Surgical Outcomes in Chronic Otitis Media: Hearing and Quality of Life Improvements

Abstract

Chronic Otitis Media (COM) is a persistent middle ear infection that can cause hearing impairment and significantly impact a patient’s quality of life (QoL). While surgical interventions such as tympanoplasty are well-recognized for improving hearing, their broader effects on QoL remain less thoroughly investigated. To evaluate the impact of ear surgery on both audiometric outcomes and QoL in patients with COM, using validated patient-reported outcome measures. This prospective analytical study was conducted in the Department of ENT at a tertiary care hospital, involving 120 adult patients diagnosed with COM. Changes in QoL were assessed using validated tools: the Chronic Ear Survey (CES) and the Chronic Otitis Media Outcome Test-15 (COMOT-15) questionnaires, administered both pre- and post-surgery. Audiometric outcomes were measured using Pure Tone Audiometry (PTA). Post-operative evaluations demonstrated significant improvements in both audiometric outcomes and QoL. The mean air-bone (AB) gap decreased from 28.92 ± 8.83 dB pre-operatively to 16.47 ± 5.86 dB post-operatively. CES scores increased from 58.45 ± 9.01 to 76.19 ± 8.33, while COMOT-15 scores improved from 56.65 ± 12.16 to 22.81 ± 8.52. These improvements were statistically significant (p < 0.001). Ear surgery in patients with COM significantly enhances both hearing function and QoL. These findings emphasize the necessity of incorporating patientreported outcome measures, such as QoL assessments, in evaluating surgical success and underscore the importance of timely surgical interventions for comprehensive patient care.

Introduction

Chronic Otitis Media (COM) is a persistent middle ear infection that often results in irreversible mucosal damage and complications such as hearing impairment and the potential involvement of adjacent structures like the mastoid and brain. This condition not only leads to functional limitations due to hearing loss but also significantly impacts social interactions and professional life. Hearing impairment associated with COM can hinder communication, frequently causing patients to withdraw socially. Additionally, symptoms such as chronic ear discharge, discomfort, and the need for repeated medical visits further diminish quality of life (QoL), exacerbating the emotional and psychological burden of the disease [1].

Globally, COM affects millions of individuals, with a particularly high burden in regions like South-East Asia and Africa, where access to comprehensive healthcare is limited [2]. In India, the prevalence of COM is estimated to be 5.2%, posing a significant public health challenge [3]. While surgical interventions like tympanoplasty are well-established for their efficacy in improving auditory outcomes and eradicating disease, their broader impact on patients’ overall QoL remains underexplored [4]. Even after hearing restoration, patients with COM may continue to experience symptoms such as discharge, tinnitus, and balance disturbances, which can interfere with daily activities and adversely affect emotional well-being. A better understanding of these aspects is essential for optimizing care and achieving better outcomes in COM management.

The importance of considering subjective outcomes in COM treatment was first highlighted in 2008, which marked a shift in focus from solely objective measures, such as hearing recovery and recurrence rates, to a broader perspective encompassing patient-reported outcomes [5]. Building on this approach, our study aimed to evaluate the specific impact of ear surgery on the QoL of patients with COM. We conducted a prospective analysis using validated patient-reported outcome measures (PROMs) to assess changes in QoL following surgical intervention. By integrating subjective evaluations with clinical parameters, this study offers valuable insights into the holistic benefits of ear surgery, emphasizing the importance of a patient-centred approach in the management of COM.

Material & Methods

This analytical study was conducted following ethical approval from the Institutional Ethical Committee over a two-year period in the Department of ENT at a tertiary care hospital. Written informed consent was obtained from all participants before enrolment, ensuring they were fully aware of the study objectives, procedures, potential risks, and benefits. The study adhered to ethical guidelines for research involving human subjects, maintaining confidentiality and patient autonomy throughout. The study aimed to evaluate the impact of ear surgery on QoL and hearing outcomes in patients with COM. A cohort of adult patients diagnosed with COM was enrolled based on specific inclusion and exclusion criteria to ensure the validity and reliability of the findings.

Eligible participants were aged 18 years or older, had not undergone previous ear surgery, and were deemed fit for surgical intervention. Patients requiring revision surgery were excluded to maintain sample homogeneity, as revision procedures often present unique challenges and outcomes that could confound the results. Additionally, patients with moderate to severe sensorineural hearing loss (SNHL) were excluded. Since SNHL is typically resistant to improvement through middle ear surgeries, including these patients could have introduced variability and reduced the accuracy of audiological outcome measures. By focusing on individuals with normal cochlear function or mild SNHL, the study sought to capture meaningful improvements in air conduction pathways, ensuring that the results reflected the true impact of middle ear surgical procedures.

Patient demographics, including age, gender, type of surgery (primary or revision), and unilateral or bilateral disease, were documented pre-operatively. Detailed clinical examinations assessed the tympanic membrane status, presence of middle ear mucosa abnormalities, cholesteatoma, or retraction pockets. Baseline Pure Tone Audiometry (PTA) was performed to assess hearing loss.

To assess QoL, two validated questionnaires, the Chronic Ear Survey (CES) [6] and the Chronic Otitis Media Outcome Test-15 (COMOT-15) [7], were employed. The CES, developed in 2000, evaluates the impact of COM on daily activities, symptom burden, and medical resource utilization. However, it does not address the psychological or emotional aspects of the disease. To address this gap, the COMOT-15, introduced in 2009, incorporates subscales for ear symptoms, hearing function, and mental health, offering a more comprehensive evaluation of QoL. Together, these tools allowed for a broader assessment of how COM affects various dimensions of patients’ lives.

The questionnaires were available in both Hindi and English to ensure accessibility for the diverse study population. Professional translators were employed for translation to Hindi, who conducted forward and backward translations to ensure linguistic and contextual accuracy. Patients self-administered the questionnaires, but assistance was provided to illiterate participants to minimize response bias. The CES assessed three subscales: activity restriction (AR), symptom presence (SP) and medical resource utilization (MR), with scores ranging from 0 to 100. Higher scores indicated better health, while lower scores suggested poorer outcomes. Conversely, COMOT-15 scores were inversely scaled, with lower scores indicating better health and higher scores reflecting greater impairment. The COMOT-15 questionnaire included subscales for ear symptoms (questions 1–6), hearing function (questions 7–9) and mental health (questions 10–13), along with two additional questions addressing the overall impact of COM and the frequency of medical visits related to the condition.

Surgical interventions were customized based on the severity and pathology of the disease. Procedures included tympanoplasty and canal wall up/down techniques, among others, to address the full spectrum of middle ear pathology encountered in routine clinical practice. The study’s objective was not to compare specific surgical techniques but to evaluate the overall effectiveness of surgical intervention in improving QoL and hearing outcomes. Since each procedure was tailored to the patient’s condition, the pre- and post-operative comparisons represented the specific benefit derived from the intervention.

Most procedures were performed under local anaesthesia to enhance patient safety and minimize recovery time, with general anaesthesia reserved for extensive surgeries or patients experiencing significant anxiety. Post-operatively, patients were closely monitored through follow-up visits at one week, one month and three months. During these visits, graft integrity, symptom resolution and any post-surgical complications were assessed. At the three-month mark, repeat PTA and CES/COMOT-15 questionnaires were administered to evaluate changes in audiological and QoL outcomes.

Data were meticulously recorded in Microsoft Excel and analysed using IBM SPSS Statistics version 29.0. Continuous variables were expressed as mean ± standard deviation (SD). Paired t-tests were used to compare pre- and post-operative values, and statistical significance was set at a p-value of < 0.05. This robust methodological approach ensured that the findings were both reliable and clinically meaningful.

Results

A total of 120 patients, comprising 63 males (52.5%) and 57 females (47.5%), were included in the study. (Table 1). The majority of patients 73 (60.8%) were in the 21–50 years age group, while 6 (5%) were under 20 years and 41 (34.2%) were above 51 years. The disease was unilateral in most cases, with 64 patients (53.3%) undergoing surgery in the right ear and 56 patients (46.7%) in the left ear.

Table 1.

Demographic and clinical characteristics of the study population

Parameter	Characteristics	N (%)
Gender	Male	63 (52.5%)
	Female	57 (47.5%)
Age (years)	< 20	6 (5%)
	21–50	73 (60.8%)
	> 51	41 (34.2%)
Side operated	Right	64 (53.3%)
	Left	56 (46.7%)
Diagnosis	COM-mucosal: right	57
	COM- mucosal: left	59
	COM- squamosal: right	12
	COM- squamosal: left	4
Surgical Procedures	Type I Tympanoplasty	96 (80%)
	Type II Tympanoplasty	4 (3%)
	Cortical mastoidectomy with Type 1 Tympanoplasty	2 (2%)
	Modified Radical Mastoidectomy/ Atticotomy	18 (15%)

Regarding diagnoses, mucosal disease was identified in 116 ears, while squamosal disease was diagnosed in 16 ears, as some patients had bilateral involvement. The most common surgical procedure performed was Type I Tympanoplasty, accounting for 96 cases (80%). Ossicular reconstruction with Type II Tympanoplasty was performed in four patients (3%). Cortical Mastoidectomy combined with Type I Tympanoplasty was undertaken in two patients (2%) and Modified Radical Mastoidectomy or Atticotomy was performed in 18 patients (15%). Table 1 summarises the demographic and clinical characteristics of the study population.

The pre-operative air-bone (AB) gap was 28.92 ± 8.83 dB, which significantly decreased to 16.47 ± 5.86 dB post-operatively, indicating substantial improvement in hearing outcomes following surgery. Similarly, the CES score improved significantly from a pre-operative value of 58.45 ± 9.01 to a post-operative value of 76.19 ± 8.33. Notably, all individual CES subscales, including AR, ST and MR, also showed statistically significant post-operative improvements.

The COMOT-15 scores demonstrated a marked decrease from 56.65 ± 12.16 pre-operatively to 22.81 ± 8.52 post-operatively, reflecting substantial enhancement in quality of life. All COMOT-15 subscales, including Ear Symptoms (ES), Hearing Function (HF), Mental Health (MH), Impact of COM (QL) and Frequency of Doctor Visits (FD), recorded statistically significant reductions post-operatively, highlighting the broad-spectrum benefits of surgical intervention. Table 2 provides a detailed comparison of pre-operative and post-operative CES and COMOT-15 scores, including subscale analyses, with corresponding p-values confirming statistical significance.

Table 2.

Pre-operative, 3-Month post-operative and difference between Pre-operative and Post-operative CES and COMOT-15 scores

	Pre-op	Post-op	t-value	P value
	Mean ± SD*	Mean ± SD*
Chronic Ear Survey(CES)	58.45 ± 9.01	76.19 ± 8.33	35.69	< 0.001
Activity Restriction(AR)	51.25 ± 10.97	68.4 ± 10.48	19.65	< 0.001
Symptoms Presence(ST)	50.82 ± 13.36	69.29 ± 10.89	13.46	< 0.001
Medical Resources Utilization(MR)	73.1 ± 16.89	91.03 ± 7.78	16.55	< 0.001
Chronic Otitis Media Outcome Test-15 (COMOT-15)	56.65 ± 12.16	22.81 ± 8.52	39.09	< 0.001
Ear Symptoms(ES)	66.22 ± 12.12	30.62 ± 10	39.57	< 0.001
Hearing Function(HF)	66.21 ± 12.7	31.39 ± 9.94	35.8	< 0.001
Mental Health(MH)	64.19 ± 13.47	29.64 ± 10.45	33.72	< 0.001
Impact of COM(QL)	41.67 ± 22.09	9.67 ± 11.59	17.4	< 0.001
Frequency of Doctor Visit(FD)	45 ± 21.1	12.85 ± 12.11	18.08	< 0.001

*Data is expressed as Mean ± Standard Deviation

Correlations were calculated between CES, COMOT-15 scores and PTA thresholds to assess the relationship between QoL and hearing thresholds. The trend lines in Graphs 1 and 2 show a weak positive correlation between CES and PTA and a weak negative correlation between COMOT-15 and PTA pre-operatively. Post-operatively, these relationships shifted, with CES displaying a weak negative correlation and COMOT-15 a weak positive correlation, reflecting better disease outcomes and patient improvement.

Graph 1.

Correlation between pre-operative PTA and CES and COMOT-15 scores

Graph 2.

Correlation between post-operative PTA and CES and COMOT-15 scores

Discussion

The current study evaluates the impact of surgical interventions on the QoL in patients suffering from COM. Our findings demonstrate that ear surgery significantly improves both audiometric outcomes and QoL, as assessed through the CES and the COMOT-15. The CES focused on functional limitations, symptoms, and healthcare utilization, while the COMOT-15 provided deeper insights into the mental health impact of the condition, offering a more nuanced understanding of how COM affects patients’ overall well-being. Together, these tools addressed gaps left by earlier assessments, which often neglected the psychological and emotional dimensions of the disease. This combination of validated tools proved to be integral in capturing the multifaceted improvements brought about by surgical intervention.

It is essential to use validated tools like CES and COMOT-15 for assessing QoL alongside audiometric measures, as they provide a more comprehensive understanding of the benefits of surgery. Studies by Lailach et al. [8] and Lucidi et al. [9, 10] examined different surgical techniques for COM, including Canal Wall Down (CWD) and Canal Wall Up (CWU) procedures. Lailach et al. found no significant differences in overall COMOT-15 scores between exclusively transcanal (ETC) and combined transcanal transmastoidal (TCM) techniques. However, CWD patients required more ENT consultations and reported slightly poorer auditory results, although their QoL improved significantly over time, likely due to gradual healing. Similarly, Lucidi et al. noted that while hearing function differed significantly between CWU and CWD, overall QoL scores were similar at 12 months post-surgery. These findings underscore that while specific techniques may influence audiometric outcomes, QoL improvements often transcend such differences. They also highlight that subjective QoL measures may not directly correlate with objective metrics like PTA thresholds. A patient’s QoL and perceived outcomes are shaped by factors beyond auditory function, such as the psychological relief from resolving persistent symptoms like ear discharge or the comfort of achieving a dry ear after surgery. Thus, assessing both the emotional and psychosocial aspects of recovery is crucial in evaluating the success of surgical interventions.

In this study, a range of surgical procedures was included to assess their collective impact on patient outcomes. The rationale for this approach lies in our objective to evaluate the overall effectiveness of ear surgery in improving QoL and audiological performance, rather than comparing specific techniques. Each surgery was tailored to the individual’s pathology, and the pre- and post-operative comparisons for each patient reflect the specific benefits they derived. Acknowledging that clinical scenarios for different COM procedures can vary, this study focused on capturing the broader advantages of surgical intervention. While future research may focus on dissecting the impact of individual procedures, our study emphasizes the principal benefits of ear surgery in enhancing QoL.

Hearing restoration remains a primary goal of surgery in COM, particularly by addressing conductive hearing loss caused by tympanic membrane perforation or ossicular chain disruption. To ensure the reliability of audiometric outcomes, we deliberately excluded patients with moderate to severe SNHL, as such cases typically do not respond to middle ear surgery. Our selection of patients with normal cochlear function or mild SNHL aimed to accurately reflect the positive outcomes specifically resulting from surgical intervention. The mean AB gap in our study improved significantly from 28.92 ± 8.83 dB pre-operatively to 16.47 ± 5.86 dB post-operatively, with an average gain of 12.49 ± 6.3 dB. These findings align with previous research, including studies by Yung et al. [11] and Westerberg et al. [12], which reported similar improvements in audiometric outcomes following tympanoplasty. Such gains are clinically significant, as even modest improvements in hearing can greatly enhance a patient’s ability to communicate and engage in daily activities. This is especially pertinent in the Indian context, where hearing impairment due to COM is prevalent and often under-treated, leading to substantial social and occupational challenges for affected individuals.

In addition to these objective audiometric measures, our study revealed significant improvements in all subscales of both CES and COMOT-15 post-operatively. CES scores showed notable reductions in activity restriction, symptoms, and medical resource utilization, indicating a substantial alleviation of the physical and psychological burdens associated with COM. Similarly, COMOT-15 scores demonstrated significant post-operative improvements across subscales for ear symptoms, hearing function, and mental health. The most pronounced changes were observed in the mental health and overall QoL subscales, suggesting that surgery not only alleviates the physical symptoms of COM but also has a profound positive impact on patients’ mental well-being. These findings align with those reported by Baumann et al. [13], who highlighted that surgical intervention in COM patients leads to significant improvements in disease-specific QoL.

The factors contributing to these improvements in QoL are multifaceted. First, the resolution of symptoms such as ear discharge and tinnitus post-surgery reduces physical discomfort and psychological distress. Second, the restoration of hearing function enhances patients’ ability to communicate effectively, improving their social interactions and reducing feelings of isolation. Finally, the reduction in the need for medical care, as reflected in the improved medical resource utilization subscale of CES, contributes to a sense of regained control over health, further bolstering QoL. Studies by Bakir et al. [14] and Choi et al. [15] similarly reported that surgical intervention not only improves hearing but also reduces vertigo and tinnitus, leading to enhanced overall QoL.

The findings of this study have important clinical implications. They underscore the value of incorporating QoL measures into the evaluation of surgical outcomes in COM patients. Traditional audiometric assessments, while vital, do not fully capture the impact of COM on patients’ lives. Subjective measures like CES and COMOT-15 provide a more comprehensive understanding of treatment efficacy, enabling clinicians to better guide decision-making. Additionally, the significant improvements in QoL observed post-surgery highlight the importance of timely intervention, especially in resource-limited settings where delayed treatment can exacerbate disease progression, increase complications, and burden healthcare systems. Early surgical intervention not only improves hearing but also addresses the psychosocial and emotional toll of COM, ensuring better long-term outcomes.

While this study provides valuable insights into the impact of ear surgery on QoL, it is not without limitations. The single-centre design may limit the generalizability of the findings, and the follow-up period of three months post-operatively may not capture the long-term effects of surgery. Future studies with larger sample sizes and extended follow-up durations are essential to confirm the sustainability of these improvements. Despite these limitations, the study underscores the importance of patient-centred care in the management of COM and highlights how surgical interventions can profoundly enhance patients’ overall well-being.

Conclusion

In conclusion, this study demonstrates that ear surgery significantly improves both audiometric outcomes and QoL in patients with Chronic Otitis Media. The findings highlight the importance of considering both objective and subjective measures when evaluating surgical outcomes and underscore the value of timely surgical intervention in enhancing the overall well-being of COM patients.

Funding

Nil.

Declarations

Ethical approval

The research involved human participants. Informed consent was taken from all the patients.

Financial disclosure

Nil.

Presentation at a meeting

Nil.

Conflict of interest

There is no potential conflicts of interest.