Hostname: page-component-6565fbc58-wqvqn Total loading time: 0 Render date: 2026-03-11T10:07:16.847Z Has data issue: false hasContentIssue false

Eustachian tube balloon dilation for middle ear effusion in children with cleft lip and palate

Published online by Cambridge University Press:  11 December 2025

Samuel Abishegam
Affiliation:
Department of Otorhinolaryngology, Faculty of Medicine, Universiti Malaya, Jalan Universiti, Kuala Lumpur, Malaysia
Jeyasakthy Saniasiaya*
Affiliation:
Department of Otorhinolaryngology, Faculty of Medicine, Universiti Malaya, Jalan Universiti, Kuala Lumpur, Malaysia
Jeyanthi Kulasegarah
Affiliation:
Department of Otorhinolaryngology, Faculty of Medicine, Universiti Malaya, Jalan Universiti, Kuala Lumpur, Malaysia
*
Corresponding author: Jeyasakthy Saniasiaya; Email: shakthy_18@yahoo.com

Abstract

Problem

Eustachian tube balloon dilation is increasingly recognised as a minimally invasive option for middle ear effusion. However, its role in children with cleft lip and palate remains under-explored.

Methods

We prospectively evaluated 14 cleft lip and palate children (28 ears) with middle ear effusion. Group 1 (intervention) comprised 14 ears that underwent Eustachian tube balloon dilation with intranasal corticosteroids, while Group 2 (control) included 14 ears treated with intranasal corticosteroids alone. Tympanometry, pure-tone audiometry and Eustachian Tube Dysfunction Questionnaire-7 were administered before and six weeks after intervention.

Results

Eustachian tube balloon dilation significantly improved hearing thresholds (p = 0.03) and air-bone gap (p = 0.04), with favourable tympanometric changes (p < 0.05) and a significant reduction in Eustachian Tube Dysfunction Questionnaire-7 scores, indicating symptom improvement. No major complications occurred.

Conclusion

Eustachian tube balloon dilation is a safe, well-tolerated and potentially effective adjunctive procedure for cleft lip and palate children with middle ear effusion. Larger randomised controlled trials are needed to validate these findings.

Information

Type
Main Article
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of J.L.O. (1984) LIMITED.

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

Footnotes

Jeyasakthy Saniasiayatakes responsibility for the integrity of the content of the paper

References

Rosenfeld, RM, Shin, JJ, Schwartz, SR, Coggins, R, Gagnon, L, Hackell, JM, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg 2016;154:S141Google ScholarPubMed
National Institute for Health and Care Excellence (NICE). Surgical Management of Otitis Media with Effusion in Children. London: RCOG Press; 2008Google Scholar
SFORL. Prise en charge thérapeutique des OSM de l’enfant | Recommandations de pratiques cliniques. In: http://www.orlfrance.org/download.php?id=319 [11 December 2025]Google Scholar
Simon, F, Haggard, M, Rosenfeld, RM, Jia, H, Peer, S, Calmels, M-N, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis 2018;135:S339CrossRefGoogle ScholarPubMed
Ponduri, S, Bradley, R, Ellis, PE, Brookes, ST, Sandy, JR, Ness, AR. The management of otitis media with early routine insertion of grommets in children with cleft palate- a systematic review. Cleft Palate Craniofac J 2009;46:30–8CrossRefGoogle ScholarPubMed
Bruce, I, Harman, N, Williamson, P, Tierney, S, Callery, P, Mohiuddin, S, et al. The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation. Health Technol Assess 2015;19:1374CrossRefGoogle Scholar
Maheshwar, AA, Milling, MAP, Kumar, M, Clayton, MI, Thomas, A. Use of hearing aids in the management of children with cleft palate. Int J Pediatr Otorhinolaryngol 2002;66:5562CrossRefGoogle ScholarPubMed
Civelek, B, Çelebioğlu, S, Sağit, M, Akin, I. Ventilation tubes in secretory otitis media associated with cleft palate: a retrospective analysis. Turk J Med Sci 2007;37:223–6Google Scholar
Saniasiaya, J, Kulasegarah, J, Narayanan, P. Outcome of eustachian tube balloon dilation in children: a systematic review. Ann Otol Rhinol Laryngol 2022;131:797804CrossRefGoogle ScholarPubMed
McCoul, ED, Anand, VK, Christos, PJ. Validating the clinical assessment of eustachian tube dysfunction: the Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope 2012;122:1137–41CrossRefGoogle ScholarPubMed
Julious, SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005;4:287–91CrossRefGoogle Scholar
Flynn, T, Möller, C, Jönsson, R, Lohmander, A. The high prevalence of otitis media with effusion in children with cleft lip and palate as compared to children without clefts. Int J Pediatr Otorhinolaryngol 2009;73:1441–6CrossRefGoogle ScholarPubMed
Fitzsimons, KJ, Copley, LP, Van Der Meulen, JH, Panagamuwa, C, Deacon, SA. Grommet surgery in children with orofacial clefts in England. Cleft Palate Craniofac J 2017;54:80–9CrossRefGoogle ScholarPubMed
Yaman, H, Yilmaz, S, Alkan, N, Subasi, B, Guclu, E, Ozturk, O. Shepard grommet tympanostomy tube complications in children with chronic otitis media with effusion. Eur Arch Otorhinolaryngol 2010;267:1221–4CrossRefGoogle ScholarPubMed
Howard, A, Babu, S, Haupert, M, Thottam, PJ. Balloon eustachian tuboplasty in pediatric patients: is it safe? Laryngoscope 2021;131:1657–62CrossRefGoogle ScholarPubMed
Ockermann, T, Reineke, U, Upile, T, Ebmeyer, J, Sudhoff, HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope 2010;120:1411–6CrossRefGoogle ScholarPubMed
Toivonen, J, Kawai, K, Gurberg, J, Poe, D. Balloon dilation for obstructive eustachian tube dysfunction in children. Otol Neurotol 2021;42:566–72CrossRefGoogle ScholarPubMed
Maier, S, Tisch, M, Maier, H. Ballon dilation of the Eustachian tube in a pediatric chronic obstructive Eustachian tube dysfunction patients. HNO 2015;10:686–97CrossRefGoogle Scholar
Leichtle, A, Hollfelder, D, Wollenberg, B, Bruchhage, KL. Balloon Eustachian tuboplasty in children. Eur Arch Otorhinolaryngol 2017;274:2411–19CrossRefGoogle ScholarPubMed
Gürtler, N, Husner, A, Flurin, H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol 2015;36:437–43CrossRefGoogle ScholarPubMed
Gürtler, N, Honegger, F. Eustachian tube balloon dilation in children: short- and long-term outcome. Ann Otol Rhinol Laryngol 2024;133:369–74CrossRefGoogle ScholarPubMed