhaled into his lungs while eating. That was the point at which his physicians recognized his pneumonia as aspiration pneumonia. At this time, a new PEG tube was inserted into Jeff’s stomach.

By 2013, Jeff’s swallowing became unsustainable. He had his second swallow study which confirmed aspiration. Aspiration in this case is where food and liquid enters the lungs. He met with a speech-language pathologist who prescribed a set of oral exercises. When those failed, he went through an 8 week VitalStim therapy program. A swallow study following the exercise and VitalStim therapy showed no sign of improvement.

In mid-2014, a friend of a friend mentioned success he had had in treatment of a similar swallowing issue that had been treated by Dr. Peter Belafsky at the Center for Voice and Swallowing at UC Davis. In August 2014, Jeff had a swallow study that revealed esophageal stenosis. He subsequently underwent a dilation. In layman’s terms, this procedure involves the insertion of a long deflated balloon into the esophagus where it then is inflated to help break up fibrosis and stretch the esophagus with the intent of allowing food to more easily pass down the esophagus. This procedure did not improve Jeff’s swallow enough to allow Jeff to resume eating by mouth and the PEG tube remained in place.

At this point, Jeff had lost hope that he would ever be able to eat food again. The PEG tube would become part of him forever.  A call in late 2014 changed all that. Dr. Belafsky called and offered Jeff the opportunity to consider a recently approved phase I clinical trial. If he agreed, he would be Patient One.

What’s a sphincter?

A sphincter is a valve that maintains constriction of a natural body passage or orifice and which relaxes as required by normal physiological functioning. Sphincters are found in over 60 places in the body.

What does a sphincter have to do with swallowing?

One of those 60 plus sphincters in the human body is the Upper Esophageal Sphincter (UES). As its name implies, it is located at the top of the esophagus. During a normal swallow, it relaxes and allows food to pass from the pharynx (throat) to the esophagus in a normal manner without aspirating. The pharynx sits between one’s oral cavity and esophagus. When the UES is compromised, due to radiation, injury, neurologic damage, or other causes, it blocks the natural opening of the esophagus and can cause food and liquids to back up in the throat and enter the trachea (airway). This exposes one to aspiration (food and liquid entering the lungs). Each individual is different, but varying degrees of aspiration can cause pneumonia and even death.

What is the Swallow Expansion Device?

The swallow expansion device (SED) is a small titanium implant that is planted on the voice box through a small incision in the neck. The procedure to place the implant takes less than 15 minutes and is performed without the need for sedation. The implant has a small post (piercing) that protrudes through the skin. When a person swallows, the patient pulls the device forward and the upper esophageal sphincter opens to super-physiologic (greater than normal) proportions and allows food to pass. The procedure requires the patient to allow 8 weeks for the surgical site to heal and for the SED to integrate before attempting to use the device.

An FDA approved clinical trial

In June of 2014, the FDA approved a clinical trial ( Identifier: NCT02296528) – Safety and Efficacy of the Swallow Expansion Device (SED). This is a Phase I trial that is open to 5 patients with profound feeding tube dependent oropharyngeal dysphagia. The primary outcome measures are improvement in UES opening and swallowing safety as measured via fluoroscopy. If swallowing is improved and there is no aspiration, the patient will be taught how to coordinate pulling the SED with the correct amount of force at the appropriate time during swallowing. This training will be performed under the guidance of a speech and language pathologist.

There is some fascinating history behind this invention that is explained near the bottom of the clinical trial documentation. Click on NCT02296528 to read more about this trial on

Back to Jeff Mauerman

In early January 2015, Dr. Belafsky and his team at UC Davis placed the SED in Jeff Mauerman. It was done under a local anesthetic through a small 1.5 inch incision. The skin was lifted, the device inserted onto the cartilage, the post was pierced through the skin; the site was then sutured, cleaned, and bandaged. It took about 30 minutes start to finish.

I asked Jeff how he felt about being the “first” patient. He said there was a mixture of excitement at the prospect of being able to eat socially with the anxiety of being that first “trial” patient. The anxiety dissipated after a few days; now there is excitement tempered with the reality of, “will this really work? “ To find out, Jeff will need to wait the eight weeks from the time of the procedure to allow the site to heal properly and the device to integrate. After that there will be a prolonged training period for him to learn how to effectively use the device during meals. Jeff remains optimistic, but also realistic. In his own words, “if this works, I and my family are beyond fortunate; if it doesn’t, I haven’t lost anything.”

The NFOSD will report back on Jeff’s progress in April. Stay tuned!

Screen Shot 2015-06-12 at 3.10.25 PM


Ed Steger would like to thank both the Mauerman’s and Dr. Belafsky for their courage in sharing their story mid way through patient #1 in a small phase 1 clinical trial with an outcome that will not be known until the April 2015 time frame.

37 Comments On “Breaking news – A potential game changer for patients with profound oropharyngeal dysphagia

  1. Ashlee Sparrow Reply

    such an exciting trial and advancement for swallowing disorders. As a speech/language pathologist, I am very anxious to hear the results. Good luck all involved!!!!

  2. Barb Huether Reply

    This is very exciting. Might this procedure be applicable to someone with bilateral vocal cord paralysis/dysphagia?

  3. Gerard DeNapoli Reply

    My situation is exactly the same as Mr. Mauerman’s verbatim including time line. Will be anxious to hear how it works.

  4. Carol Saccomano Reply

    To Jeff,
    God Speed Brother in law.
    Hoping all goes well, keeping a positive attitude all goes well for Jeff!

  5. Leslie Mauerman Reply

    Fantastic article and ground breaking progress! Prayers for 100% success from your brother and another sister-in-law in San Diego.
    Leslie & Mark Mauerman

  6. Jane Solomon Reply

    Keeping you in my prayers Jeff.

  7. Kay Wood Reply

    To Jeff,
    Praying for you that this works for you. Since I also have Dsyphagia & a feeding tube, I understand the social dynamic as for me enjoying food with friends & family is now more important than the food itself.
    Looking forward to hearing your progress-very exciting!


    como fonoaudiologo estoy ansioso de ver estos resultados y de seguro que serán positivos, ya que seria de gran utilidad estos dispositivos y aliviarían a muchas personas con disfagia su temor a ahogarse.

    With Google translate…
    as speech therapist I am anxious to see these results and for sure will be positive, since it would be very useful these devices and alleviate many people with dysphagia his fear of drowning.

  9. Susan Durnell Reply

    This should be a boon for many survivors of head and neck cancers. I don’t have dysphagia at present, bur did after my radiation. I had, and still have multiple throat dilations, where Jeff seems to only have had the one. But I’m also only four + year out. So will be following this, as it might have something to do with my future.

  10. Susan Hamilton Reply

    You are such an inspiration! Thank you for being the first! I’m confident it will work, afterwall. .Peeps are waiting for you!


  11. Janice Goodman Reply

    Jeff and Patti,
    Best of luck to you both and you are in my prayers. I admire your courage and know your effort will eventually help improve the quality of life for so many people.

  12. Kim Grove Reply

    Joe and I are praying for a full and complete recovery for you! So excited to see you be this device’s first success story!

  13. Barbara Boliek Reply

    I have had extensive surgery on my neck and tongue and been on a feeding tube for 9 years. I have lost so much weight and cant put any on. If I put anything at all no matter how small in my mouth it goes in my lungs and I wind up in intensive care. I have been there 3 times but God pulled me through. I am even afraid to brush my teeth for fear it will go in my lungs. Its been 9 years since I have had food and guess I will never eat again.Barb Boliek

  14. Shirley Locke Reply

    Fascinating! Best wishes for complete success!

  15. Amelia Robinson Reply

    Sounds great! Hope it works! Just confused where the placement is? Obviously it’s not “on the voicebox”..does the large plate sit inside the UES? Voicing issues? Constant globus sensation from the implant? What of the primary deficit is tongue base retraction/vallecular residue and not UES opening/pyriform sinus residue/laryngeal elevation? I’m excited for anything that helps or patients 🙂

  16. Maria Goubran Reply

    I think this is fantastic news. My sister has had chronic dysphagia for nearly 6 years and has a peg tube for feeding. She has tried everything to get her swallowing back and so far nothing has worked. I wish Dr. Belafsky
    and Jeff success. I am glad you are both courageous and hope that this will lead to improved lives for sufferers of this socially isolating condition.

  17. Karen Propes Reply

    Good luck Jeff, you have endured so much, this would be a great miracle if it works. May God bless you and your family. Will be watching to see if it works.

  18. El Reply

    Sounds wonderful! Hope it works! Just confused where the placement is? Obviously it’s not “on the voicebox”..does the large plate sit inside the UES? Voicing issues? Constant globus sensation from the implant? What of the primary deficit is tongue base retraction/vallecular residue and not UES opening/pyriform sinus residue/laryngeal elevation? I’m excited for anything that helps or patients 🙂

    1. nfosdadmin Reply

      Please see reference…
      Laryngoscope. 2010 Apr;120 Suppl 1:S1-S16. doi: 10.1002/lary.20833.
      Manual control of the upper esophageal sphincter.
      Belafsky PC1.

  19. ADifrentMe Reply

    Im 18 and have been stuck with a feeding tube since i had a brain injury at 13. :,) this could be a new beginning for ppl like me.

  20. John Reply

    I wanted to mention I had a break through and can now eat after being on a feeding tube for eight months since having my epiglottis removed. A partial laryngectomy, The SLP had me lay on my side and I can swallow liquid and food without aspiration. I encourage you to try this maneuver as I never heard of it but it works for me. I cannot eat eat sitting up. But laying on my side works. I have since had the tube removed and I am eating most foods and liquids. I was told I would never eat or drink again without using the tube. So this simple maneuver has changed my life and I wanted to get the word out there. God bless all who suffer this problem.

    1. Dan Reply

      Hi John,
      My swallowing difficulties are due to epiglottis issues also. I’ve never heard of the laying on your side while eating so I have a few questions: which side do you lay on? Can you eat solid foods? Have you had any aspiration events since?

      Thanks in advance!

  21. Dennis R Huie Reply

    I, too, have dysphagia caused by being struck broadside by a deer while riding a small Honda scooter. I had the PEG for 7 months. SLP finally evaluated and approved me to return to eating. That was 3 yrs ago, and the problem has resurfaced. I would be willing to undergo the procedure, as I would love to have a piece of fried chicken, among other things I can’t eat.

  22. Sharon Keasler Reply

    This is fascinating. I have little tongue connection with the soft pallet and apparent inactive nerves as I can’t tell where the food is located on my tongue. It is more complicated than this but the result is aspiration and major breathing difficulty. Interested in stem cell possibilities or anything that will keep me from the peg tube.

  23. […] that daring youngsters might use to pierce their necks. Every time a user of Belafsky’s Swallo...
  24. SC Tan Reply

    This is exciting, it gives us hope to be able to eat and drink again. Hope all has been well so far for this new procedure. I hope to have a chance to go through this procedure one day and lead a normal life again.

  25. Brian Krause Reply

    I am 12 yrs out from Radiation and Chemo for tongue cancer. Two years ago developed Dysphagia. 100% tube feeding now..

    I am looking into this treatment…

  26. Howard Lewis Reply

    Good article, and a very promising development. Today is September 28, 2016, over 18 months after this article was published. Sorry, this is no longer “breaking news.” It’s time for a follow-up. How has the device worked?

    1. Ed Steger Reply

      Ed Steger wrote… Thank you Howard, that’s a good question. We appreciate you posting this reminder. I reached out to Jeff Mauerman today to ask for a brief update. As a refresher on Jeff’s oral intake prior to the SED device, please read the above article. Jeff was kind enough to reply and the following is a direct quote:

      “The SED is working quite well. It allows me to take my hydration orally without the need to supplement via the feeding tube. I am also able to eat breakfast orally if I have a thin porridge of something like “Cream of Wheat”. Anything thicker tends to get stuck and eventually will cause aspiration. As an aside, I did try some pudding several months back but ended up coughing because it would not flow down easily.”

      In the next few months, we’ll revisit this subject and provide a more comprehensive update.

  27. Rosa Lee McCurdy Reply

    I am 84 years old and was experiencing difficulty swallowing. After suffering with this for sometime I finally agreed to an endoscopy. During this procedure my esophagus was perforated and I was taken into emergency at a different hospital. I was put on IV with an antibiotic and kept on the IV for, as far as I can recall 2 days. The 3rd day I was allowed to have liquids. I was told that I would be transferred to another hospital the nest morning but instead I was released from the hospital simply being told they would keep in touch and advise me when I would be transferred. The transfer never took place but a referral to a digestive health specialist was made. I was not able to understand what they were really going to do other than another endoscopy; this I refused.
    I was able to swallow all liquids and some pureed foods and was able to live a pretty normal life but all that changed suddenly.
    As of this writing even water goes down very slowly and the ensure I have been on for quite sometimes goes down even slower. I really need help and I don’t what I am going to do. I am fearful of going back to a doctor.
    I am a veteran of the Korean War and a lifetime member of Disabled American Veterans and will enter the long waiting lines to see if the Veterans Hospital can do anything for me. I am reluctant to do this because I have excellent Medical coverage with United Health Care. But even that organization turns a deft ear to the fact that they ran t ct scans on me at an exorbitant cost and my emergency room bill I am refusing to pay because they kept me in the Emergency room for 4 hours because, presumably, their computers were down. Right now I am being handled like a hot potato by every medical person I encounter.

  28. Patti Domingo Reply

    I am so enlighten by these articles, research and trials with this new device. My son has the same thing having to go thru a 25 hours of surgery to remove 85% of his tongue at the Huntsman Cancer hospital. We are at the point of working on his swallowing which he cannot do and his nutrition which caused him to be now at 88 pounds. He can taste and smell but cannot swallow his food or liquid. He is being fed by a JG tube.
    I would like to know how we can be part of this trial or how we can get him to eat again.
    Right now he swishes his mouth because of his radiation that we are doing for another 3 weeks which is a total of 6. Although Utah has been good to us, we need to move forward to one day have David enjoy chewing and swallowing his food. Any questions to where we go from here?
    Thank you

    1. Member nfosdadmin Reply

      This work is an approved Phase 1 human trial currently recruiting patients. For more information on inclusion/exclusion criteria, the principal investigator, and other trial information, click on this link at

  29. Jacqueline Reply

    May God give you guidance to never give up on finding a way that people can eat again without a feeding tube.
    I have a husband who has identical issues as Jeff from radiation 17 years ago.
    ThAnk you for trying.

  30. Christine Reply

    Hello. I am wandering how Jeff is doing nearly three years after the operation. Has it been successful in the fact that he is able to eat and drink again? Could you please give an update. Thank you very much. Christine

    1. Member nfosdadmin Reply

      Hi – Thank you for your inquiry. We are staying in touch with the clinical trial’s principal investigator. He plans to wait until additional patients are treated such that he can provide a more comprehensive assessment and report. We too are interested and will provide an update when available. – The NFOSD Team

  31. Gayle Schneider Reply

    I am praying that this has a great outcome. I am helping my sister deal with her husband that has back of the tongue cancer and can not swallow his own spit and can not drink. Advances like this are wonderful and give hope to people with this ailment.
    I look forward to hearing more about this.

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