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.

Click here to watch a video of this procedure. More info can be found here.

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" by most insurance companies, though that may change in the near future given that this procedure has recently obtained FDA approval (September 16, 2016).


There is also cost considerations. The material cost of the balloon is around $1000 or more. Compare this to the cost of a tube which is around $30 or less.

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 historically contained 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

Other risks include subcutaneous emphysema, patulous eustachian tube, nasopharyngeal mucocele, and tinnitus [more info]. 

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.

In order to minimize these risks (though the risk is still not ZERO), a CT scan is required to ensure the presence of bone to protect the carotid artery.

Also, advances have been made in the balloon itself to minimize these risks, mainly by making the balloon tip less pointy and sharp as well as making the balloon itself much more flexible. Acclarent has such a balloon called Aera Eustachian Tube Balloon Dilation System that is specifically made for use in the eustachian tube.

Keep in mind that with balloon dilation, it is possible that 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 potentially significant risks, expensive, and unproven long-term results, it is actually no wonder that the balloon method has been slow to gain acceptance though it has been increasing.

Even in expert hands, success rates are only about 60% in resolving ear symptoms 6 months after surgery. [link]

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."

However, there is enough supporting evidence being published that this procedure is a viable option to consider for those who are candidates with about 60% success rates. In fact, our office is considering offering this procedure at some point in the near future. Appropriate candidates include those older than 22 years old, lack of bone dehiscence exposing the carotid artery based on CT scan, absence of patulous eustachian tube dysfunction, along with both exam and test findings supportive of 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 eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. 2017 Sep 20. doi: 10.1002/lary.26827. [Epub ahead of print]

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.

Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube. Otolaryngol Head Neck Surg. 2019 Jun 4:194599819848423. doi: 10.1177/0194599819848423. [Epub ahead of print] 

 
Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation. Oto Open Volume7, Issue3 July–September 2023 e70.