Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Ear/Nose/Throat
Treatment: Surgical Services - Balloon dilatation Eustachian Tuboplasty
The insurer denied Balloon dilatation Eustachian Tuboplasty. 
The denial is upheld. 

This patient is a female with complaints of right otalgia, hearing loss and left Eustachian tube dysfunction. She reported undergoing multiple myringotomies with tubes and that her right tube extruded, leaving a perforated tympanic membrane and a right conductive hearing loss. Balloon Eustachian tube dilations were recommended.

At issue is whether the Balloon dilatation Eustachian Tuboplasty is likely to be more beneficial than any standard treatment or treatments.

The health plan's determination regarding the proposed health service or treatment is upheld in whole.

The proposed health treatment Balloon dilatation Eustachian Tuboplasty is not likely to be more beneficial than any standard treatment or treatments for the insured's disease.
Currently the evidence-based literature does not allow for any conclusive conclusions regarding efficacy, effectiveness, or safety of these devices (Hayes). In a prospective, multicenter, randomized, controlled trial, Poe, et al assessed balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dysfunction. Patients aged 22 years and older were assigned in a ratio of 2:1 and underwent balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. The conclusions demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter plus medical management compared to medical management alone. A limitation of the study was the small sample size utilized.

Hwang, et al performed a meta-analysis examining balloon dilatation and laser tuboplasty for the treatment of eustachian tube dysfunction (ETD). Pub Med, Cochrane and Embase databases were searched with the following results: 2 retrospective and 11 prospective studies which resulted in 1063 patients - 942 treated with balloon dilation and 121 with laser tuboplasty. Balloon tuboplasty resulted in a significant improvement of eustachian tube scores and compared with laser tuboplasty, a greater tympanometry improvement rate. It was concluded that both procedures can improve symptoms of ETD; however, because of the limited numbers of studies reporting data it remains unclear if one procedure provides greater benefits in a prospective, multicenter, randomized, controlled trial. Micucci, et al, in a review of the literature concluded that eustachian tube balloon dilation (ETBD) is a novel technique for the treatment of chronic eustachian tube dysfunction (ETD), and its role continues to evolve and develop with current practice patterns demonstrating wide variability in the assessment of ETD, heterogeneity in the timing of ETBD and controversy in preoperative screening.

Based upon the clinical and the evidence-based literature, the proposed treatment, Balloon Eustachian Tuboplasty, is not likely to be more beneficial than any standard treatment or treatments for the insured's disease.