Abstract
Stapedotomy is an effective surgical intervention used for the treatment of conductive hearing loss associated with otosclerosis. The present study aims to quantitatively evaluate the hearing outcomes following primary stapedotomy performed in patients with otosclerosis. It also aims to investigate frequency-specific hearing results of stapedotomy in these patients. This retrospective study enrolled 49 patients with clinical otosclerosis, who underwent primary stapedotomy at a tertiary-care hospital, between January 2014 and December 2019. Pure-tone audiometry (PTA) was performed pre and post-operatively (> 1 year after surgery). Post-operative air conduction (AC) and bone conduction (BC) thresholds were recorded. The primary outcome measure was post-operative air–bone gap (ABG). Low frequency (LF) ABG was calculated as the mean ABG of thresholds at 0.5 and 1 kHz. High frequency (HF) ABG was calculated as the mean ABG of thresholds recorded at 2 and 4 kHz. In all the study patients, the mean post-operative AC and the mean postoperative BC thresholds, showed significant improvement across the tested frequencies of 0.5, 1, 2 and 4 kHz (P < 0.05). The mean post-operative ABG closure was superior at HF, as compared to that at LF (9.54 ± 6.30 dB vs. 12.0 ± 6.63 dB, P = 0.014). A successful surgical outcome (post-operative ABG closure to ≤ 10 dB) was achieved in 61.22% of the study patients. Further, a greater number of patients (71.45%) recorded successful surgical outcome at HF, when compared with those at LF (46.95%, P < 0.05). Favourable hearing outcomes of this study underscore the effectiveness of primary stapedotomy in the treatment of patients with clinical otosclerosis. Better postoperative ABG closure to ≤ 10 dB was recorded at higher frequencies. Further studies assessing post-stapedotomy hearing results at HF are warranted for ensuring better hearing outcomes in the HF range as well.
Supplementary Information
The online version contains supplementary material available at 10.1007/s12070-023-04126-0.
Keywords: Otosclerosis, Outcome assessment, Stapedotomy
Introduction
Otosclerosis or otospongiosis is a primary osteodystrophy of the otic capsule, in which the normal, dense endochondral layer of the bony labyrinth is replaced by bone resorption and disordered new bone formation [1]. It commonly affects the fissula ante fenestram which is an area anterior to the oval window. This causes fixation of the stapes footplate, resulting in progressive conductive hearing loss (CHL) [2–4]. Mixed and sensorineural hearing loss (SNHL) may also occur when otosclerosis involves the cochlear endosteum [5].
The current management options for treating the hearing loss associated with otosclerosis include amplification with hearing aid and surgical interventions such as partial or total stapedectomy or stapedotomy [3, 4, 6–9]. Stapedotomy is considered to be an effective surgical treatment for otosclerosis [7, 10].
Technical success following stapedotomy is measured by assessing the post-operative hearing outcomes using pure tone audiometry (PTA) [3, 4, 11]. The primary hearing outcome parameter is the postoperative air–bone gap (ABG) closure [12]. Prior studies described in the scientific literature have demonstrated a decline in the post-operative hearing gains with increasing stimulus frequency and therefore, have reported lesser benefit from stapes surgery at higher frequencies [4, 13–15]. Some studies have assessed hearing outcomes following stapes surgery in Indian patients with otosclerosis [11, 16, 17]. However, in these patients, the post-stapedotomy hearing outcomes at higher frequencies have not been comprehensively investigated.
On this background, the present study conducted at a tertiary-care hospital in India, aimed to carry out quantitative evaluation of post-stapedotomy hearing outcomes in patients with otosclerosis. A retrospective frequency-specific analysis of post-operative changes in hearing outcomes was also performed.
Materials and Methods
Selection of Participants
This retrospective study included 49 consecutive patients with otosclerosis, who underwent primary stapedotomy at a tertiary-care hospital between January 2014 and December 2019. Data of patients meeting all the following inclusion criteria were collected: (1) patients with either conductive or mixed hearing loss determined by pure tone audiometry (PTA); (2) patients with confirmed clinical diagnosis of otosclerosis; (3) treated by primary stapedotomy; (4) patients within the age group of 15–70 years. Patients with cochlear otosclerosis, sensorineural hearing loss (SNHL) or hearing loss not attributable to otosclerosis, patients undergoing revision stapes surgery and patients who failed to attend audiology assessment 1-year following stapedotomy, were excluded from the study. This study was approved by the Hospital Ethics committee and informed consent was obtained from all the study participants.
Baseline demographics, clinical characteristics, otologic and audiometric evaluations as well as procedural data of the enrolled subjects were retrospectively reviewed. Diagnosis of otosclerosis was based on audiometric evaluation and clinical findings during surgery.
Surgical Technique
All the stapedotomies were carried out by a single surgeon (NV) at a tertiary care hospital, employing the same surgical technique, under general anesthesia. Small fenestra stapedotomy technique was performed by endo-meatal approach, using operating microscope [18]. A stapedotomy fenestration was created on stapes footplate using a microdrill, rotating at a low-speed of 1000 rpm [19, 20]. Stapedotomy on the footplate was done before removal of stapes superstructure [21]. Teflon prosthesis (Fluoroplastic piston, Grace Medical, Memphis, Tennessee, United States) with a diameter of 0.6 mm was used for all the operated cases [22, 23]. Length of the prosthesis selected was 0.25 mm longer than the distance between the under surface of incus and the stapes footplate [24]. Appropriate crimping of stapes piston to the long process of incus was done and a fat plug was applied to the oval window.
Audiometric Evaluation
All the study patients underwent pure tone audiometry (PTA) pre- and post-operatively. Pre-operative audiograms were obtained one week prior to stapedotomy; whereas post-operative audiograms were performed one year after the surgery. PTA was conducted by trained personnel using a calibrated clinical audiometer (Piano Inventis, Padua, Italy). Pre- and post-operative standard pure-tone thresholds for air conduction (AC) and bone conduction (BC) were recorded at 0.5, 1, 2 and 4 kHz frequencies. Air- bone gaps (ABGs) were obtained by calculating the difference between the pure tone thresholds for AC and BC. ABG closure was calculated by subtracting the post-operative BC from the post-operative AC thresholds. A four-tone average (PTA4) was calculated for the pre- and post-operative AC, BC and ABG thresholds at 0.5, 1, 2 and 4 kHz. Low-frequency (LF) ABG was defined as the mean ABG at 0.5, and 1 kHz. Whereas high-frequency (HF) ABG was defined as the mean ABG at 2 and 4 kHz. Hearing outcome results were reported as per the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) guidelines, as much as possible [25]. However, the recommended frequency of 3 kHz was substituted with 4 kHz.
Statistical Analysis
The data was statistically analysed using Epi-Info software. Categorical variables were presented as numbers (n) and percentages (%). The quantitative continuous variables were summarised as Mean ± Standard deviation (SD). Unpaired t-test test was applied to assess the impact of gender and type of hearing loss on the audiometric outcome parameters. The statistical significance of changes in the mean thresholds of various pre- and post-operative audiometric parameters, as a function of frequency; was calculated using the paired t-test. Friedman's two-way analysis of variance (ANOVA) by ranks test was used for comparing the magnitude of frequency-specific changes between the different parameters; wherever the variance (with respect to mean) of values of these parameters was found to be greater. Wilcoxon’s signed rank test was used to compare ABG closures at low and high frequencies. P-value < 0.05 was considered statistically significant for all the statistical tests.
Results
Age of the 49 patients included in this study ranged from 17 to 66 years and the maximum number of patients (44.9%) were in the age-group of 30–40 years). Women constituted 59.2% of the study participants. Audiometric evaluation reported conductive hearing loss in 26 patients and mixed hearing loss in the remaining 23 patients. Details of the baseline characteristics of the patients are outlined in Table 1.
Table 1.
Patient characteristics (n = 49 patients)
| Patient characteristics | Number (Percentage) |
|---|---|
| Age in years | |
| Mean ± SD | 40 ± 11.53 |
| Range | 17–66 |
| Gender | |
| Male | 20 (40.8%) |
| Female | 29 (59.2%) |
| Side operated | |
| Right ear | 28 (57.1%) |
| Left ear | 21 (42.9%) |
| Type of hearing loss | |
| Conductive | 26 (53.1%) |
| Mixed | 23 (46.9%) |
n Number of patients
Table 2 summarizes the pure tone averages measured across all four frequencies (0.5 kHz, 1 kHz, 2 kHz and 4 kHz) as per AAO-HNS guidelines.
Table 2.
Summary of pure tone averages measured across four frequencies of 0.5 kHz, 1 kHz, 2 kHz and 4 kHz for the 49 stapedotomies performed; as per AAO-HNS guidelines
| Frequency | |||||
|---|---|---|---|---|---|
| Audiometric Parameters (in dB) | 0.5 kHz Mean ± SD (Range) |
1 kHz Mean ± SD (Range) |
2 kHz Mean ± SD (Range) |
4 kHz Mean ± SD (Range) |
Average of 0.5, 1, 2 & 4 kHz (PTA4) Mean ± SD (Range) |
| Pre-op AC | 68.57 ± 12.99 (45–95) |
69.08 ± 13.72 (45–95) |
62.08 ± 12.16 (40–90) |
56.43 ± 13.19 (30–95) |
64.05 ± 11.80 (43.75–87.50) |
| Post-op AC |
27.14 ± 5.86 (15–45) |
24.79 ± 7.35 (10–45) |
21.42 ± 6.84 (10–45) |
20.31 ± 7.31 (10–50) |
23.42 ± 5.78 (12.50–38.75) |
| Pre-op BC |
22.76 ± 8.29 (5–35) |
22.24 ± 8.10 (10–45) |
31.33 ± 10.35 (5–45) |
18.16 ± 10.44 (5–65) |
23.62 ± 7.67 (10–37.5) |
| Post-op BC |
14.69 ± 3.74 (5–20) |
13.27 ± 3.47 (5–25) |
11.84 ± 4.53 (5–25) |
10.82 ± 5.80 (5–30) |
12.65 + 2.88 (6.25–18.75) |
| Pre-op ABG (Pre-op AC- Pre-op BC) |
45.82 ± 9.48 (30–65) |
46.84 ± 10.80 (20–65) |
30.61 ± 10.44 (10–55) |
38.27 ± 10.83 (15–65) |
40.38 + 8.80 (21.25–58.75) |
| Post-op ABG (Post-op AC- Post-op BC) |
12.45 ± 6.93 (0–35) |
11.53 ± 7.65 (0–30) |
9.60 ± 7.42 (0–30) |
9.49 ± 6.31 (0–30) |
10.77 + 5.82 (1.25–28.75) |
All data are presented as mean ± standard deviation and (range) in dB
AC air conduction, BC Bone conduction, ABG Air–bone gap, dB Decibel, kHz Kilohertz, PTA Pure tone average, Pre-op Pre-operative, Post-op Post operative
P < 0.05 was statistically significant
Comparing Pre- and Post-operative Mean Air Conduction (AC) Thresholds
In all the patients, post-stapedotomy mean AC thresholds across the tested frequencies of 0.5 kHz, 1 kHz, 2 kHz and 4 kHz were significantly lower, as compared to the pre-operative mean AC thresholds measured at the respective frequencies; indicating a significant post-operative gain in the mean AC thresholds across all four frequencies. (P < 0.05) (Table 2, Fig. 1). The 4-tone pure tone average (PTA4) of pre-operative mean AC thresholds was 64.05 ± 11.80 dB and post-operatively it improved to 23.42 ± 5.78 dB (P < 0.05) (Table 2). Thus, a significant change of 40.63 ± 10.57 dB (63.4%) was recorded between the PTA4 of post-operative mean AC thresholds and the PTA4 of pre-operative mean AC threshold (P < 0.05).
Fig. 1.
Post-stapedotomy changes in mean AC and BC thresholds and post-stapedotomy ABG gain as a function of frequency. AC: Air conduction, BC: Bone conduction, ABG: Air–bone gap, dB-Decibel, kHz: Kilohertz
Figure 2 illustrates the comparison between pre- and post-operative mean AC thresholds at LF and HF. The magnitude of post-operative change in mean LF AC threshold (42.86 ± 11.04 dB) was found to be significantly larger than the magnitude of post-operative change in mean HF AC threshold (38.37 ± 10.83); (P = 0.007 by Friedman's two-way ANOVA by ranks test) (Figs. 1 and 2).
Fig. 2.
Pre- and Post-operative mean AC thresholds as a function of low and high frequency. AC: Air conduction, HF: High frequency, LF: Low frequency
Comparing Pre- and Post-operative Mean Bone Conduction (BC) Thresholds
As elaborated in Table 2, the post-operative mean bone conduction (BC) thresholds across all the four tested frequencies, were lower than the corresponding pre-operative mean BC thresholds and this difference was statistically significant (P < 0.05). The PTA4 of post-operative mean BC thresholds (12.65 + 2.88 dB) was significantly smaller than the PTA4 of pre-operative mean BC thresholds (23.62 ± 7.67 dB, P < 0.05) (Table 2). An overall statistically significant improvement of 46.4% was recorded in the post-stapedotomy mean BC threshold values and maximum BC gain of 62.2% was achieved at 2 kHz (Fig. 1).
Comparison between pre- and post-operative mean BC thresholds at LF and HF, showed that the magnitude of post-operative change in mean BC threshold (8.52 ± 6.75 dB) at LF was significantly smaller than the magnitude of post-operative change in mean BC threshold (13.41 ± 7.37 dB) at HF; (P = 0.000 by Friedman's two-way ANOVA by ranks test) (Fig. 3). Greater improvement in the post-stapedotomy mean BC thresholds was recorded across all four frequencies, among patients with mixed hearing loss; as compared to patients with conductive hearing loss. This difference in post-operative mean BC thresholds was statistically significant (P < 0.05).
Fig. 3.
Pre- and Post-operative mean BC thresholds as a function of low and high frequency. BC: Bone conduction, HF: High frequency, LF: Low frequency
Comparing Pre- and Post-operative Air Bone Gap (ABG)
The distribution of pre- and post-operative ABGs across the four tested frequencies for all the study patients is demonstrated in Fig. 4. The post-operative mean ABGs were significantly lower, as compared to the pre-operative mean ABGs, at all the tested frequencies (P < 0.05) (Table 2, Fig. 4). The 4-tone pure tone average (PTA4) of pre-operative mean ABG was 40.38+8.80 dB and post-operatively it significantly improved to 10.77 + 5.82 dB (P < 0.05) (Table 2). The magnitude of ABG closure was 29.62+9.20 dB.
Fig. 4.
Box-and-whisker plots showing distribution of pre-operative ABG and post-operative ABG closure at various frequencies. ABG: Air–bone gap, dB-decibel, kHz: Kilohertz
Comparing Pre- and Post-operative Mean ABG at Low and High Frequency
The pre- as well as post-operative mean LF ABG was significantly larger than the pre- and post-operative mean HF ABG, respectively (Fig. 5). Post-stapedotomy, both the mean LF and HF ABGs showed significant improvement by 34.34 ± 9.34 dB and 24.90 ± 10.13 dB, respectively (P = 0.000). However, the difference between the change in ABG (Δ ABG) at LF and the Δ ABG at HF was not statistically significant (P = 0.248 i.e., P > 0.05 by Friedman's two-way ANOVA by ranks test).
Fig. 5.
Pre- and Post-operative mean ABG as a function of low and high frequency. ABG: Air–bone gap, dB-Decibel, kHz: Kilohertz
Complying with the AAO-HNS guidelines, Table 3 reports the pre- and post- operative ABGs in 10 dB bins. Successful surgical outcome following stapedotomy is defined as a post-operative ABG closure to 10 dB or less [3, 25]. In the present study, 61.22% of the patients achieved successful surgical outcome (Table 3). An acceptable hearing outcome with a mean ABG closure within 20 dB was achieved in 47 (95.92%) patients.
Table 3.
Pre- and Post- operative ABGs in 10 dB bins, as per AAO-HNS guidelines
| Mean ABG (dB) | Pre-operative ABG bins Frequency (n (%)) | Post-operative ABG bins Frequency (n (%)) |
|---|---|---|
| ≤ 10 | 0 (0.00%) | 30 (61.22%) |
| 11–20 | 0 (0.00%) | 17 (34.70%) |
| 21–30 | 7 (14.29%) | 2 (4.08%) |
| 31–40 | 18 (36.73%) | 0 (0.00%) |
| 41–50 | 18 (36.73%) | 0 (0.00%) |
| > 50 | 6 (12.25%) | 0 (0.00%) |
| 49 (100.00%) | 49 (100.00%) |
All data are expressed as numbers (n) or percentage (%)
ABG Air–bone gap, dB Decibel, n Number of patients
Frequency-based analysis of the hearing outcomes showed that a greater number of patients (71.45%) recorded successful surgical outcome (ABG closure ≤ 10 dB) at high frequency as compared to low frequency (46.95%) and this difference in hearing outcomes was statistically significant (P-value < 0.05) (Fig. 6, Online Resource 1).
Fig. 6.
Percentage distribution of study patients based on post-stapedotomy ABG closure at low and high frequency. ABG: Air–bone gap, dB-Decibel, kHz: Kilohertz
Discussion
Stapedotomy is a highly effective treatment option for restoring otosclerosis-induced conductive hearing loss [7, 16]. The present retrospective study conducted at a tertiary care hospital in Pune, India; reported significant improvement in the post-stapedotomy hearing function of patients with otosclerosis. These results were in agreement with the previous literature [3, 4, 7–10, 12, 16, 17].
The average age of onset of hearing loss due to otosclerosis is considered to be between 15 and 40 years [26]. As expected, the maximum number of patients in this study belonged to the age group of 30–40 years. Otosclerosis is known to occur 1.4–2.0 times more frequently in women than in men [26–28]. In the present study, the distribution of otosclerosis among women and men was 1.45:1. No statistically significant association was found between the age and gender of the study patients and their hearing outcomes.
An audiological audit following stapedotomy is an essential part of the management of patients with otosclerosis, as it provides valuable information about the patients’ hearing status and helps guide decisions about further treatment. This study reported the results of pure-tone audiometry performed for quantitative evaluation of pre- and post-operative hearing outcomes, adhering to the AAO-HNS guidelines in the best possible way [25]. However, while performing PTA, 3 kHz was replaced by 4 kHz as it is not common practice at our centre to measure at 3 kHz. Besides, a study conducted by Berliner, et al. reported that there was no major difference in the PTA4 if 3 kHz was substituted by 4 kHz [29, 30]. The mean pre- and post-operative AC and BC thresholds along with mean ABG values were therefore recorded at 0.5, 1, 2 and 4 kHz frequencies for the present study.
Overall, 61.22% of the study patients achieved successful surgical outcome with post-operative mean ABG closure to ≤ 10 dB (Table 3) [3, 25]. These results were comparable to those achieved by Adedeji et al. who in their retrospective review, reported an ABG < 10 dB in 61.1% of their cases [16]. While assessing long-term hearing results of stapedotomy, Dhooge et al. recorded slightly better results with an ABG ≤ 10 dB in 70.7% of cases [12]. Further, the present study recorded a mean ABG closure to within 20 dB in 95.91% of the patients. Previous work by Adedeji et al. demonstrated an ABG closure to within 20 dB in 85.2% of the cases; whereas Dhooge et al. recorded an ABG closure within 20 dB in 92.3% of their cases [12, 16]. About 70% of patients recorded an ABG within 20 dB in a similar study conducted by Alzhrani et al. [3]. Thus, as compared to these studies, the present study achieved better outcomes.
Frequency-specific analysis of the hearing results showed that a significantly greater number of study patients (71.45%) recorded successful surgical outcome (ABG closure ≤ 10 dB) at high frequency as compared to low frequency (46.95%) (P-value < 0.05) (Fig. 6, Online Resource 1). These were contrary to the findings recorded by some of the previously published, similar studies assessing 1 year post-stapedotomy hearing outcomes. The study conducted by Roychowdhury et al. reported greater closure of LF ABG than HF ABG, following stapedotomy [4]. Similarly, Bagger-Sjöbäck et al. in their study, found a larger post-stapedotomy hearing gain at lower frequencies as compared to higher frequencies [15]. These authors reported a decline in high frequency hearing after the stapes surgery. Strömbäck et al. also observed hearing deterioration at higher frequencies of 4, 6, and 8 kHz in 6.5% of their cases [14].
Dornhoffer, et al. in their study assessing long-term results of small fenestra stapedotomy, noted that small fenestra stapedotomy technique resulted in better closure of ABG at higher frequencies [31]. Similarly, Xie et al. in their retrospective review comparing various surgical techniques used for otosclerosis, reported better post-operative hearing thresholds at high frequency in patients who underwent small fenestra stapedotomy [32]. Balu et al. compared the outcomes of small versus large fenestra stapedotomy in patients with otosclerosis and observed that the small fenestra group showed a more significant improvement in the post-operative ABG closure at 4 kHz than the large fenestra group [33]. In the present study, small fenestra stapedotomy technique was performed for all patients. This may explain the better results achieved at HF in these patients.
Similar to the observations reported by Roychowdhury et al. and Vivek et al. in their respective studies; the present study noted that the magnitude of post-operative change in mean AC threshold at LF (42.86 ± 11.04 dB), was significantly larger than the magnitude of change at HF (38.37 ± 10.83); (P = 0.007) [4, 17].
Small size of the study population is one of the major limitations of this single-centre study. Patients were not categorized based on the severity of otosclerosis. Detailed assessment of the impact of various surgical factors on the hearing outcomes of the patients with otosclerosis; was beyond the scope of this study.
Conclusion
Microdrill-assisted, small fenestra stapedotomy with placement of a 0.6-mm Teflon piston performed in patients with otosclerosis at a tertiary-care hospital in India, yielded successful surgical outcomes. This reiterates that stapedotomy is an effective surgical treatment for improving the hearing function of patients with clinical otosclerosis.
Otosclerosis patients with pronounced high-frequency hearing loss have a higher risk of worsening tinnitus [15]. Hence, post-surgical improvement of hearing across all frequencies, including higher frequencies is imperative. In this context, the current study reported a greater closure of ABGs at high frequency (HF) following small fenestra stapedotomy. Further multi-centre studies focussing on the measurement of high frequency ABGs are warranted for assessing the impact of different procedural techniques or prosthesis design on HF hearing outcomes. This would aid in providing realistic expectations to the patients during pre-surgical counselling.
Supplementary Information
Below is the link to the electronic supplementary material.
Supplementary file1 Table showing distribution of patients based on the post-stapedotomy ABG closures achieved, as a function of frequency (PDF 382 KB)
Acknowledgements
The authors would like to acknowledge the staff of Audiology Department of KEM Hospital for their technical support. The authors also thank Mrs. Aruna Deshpande MSc. (Statistics), for her help in statistical analysis.
Author Contributions
Conceptualization NV, VV and KW; Methodology NV, VV and AK; Data curation KW, VV and AC. Formal analysis and Investigation NV, KW, VV and AK. Writing-original draft KW and AC. Writing-review & editing NV, VV and AK. Resources NV. Supervision NV and VV. Approval of final manuscript KW, NV, AC, VV and AK.
Funding
No funds, grants, or other support was received.
Data Availability
Data, materials and pro-forma of the data taken is available with the first author and corresponding author for review.
Code Availability
Not applicable (no special Software used).
Declarations
Conflict of interest
The authors have no competing interests to declare that are relevant to the content of this original article.
Ethical Approval
This work was approved by the Hospital/ Institutional Ethics Committee of KEM Hospital, Pune 411011, Maharashtra, India. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.
Informed Consent
Written-Informed consent was obtained taken from all the study patients.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Supplementary file1 Table showing distribution of patients based on the post-stapedotomy ABG closures achieved, as a function of frequency (PDF 382 KB)
Data Availability Statement
Data, materials and pro-forma of the data taken is available with the first author and corresponding author for review.
Not applicable (no special Software used).