Background: Balloon Eustachian Tuboplasty (BET) is a minimally invasive treatment option for patients with chronic tube dysfunction which involves passing a balloon catheter into the Eustachian tube (ET). By temporarily dilating the ET with the balloon, its clearance and ventilator function is to be re-established and symptoms of chronic tube dysfunction are to be improved. Potential consequences of chronic tube dysfunction are acute or chronic otitis media, damage to the middle ear and eardrum and hearing loss. Tube dysfunction has a prevalence of approx. 1% in adults. Currently, there are 2 CE marked products on the market for BET: the Bielefelder Ballonkatheter/TubaVent® produced by Spiggle & Theis and the AERATM produced by Acclarent Inc./Johnson & Johnson. This report, which is based on a EUnetHTA assessment published in February 2015, aims to compare the effectiveness and safety of BET in patients aged >12 years with tympanostomy and medication.

Methods: This report is based on a joint European assessment systematically evaluating the effectiveness and safety of the intervention, and includes a literature update from August 2015. Results from the European systematic review were summarised in German and completed with results from the update.

Results: Eight case series with 1,046 patients overall were included in the assessment of effectiveness and safety of BET; no comparative studies were identified. The evidence shows a normalisation of post-operative tympanogram results in 28% to 97% of patients. 45% to 80% of patients were able to do the Valsalva manoeuvre post-operatively; 66% of patients reported subjective improvements. Symptom improvements and an improvement of quality of life measures were also demonstrated. There is long term evidence that symptoms of Eustachian tube dysfunction can be improved by BET. Minor adverse events include bleeding in the nasopharyngeal area (1.4% - 4.8%), 4 cases of otitis media (8%), rhinitis-like symptoms (47.6%) and subcutaneous emphysema in the facial area (1.4%). One major adverse event, a mediastinal emphysema, occurred in one of the studies.

Conclusion: Due to a lack of comparative data, no definite conclusions can be drawn as to whether BET is effective and safe in the treatment of Eustachian tube dysfunction.