Background: Chronic serous otitis media associated with Eustachian tube dysfunction (ETD) is commonly managed with long-term ventilation tube (grommet) insertion. Balloon Eustachian tuboplasty (BET) has emerged as a novel therapeutic option aimed at improving Eustachian tube function. This study compares the outcomes of BET alone versus BET combined with grommet insertion in patients with chronic serous otitis media and ETD. Aim and Objectives: To evaluate and compare the effectiveness of Balloon Eustachian Tuboplasty (BET) alone and BET combined with grommet insertion in patients with chronic serous otitis media associated with Eustachian tube dysfunction (OME-ETD). Methods: This prospective comparative study included 72 patients with OME-ETD treated between October 2024 and November 2025. Patients were divided into two groups: BET group (n = 36) and BET + Grommet group (n = 36). Postoperative outcomes assessed at 6 and 12 months included air-bone gap (ABG), Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7), Eustachian tube inflammation scale, Chronic Otitis Media Outcome Test-15 (COMOT-15), Valsalva maneuver results, and patient satisfaction. Results: Postoperative ABG improvement was significantly greater in the BET + Grommet group compared to the BET group at both 6 and 12 months. The ETDQ-7, Eustachian tube inflammation scale, and COMOT-15 scores showed a significant reduction in the BET + Grommet group at follow-up intervals. The proportion of patients able to perform a positive Valsalva maneuver was significantly higher in the BET + Grommet group at both 6 and 12 months. Overall patient satisfaction was also superior in the combination therapy group. Conclusion: Balloon Eustachian Tuboplasty combined with grommet insertion demonstrates superior efficacy compared to BET alone in patients with OME-ETD. The combined approach results in better hearing outcomes, improved Eustachian tube function, reduced inflammation, and enhanced quality of life
Refractory otitis media with effusion (OME) is defined as persistent middle ear effusion despite repeated medical management and multiple ventilation tube (grommet) insertions [1]. OME is common in the pediatric population, with an incidence of up to 90% before school age, whereas its prevalence in adults is relatively low, estimated at approximately 0.6% [2]. Although most children with OME experience spontaneous resolution within three months, approximately 5–10% develop recurrent or persistent disease lasting one year or longer [3].
The pathogenesis of OME is multifactorial, with Eustachian tube dysfunction (ETD) playing a central role. Other contributing factors include acute otitis media, craniofacial anomalies such as Down syndrome and cleft palate, subclinical bacterial infection, and gastroesophageal reflux disease [2]. Long-term grommet insertion remains the conventional treatment for refractory OME [4]. However, repeated ventilation tube insertion does not address the underlying ETD and is often unsuccessful in preventing recurrence. Moreover, it may lead to complications such as tympanic membrane perforation, infection, and tympanosclerosis [5]. Persistent symptoms—including hearing loss, aural fullness, otalgia, tinnitus, and a sensation of pressure or popping in the ears—significantly impair patients’ quality of life [2–4].
ETD contributes to recurrent or persistent middle ear disease by impairing pressure regulation and aeration of the middle ear. While tympanostomy tube insertion temporarily ventilates the middle ear, it does not restore normal Eustachian tube function and may be associated with procedure-related complications [5]. Consequently, balloon Eustachian tuboplasty (BET) has emerged as a novel therapeutic approach targeting the underlying pathophysiology of ETD. First introduced into clinical practice in 2010, BET has been shown to be a safe and effective treatment for ETD, with superior postoperative outcomes compared to conventional medical therapies such as nasal steroids, decongestants, antihistamines, and tympanostomy tube placement alone [6,7].
Hearing impairment secondary to OME negatively affects speech and language development, educational achievement, employment opportunities, and psychosocial well-being, particularly in children [8].
ETD has been identified as a critical contributing factor in OME by disrupting middle ear ventilation and pressure equilibration. Studies have reported evidence of ETD in up to 70% of patients undergoing middle ear surgery [13]. Therefore, identifying effective therapeutic strategies for patients with OME combined with ETD (OME-ETD) is both urgent and clinically important.
BET has been proposed as a second-line treatment for ETD in cases where adenoidectomy and paracentesis have failed [13,14]. It has also been increasingly applied as an adjunctive surgical approach in the management of otitis media [16]. However, BET alone has demonstrated variable efficacy, with reported symptom improvement rates of approximately 66% [17]. Previous studies have shown that simultaneous BET and hearing reconstruction surgery can significantly improve hearing outcomes and Eustachian tube function in patients with OME-ETD [18]. Furthermore, BET has been suggested as a useful adjunct in the treatment of OME associated with obstructive Eustachian tube dysfunction [19].
Grommet insertion remains one of the most commonly performed surgical procedures for otitis media [20,21]. Nevertheless, it does not correct underlying ETD and is associated with complications such as infection, persistent tympanic membrane perforation, and tympanosclerosis [22]. Emerging evidence suggests that combining BET with grommet insertion may reduce complication rates and improve outcomes in patients with chronic Eustachian tube dysfunction [23].
Therefore, the present study was conducted to evaluate the combined effectiveness of balloon Eustachian tuboplasty and grommet insertion in patients with OME-ETD. Outcomes were assessed in terms of hearing improvement, Eustachian tube function, Eustachian tube inflammation, quality of life, and overall patient satisfaction.
A total of 144 ears from 72 patients diagnosed with Otitis Media with Effusion associated with Eustachian tube dysfunction (OME-ETD) were included in this study. Patients were evaluated between October 2024 and November 2025. The age of the participants ranged from 20 to 60 years. The subjects were divided into two groups: 36 patients underwent balloon Eustachian tuboplasty alone (BET group), and 36 patients underwent balloon Eustachian tuboplasty combined with grommet insertion (BET + Grommet group).
All enrolled patients fulfilled the following inclusion criteria:
Exclusion criteria included:
All patients underwent balloon Eustachian tuboplasty under general anesthesia. A balloon catheter measuring 20 mm in length and 3 mm in diameter was introduced endoscopically through the nasal cavity into the cartilaginous portion of the Eustachian tube. The balloon was inflated with distilled water to a pressure of 10 bar and maintained for 2 minutes. In the BET + Grommet group, patients additionally underwent ventilation tube (grommet) insertion into the tympanic membrane. All patients were followed up for a period of 12 months.
Pure-tone audiometry was performed using a Madsen OB922 audiometer (Otometrics, Taastrup, Denmark). Air- and bone-conduction thresholds were measured at frequencies of 500 Hz, 1 kHz, 2 kHz, and 4 kHz. The air–bone gap (ABG) was calculated as the mean difference between air- and bone-conduction thresholds. Surgical success was defined as a postoperative ABG of ≤20 dB [26].
Disease-specific quality of life was assessed using the Chronic Otitis Media Outcome Test-15 (COMOT-15), which has a total score ranging from 0 to 100 [27]. The questionnaire consists of three subscales: ear symptoms, hearing function, and mental health, along with two additional questions assessing the overall impact of OME on quality of life and the frequency of doctor visits related to OME during the previous six months. Higher COMOT-15 scores indicate poorer quality of life.
Eustachian tube inflammation was evaluated using nasal endoscopy. The degree of inflammation of the mucosa at the nasopharyngeal orifice and within the Eustachian tube lumen was graded from normal to severely inflamed (Grade 1–4), according to previously published criteria [28].
A positive Valsalva maneuver was defined as the patient perceiving a characteristic “pop” sensation or sound in the ear during the maneuver. Patient satisfaction was assessed at 6 and 12 months postoperatively and categorized as either satisfied or dissatisfied with the surgical outcome [29].
Statistical analysis was performed using SPSS Statistics software. Continuous variables were expressed as mean ± standard deviation, while categorical variables were presented as frequencies and percentages. The Student’s t-test was used to compare continuous variables between groups, and the paired t-test was applied to compare preoperative and postoperative outcomes within groups. Categorical variables were compared using the chi-square (χ²) test. All statistical tests were two-sided, and a P value <0.05 was considered statistically significant
The baseline demographic and clinical characteristics of patients in the BET group and BET + Grommet group were comparable. Detailed patient characteristics are summarized in Table 1.
Table 1: Evaluation of Eustachian tube function using the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7).
|
Symptom |
No problem |
Moderate problem |
Severe problem
|
|
Pressure in the ears? |
|
|
|
|
Pain in the ears |
|
|
|
|
A feeling that your ears are clogged? |
|
|
|
|
Ear symptoms when you have a cold or sinusitis? |
1∼2
|
3∼5
|
6∼7
|
|
Cracking or popping sounds in the ears? |
|
|
|
|
Ringing in the ears? |
|
|
|
|
A feeling that your hearing is muffled? |
|
|
|
|
Patients with ETD |
|
|
|
ETDQ-7 total score of 14.5 (mean item score 2.1)
Table 2: Demographic characteristics of OME-ETD patients in the BET group and BET + Grommet group.
|
|
BET group |
BET + Grommet group |
P-value |
|
|
Age (years) |
42.3±9.9 |
39.5±11.1 |
0.263 |
|
|
Gender |
Male |
20 |
17 |
0.477 |
|
Female |
16 |
19 |
0.477 |
|
|
Ear |
Right |
15 |
19 |
0.347 |
|
Left |
21 |
17 |
0.347 |
|
The demographic characteristics of patients with OME-ETD in the BET group and the BET + Grommet group are summarized in Table 2. There were no statistically significant differences between the two groups with respect to age (42.3 ± 9.9 years in the BET group vs. 39.5 ± 11.1 years in the BET + Grommet group; P = 0.263), gender distribution (P = 0.477), or laterality of the affected ear (P = 0.347), indicating that the two groups were comparable at baseline.
The preoperative and postoperative air–bone gap (ABG) values of OME-ETD patients in both groups are presented in Table 3. Comparative analysis was performed to evaluate hearing improvement following surgery in the BET group and the BET + Grommet group.
Table 3: Preoperative and postoperative air–bone gap (ABG) values in OME-ETD patients in the BET group and BET + Grommet group.
|
Groups |
Preoperative |
Postoperative |
|
|
6 months |
12 months |
||
|
BET group |
23.9±5.2 |
23.3±4.5 |
22.7±3.7 |
|
BET + Grommet group |
25.2±4.6 |
19.02±3.6 |
15.7±3.5 |
|
P-value |
0.265 |
0.0001 |
0.0001 |
Note: ∗P < 0.05, the intra group comparison with preoperative data.
Postoperative air–bone gap (ABG) and hearing improvement were evaluated in both groups at 6 and 12 months following surgery (Table 3, Figure 1). The mean preoperative ABG was 23.9 ± 5.2 dB in the BET group and 25.2 ± 4.6 dB in the BET + Grommet group, with no statistically significant difference between the groups (P = 0.265).
At 6 months postoperatively, the mean ABG in the BET + Grommet group (19.0 ± 3.6 dB) was significantly lower than that in the BET group (23.3 ± 10.6 dB; P < 0.05). This difference remained statistically significant at 12 months, with mean ABG values of 15.7 ± 3.5 dB in the BET + Grommet group compared with 22.7 ± 3.7 dB in the BET group (P < 0.05). Within-group analysis demonstrated a significant reduction in ABG at both 6 and 12 months in the BET + Grommet group (both P < 0.05).
A postoperative ABG of ≤20 dB was achieved in 42.2% of patients at 6 months and 44.4% at 12 months in the BET group. In contrast, 53.3% of patients at 6 months and 67.8% at 12 months in the BET + Grommet group achieved an ABG ≤20 dB, indicating superior hearing outcomes with the combined treatment approach.
Table 4: Improvement in ETDQ-7 score, Eustachian tube inflammation scale, and COMOT-15 following treatment with balloon Eustachian tuboplasty combined with grommet insertion.
|
Groups |
Preoperative |
Postoperative |
|
||
|
6 months |
12 months |
|
|||
|
ETDQ-7 scores |
BET group |
26.7±4.5 |
24.9±5.6 |
23.1±4.2 |
|
|
BET + Grommet group |
27.3±4.8 |
21.1±4.1 |
18.7±3.6 |
||
|
P-value |
0.586 |
0.002 |
0.0001 |
||
|
Eustachian tube inflammation scale |
BET group |
3.05±0.7 |
2.7±0.6 |
2.1±0.6 |
|
|
BET + Grommet group |
2.9±0.7 |
1.96±0.6 |
1.5±0.5 |
||
|
P-value |
0.366 |
0.0001 |
0.0001 |
||
|
COMOT-15 scores |
BET group |
41.3±10.5 |
40.3±10.5 |
39.7±10.01 |
|
|
BET + Grommet group |
40.6±10.2 |
33.3±7.5 |
30.6±6.7 |
||
|
P-value |
0.775 |
0.002 |
0.0001 |
||
As shown in Table 4, there were no statistically significant differences between the two groups in preoperative ETDQ-7 scores (BET + Grommet group: 27.3 ± 4.8 vs. BET group: 26.7 ± 4.5; P > 0.05) or Eustachian tube inflammation scale scores (BET + Grommet group: 2.9 ± 0.7 vs. BET group: 3.05 ± 0.7; P > 0.05).
Postoperatively, significant improvement was observed in both groups. The Eustachian tube inflammation scale scores decreased at 6 and 12 months in the BET + Grommet group (6 months: 1.96 ± 0.6; 12 months: 1.5 ± 0.5) as well as in the BET group (6 months: 2.7 ± 0.6; 12 months: 1.96 ± 0.6), with all comparisons reaching statistical significance (P < 0.05). However, the postoperative inflammation scores were significantly lower in the BET + Grommet group than in the BET group at both follow-up points (P < 0.05).
Similarly, ETDQ-7 scores in the BET + Grommet group showed significant reductions at 6 months (21.1 ± 4.1) and 12 months (18.7 ± 3.6) compared with preoperative values (both P < 0.05). The postoperative ETDQ-7 scores were significantly lower in the BET + Grommet group than in the BET group at both time points (P < 0.05). A normal ETDQ-7 score (≤14) was achieved by 13.9% (5/36) and 33.3% (12/36) of patients in the BET + Grommet group at 6 and 12 months, respectively, compared with only 2.8% (1/36) and 8.3% (3/36) in the BET group.
Preoperative COMOT-15 scores were comparable between the BET + Grommet group (40.6 ± 10.2) and the BET group (41.3 ± 10.5; P = 0.775), indicating no baseline difference in quality of life. Both groups demonstrated postoperative improvement at 6 and 12 months; however, the degree of improvement was significantly greater in the BET + Grommet group.
At 6 months, the COMOT-15 score decreased to 33.3 ± 7.5 in the BET + Grommet group, compared with 40.3 ± 10.5 in the BET group (P < 0.05). At 12 months, further improvement was observed in the BET + Grommet group (30.6 ± 6.7), whereas minimal change occurred in the BET group (39.7 ± 10.0), with the between-group difference remaining statistically significant (P < 0.05).
The proportion of patients able to perform a positive Valsalva maneuver was significantly higher in the BET + Grommet group than in the BET group at both 6 months (61.1% vs. 38.9%) and 12 months (83.3% vs. 55.6%) postoperatively.
Patient satisfaction rates were also higher in the BET + Grommet group. At 6 months, satisfaction was reported by 77.1% of patients in the BET + Grommet group compared with 58.3% in the BET group. At 12 months, satisfaction increased to 88.9% in the BET + Grommet group, compared with 69.4% in the BET group.
Only minor complications were observed. Two patients in the BET group reported mild postoperative tenderness, which resolved by the 6- and 12-month follow-up visits. No significant difference in adverse events was noted between the two groups.
Grommet insertion has traditionally been the mainstay surgical treatment for Eustachian tube dysfunction (ETD) and recurrent or chronic otitis media, particularly in the presence of persistent middle ear effusion unresponsive to medical therapy. Ventilation tubes help re-establish middle ear aeration, reduce inflammation, facilitate effusion clearance, and improve hearing, making them one of the most commonly performed ambulatory otologic procedures [30,31]. However, grommet insertion does not address the underlying pathophysiology of ETD and is associated with procedure-related complications. In contrast, balloon Eustachian tuboplasty (BET), first described in 2010, represents a minimally invasive technique aimed at restoring physiological Eustachian tube function and has been supported by randomized controlled trials and clinical studies over the past decade [32,33]. Given that BET alone may not consistently achieve optimal symptom control in otitis media, combined approaches using BET with grommet insertion have been increasingly explored in both otitis media and ETD [23,34,35].
Hearing improvement, commonly assessed by the air–bone gap (ABG), remains a key indicator of surgical success [36]. Chen et al. demonstrated that children with otitis media with effusion treated with BET combined with myringotomy and grommet insertion achieved significantly better ABG outcomes at 12 months compared with myringotomy alone [37]. Similarly, studies involving patients with Otitis Media with Effusion and obstructive ETD have shown greater ABG improvement when BET was added to tympanoplasty compared with tympanoplasty alone [19]. In the present study, a significant reduction in ABG was observed in the BET + Grommet group at both 6 and 12 months postoperatively, with superior postoperative ABG values compared with the BET-alone group. Furthermore, according to the Japan Clinical Otology Committee criteria [38], a postoperative ABG of ≤20 dB—indicative of meaningful hearing improvement—was achieved in a higher proportion of patients receiving the combined treatment. These findings reinforce the additive benefit of grommet insertion when combined with BET in improving hearing outcomes in OME-ETD patients.
Effective hearing rehabilitation is generally considered feasible only after restoration of adequate Eustachian tube function [39]. Previous studies have reported improvements in both the structure and function of the Eustachian tube following BET combined with grommet insertion in patients with chronic otitis media with effusion [35]. The Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) is a validated tool with high sensitivity and specificity for diagnosing ETD when scores are ≥14.5 [40]. In our study, normalization of ETDQ-7 scores was achieved in a substantially higher proportion of patients in the BET + Grommet group compared with the BET group at both follow-up intervals. Additionally, significant reductions in ETDQ-7 and COMOT-15 scores, along with higher rates of positive Valsalva maneuver, were observed in the combined treatment group, indicating superior restoration of Eustachian tube function and improved disease-specific quality of life.
Mucosal inflammation is recognized as a major contributing factor in ETD [28]. Endoscopic assessment in the present study demonstrated significant postoperative reduction in Eustachian tube inflammation scores in both groups, with more pronounced improvement in the BET + Grommet group. These findings suggest that BET, particularly when combined with grommet insertion, may alleviate ETD by reducing mucosal inflammation, improving middle ear ventilation, and thereby enhancing hearing outcomes and health-related quality of life in patients with OME-ETD.
The primary strength of this study lies in its comprehensive evaluation of functional hearing outcomes, Eustachian tube function, inflammatory status, and patient-reported quality of life following combined BET and grommet insertion. However, several limitations must be acknowledged. First, the retrospective design and absence of a non-surgical control group may limit the strength of causal inference. Second, the follow-up period was limited to 12 months; longer-term outcomes are required to determine the durability of treatment benefits. Future large-scale, prospective randomized controlled trials with extended follow-up are warranted to further validate these findings
Balloon Eustachian tuboplasty combined with grommet insertion demonstrates superior therapeutic efficacy compared with BET alone in patients with OME-ETD. The combined approach results in greater improvement in hearing outcomes, enhanced Eustachian tube function, reduced mucosal inflammation, improved quality of life, and higher patient satisfaction, with minimal complications. This strategy represents an effective and clinically meaningful treatment option for patients with otitis media with effusion associated with Eustachian tube dysfunction.
Conflicts of Interest: The authors declare no conflicts of interest.