Eustachian Tube Balloon Dilation in Children: Prospective Clinical Outcomes of a Low-Cost Endovascular Balloon

OBJECTIVE: Balloon dilation of the Eustachian tube (BDET) is increasingly used to treat pediatric obstructive Eustachian tube dysfunction (OETD); however, its broader adoption is limited by the cost of commercially available devices. Standard endovascular balloons may offer a cost-effective alternative, but pediatric outcome data are limited. This study evaluated the feasibility, safety, and early clinical outcomes of pediatric BDET performed using standard endovascular balloon catheters. METHODS: This prospective clinical study included 14 pediatric patients (≥5.5 y) with bilateral OETD (28 ears) who remained symptomatic despite optimized medical therapy and prior standard surgical interventions. All patients underwent endoscopic BDET using standard endovascular balloon catheters. Outcome measures included symptom severity assessed by the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), otoscopic findings, tympanometric classification, pure-tone audiometry, and functional Eustachian tube assessment using the Valsalva maneuver. Analyses accounted for bilateral observations using mixed-effects and generalized estimating equation models. Procedural feasibility and complications were recorded. RESULTS: Fourteen patients (28 ears; mean age 11.3 ± 3.6 y) were analyzed. On the basis of predefined success criteria incorporating symptom improvement, audiological outcomes, functional assessment, and otoscopic findings, the overall success rate was 75%. Linear mixed-effects modeling demonstrated significant improvement in ETDQ-7 scores (mean reduction: -1.921; P < 0.001) and pure-tone average (mean improvement: -15.243 dB; P < 0.001). Generalized estimating equation analysis showed significant improvement in otoscopic findings (OR: 0.030; P < 0.001), tympanometric status (OR: 0.101; P = 0.001), and dynamic endoscopic grade (OR: 0.010; P < 0.001). A positive Valsalva maneuver was achieved in 71.4% of ears ( P < 0.001). No complications occurred in 89.3% of ears; adverse events were minor and self-limited, with no major complications observed. CONCLUSIONS: Pediatric BDET using a standard endovascular balloon catheter seems feasible and safe in children with obstructive Eustachian tube dysfunction refractory to conventional management. Early outcomes are comparable to those reported for commercially available systems, supporting the potential role of a lower-cost balloon alternative in appropriately selected pediatric patients. Further controlled studies are warranted to confirm long-term safety and durability of outcomes.