To systematically identify the complications associated with balloon Eustachian tuboplasty and their frequency of occurrence. This study will also highlight the measures that can be employed to avoid these complications and perform this procedure more safely.

Systematically reviewed relevant papers published until January 2023. Each reference was checked and evaluated for any potential manuscripts. There was no registered protocol; the Preferred Reporting Items for Systematic Reviews and Meta-Analyses was used.

Sixty-nine publications were found, from which 14 publications met our inclusion criteria: 2 randomised clinical trials, 5 retrospective studies, 2 systematic reviews, 2 case series and 3 case reports. Studies with balloon Eustachian tuboplasty procedure only were included, regardless of ethnicity, gender and age. All studies were excluded in which more than one procedure was performed.

Balloon Eustachian tuboplasty is a relatively safe procedure with an overall complication risk of 1.66 per cent. Major complication rate was 0.43 per cent. Surgical emphysema was the most common, around 0.40 per cent.