Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Eustachian Tube Dysfunction (ETD)

Treatment: coverage for balloon dilation of the eustachian tube

The insurer denied coverage for balloon dilation of the eustachian tube.

The denial is overturned.

This is the case of an adult female with bilateral otalgia and tinnitus, for many years, and experiences popping of ears bilaterally. She has been diagnosed with eustachian tube dysfunction (ETD) and has failed multiple trials of nasal steroids, oral steroids, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), bilateral myringotomy and tubes (BMT) placement. She has had flat tympanograms.

The Otolaryngology-Head and Neck Surgery (OTO-HNS) policy statement on ETD supports the balloon dilation of eustachian tube use when defined criteria are met, which this patient fulfills.

"The US (United States) Food and Drug Administration (FDA) approved marketing of a device that uses an endoscopically directed balloon to treat persistent obstructive eustachian tube dysfunction (OETD). This approval followed a randomized, controlled, clinical trial that compared results at 6 weeks in patients who underwent balloon dilation of the eustachian tuboplasty (BDET) plus medical therapy (corticosteroid nasal spray) with those patients who had medical therapy only, with superior outcomes observed after BDET compared with medical management." (Tucci, D. L. et al.)     

This patient was a good candidate for the balloon dilation of eustachian tube. The OTO-HNS policy statement on ETD supports its use when defined criteria are met, which this patient fulfills.

"Eustachian tube dysfunction (ETD) is the failure of the Eustachian tube in maintaining pressure equalization or mucociliary transport. This is categorized as either acute (less than 3 months presentation) or chronic ETD (more than 3 months). ETD affects 1% (percent) of the population, with symptoms including aural fullness or 'popping sounds,' reduced hearing, tinnitus, autophony, otalgia, and imbalance. It can be broadly categorized into baro-challenged induced, patulous, and dilatory ETD..."     

This patient has failed medical management of her ETD, which is causing pain and tinnitus, and exacerbating her vertigo. The next level of treatment is surgical with balloon dilation, therefore, the balloon dilation of eustachian tube was the best available treatment for this patient at that time.     

She has failed medical management of her ETD which is causing pain/tinnitus and exacerbating her vertigo. The next level of treatment is surgical with balloon dilation. The patient meets the criteria outlined by the OTO-HNS in their policy statement.

Stated by Siow, J. K., & Tan, J. L., "In the past 10 years, balloon dilation Eustachian tuboplasty (BDET) has been the most commonly performed Eustachian tube dilation procedure...

Eustachian tube balloon dilation appears to be associated with improvement in subjective and objective treatment outcome metrics. The improvement appears stable at 3 to 12 months after dilation. Patients with eustachian tube dysfunction are likely to benefit from balloon dilation, particularly those with medication-refractory disease." 
The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome from balloon dilation of eustachian tubes. This patient failed medical management of her ETD, which was causing pain/tinnitus, and exacerbating her vertigo. The next level of treatment would be surgical with balloon dilation.  

This procedure is FDA approved. It appears that this patient is a good patient for this device. The procedure is likely to be more beneficial than standard treatment which has not been successful in this patient. The risks are not substantially increased over standard treatment services. The procedure should not be considered experimental/investigational.                         

The carrier's denial of the balloon dilation of eustachian tube should be overturned.