Why Is Eustachian Tube Balloon Dilation to Treat Eustachian Tube Dysfunction Slow to Catch On?

Eustachian tube dysfunction is a phenomenon whereby a person is unable to pop their ears to relieve symptoms of ear pressure, clogging, or fullness. It is much akin to the ear pressure a person experiences when flying, but at ground level. Traditionally, treatment of this condition involved medications like steroid nasal sprays and prednisone along with active valsalva (watch video below). Once medical treatment has failed, ear tube placement has been the step of last resort.

However, a promising new treatment called eustachian tube balloon dilation has been described in March 2011 to address eustachian tube dysfunction at the source (the eustachian tube) surgically rather than indirectly with tube placement across the eardrum. In essence, a balloon is inserted into the eustachian tube and than inflated thereby opening it up (the balloon is "popping" the ear for you). The balloon is than deflated and removed.

Dr. Dennis Poe in Boston, MA is the researcher who first described this technique in March 2011 and at this time, is offered only in a few centers.

Why has something so simple with equipment so readily available been so slow to gain acceptance by ENTs?

Well, there are several reasons, not the least of which is the fact that this procedure is still considered "experimental" and in the research stage only.


However, there is the cost of the balloon itself which is typically not covered by insurance even if a patient wishes to proceed with an unproven treatment. The material cost of the balloon is around $2000 or more. Compare this to the cost of a tube which is around $30 or less. In other words, hospitals would lose money by offering this procedure with current fee schedules.

Furthermore, there are potentially huge, albeit rare risks associated with balloon dilation of the eustachian tube. These risks are clearly reported by Dr. Dennis Poe who "invented" this procedure in his landmark paper.

The internal carotid artery supplies blood to the brain and can be found right next to the eustachian tube. Take a look at this CT scan of the ear:

ET is the eustachian tube and CA is the carotid artery (EC is the ear canal). These structures are found right next to each other!

The balloon catheters used for eustachian tube dilation have a fairly pointy tip (though not sharp), but when placed in a directed fashion inside of small diameter tunnel like the eustachian tube, there is the chance that the catheter tip may puncture or injure the carotid artery leading to risk of:

1) horrible bleeding
2) stroke
3) arterial wall dissection or aneurysm formation
4) death

In most individuals, there is a thin layer of bone that separates the carotid artery from the eustachian tube that does proffer some protection. But, this bone is not always present and therefore can not be counted on to protect the artery from any unintentional injury.

It is also possible that with balloon dilation, the bone separating the artery from the eustachian tube can fracture resulting in constant crunching sounds with jaw movement due to the bone fragments rubbing against each other.


So to summarize, given ear tube placement has profoundly less risk, much cheaper, and long history of effectiveness compared to balloon dilation of the eustachian tube which has significant risks, expensive, and unproven long-term results, it is actually no wonder that the balloon method has been slow to gain acceptance.

Indeed, in another published article, it specifically states balloon sinuplasty to be a "gizmo" of uncertain safety and efficacy... in fact, the title of the article says it all "Balloon Dilation of the Eustachian Tube Is Indeed a 'Gizmo' Until Future Research Proves Safety and Efficacy."

In another paper, they stated that:

"The evidence of balloon eustachian tuboplasty is poor and biased. No firm conclusions can be made to identify patients who will benefit from the procedure or to accurately predict surgical results. Randomized controlled trials or case-control trials are needed."

Addendum 9/21/16:
On Sept 16, 2016, the FDA approved the technology to perform eustachian balloon tuboplasty. Manufactured by Acclarent, the Aera Eustachian Tube Balloon Dilation System has been approved for patients older than 22 years old, lack of bone dehiscence exposing the carotid artery, and absence of patulous eustachian tube dysfunction. Of course, FDA approval does NOT mean insurance coverage which may take a few years. [More Info]

Reference:
Balloon Dilation of the Cartilaginous Eustachian Tube. Otolaryngol Head Neck Surg April 2011 vol. 144 no. 4 563-569

Balloon catheter dilatation of eustachian tube: a preliminary study. Otol Neurotol. 2012 Dec;33(9):1549-52. doi: 10.1097/MAO.0b013e31826a50c3.

Balloon Dilation of the Eustachian Tube Is Indeed a "Gizmo" Until Future Research Proves Safety and Efficacy.Otolaryngol Head Neck Surg. 2014 Jun 3. pii: 0194599814538232.

Balloon Dilation of the Cartilaginous Portion of the Eustachian Tube. Otolaryngol Head Neck Surg. 2014 Apr 4;151(1):125-130. [Epub ahead of print]

Balloon Eustachian Tuboplasty: A Systematic Review. Otolaryngol Head Neck Surg. 2015 Jan 20. pii: 0194599814567105. [Epub ahead of print]

Balloon dilation for eustachian tube dysfunction: systematic review. J Laryngol Otol. 2016 Jul;130 Suppl 4:S2-6. doi: 10.1017/S0022215116008252.



Some Products that Help with Eustachian Tube Dysfunction: