Outcomes for high-dose intratympanic dexamethasone (24 mg/mL): a retrospective single-surgeon cohort study in sudden sensorineural hearing loss, Ménière’s disease, and labyrinthitis
Original Article

Outcomes for high-dose intratympanic dexamethasone (24 mg/mL): a retrospective single-surgeon cohort study in sudden sensorineural hearing loss, Ménière’s disease, and labyrinthitis

Shifa Wong1 ORCID logo, Nadine De Alwis1,2

1Department of ENT Surgery, Alfred Hospital, Melbourne, Australia; 2Sovereign ENT & Specialists, Ballarat, Australia

Contributions: (I) Conception and design: Both authors; (II) Administrative support: Both authors; (III) Provision of study materials or patients: N De Alwis; (IV) Collection and assembly of data: S Wong; (V) Data analysis and interpretation: S Wong; (VI) Manuscript writing: Both authors; (VII) Final approval of manuscript: Both authors.

Correspondence to: Shifa Wong, MBChB, MSc, BSc (Hons). Department of ENT Surgery, Alfred Hospital, 55 Commercial Rd, Melbourne 3004, Australia. Email: shifawong@gmail.com.

Background: Intratympanic steroids (ITS) deliver superior peri-lymph concentrations whilst minimising systemic toxicity. Optimal dosing, timing, and efficacy is uncertain; however, higher concentrations have been associated with superior outcomes. The objective of this study was to evaluate outcomes of high-dose intratympanic dexamethasone (24 mg/mL) in sudden sensorineural hearing loss (SSNHL), Ménière’s disease (MD), and labyrinthitis.

Methods: A retrospective cohort study was performed on 66 patients who received 141 high-dose intratympanic dexamethasone (24 mg/mL) injections by a single surgeon between 2020 and 2024. Demographics, symptoms, outcomes, and pre- and post-treatment pure-tone average (PTA) results were analysed.

Results: In SSNHL (n=30; 47 injections), mean PTA gain was 18.6±51.1 dB [95% confidence interval (CI): 3.7–33.6, P=0.02], with clinically significant recovery (≥15 dB) in 57.4% (27/47) of injections. The mean time to treatment from hearing loss onset was 46.0±22.7 days (range: 3–109 days), with 82% (39/47) of injections administered beyond the traditional 28-day treatment window. Salvage ITS therapy following systemic steroids demonstrated a non-significant trend towards greater hearing improvement (mean gain 21.7±59.0 dB; 95% CI: 0.4–43.0, P=0.055) with 56% (18/32) injections showing clinically significant recovery, compared with primary therapy ITS alone (mean gain 12.0±28.2 dB; 95% CI: −3.6 to 27.6, P=0.12), with a 60% (9/15) recovery rate. In labyrinthitis (n=6), mean PTA improved by 37.5±69.7 dB (95% CI: −12.4 to 87.4); however, it was not statistically significant (P=0.12). In MD (n=30; 84 injections), 75% reported sustained vertigo control with quarterly injections. No long-term complications were observed.

Conclusions: Clinically significant recovery (≥15 dB) was observed in 57.4% of SSNHL with high-dose intratympanic dexamethasone (24 mg/mL), despite the majority receiving delayed treatment. The greatest benefit was seen in salvage therapy after systemic steroids, although gains were modest (21.7 dB). Importantly, these findings suggest ITS may represent a potential therapeutic option beyond the conventional 28-day treatment window. The greatest clinical utility of high-dose ITS, however, may be in providing sustained vertigo control in refractory MD using a quarterly injection regimen.

Keywords: Sudden sensorineural hearing loss (SSNHL); intratympanic steroids (ITS); dexamethasone; Ménière’s disease (MD)


Received: 11 November 2025; Accepted: 15 May 2026; Published online: 26 August 2026.

doi: 10.21037/ajo-2025-1-81


Introduction

Since its introduction in the 1990s, there has been growing interest in intratympanic steroids (ITS) (1). By bypassing the blood-labyrinthine barrier and avoiding first pass metabolism, ITS are thought to achieve superior peri-lymph concentrations within the inner ear, while reducing overall steroid exposure and systemic complications. Previous studies support ITS in sudden sensorineural hearing loss (SSNHL) refractory to systemic steroids, in Ménière’s disease (MD) unresponsive to medical therapy, and in autoimmune inner ear disease. However, uncertainties remain regarding optimal dose, timing, and efficacy.

SSNHL has an annual incidence of approximately 66,000 cases in the USA (2). It is defined as rapid onset within 72 hours with at least a 30 decibel (dB) reduction in at least three consecutive frequencies (3), although smaller threshold shifts are also described in the literature and often considered clinically significant. Aetiology falls into: 1% retrocochlear pathology; 10–15% other causes (e.g., Ménière’s, autoimmune, infectious, trauma); and 85% idiopathic (4). Steroids are the mainstay of treatment and are thought to decrease inner ear inflammation, improve cochlear blood flow, and protect against cochlear ischaemia (5). Despite this, there is an uncertain evidence base for steroids in SSNHL with success rates ranging from 8% to 95% (3,6), with a large proportion who still show no recovery (30–50%) even with steroids (7). When ITS have been evaluated as a primary therapy, results have been extremely varied (8). A recent systematic review found little to no improvement when compared to placebo (9). The best evidence for ITS is in salvage therapy for SSNHL refractory to systemic steroids with additional improvement of 38–53% (10,11). Methylprednisolone demonstrates superior round window membrane permeability compared with dexamethasone; however, it causes greater discomfort and pain limiting its intratympanic use and supporting dexamethasone as the preferred option (3,12,13). The optimal intratympanic dexamethasone concentration remains controversial with recent guidelines recommending compounded 16–24 mg/mL, with higher concentrations associated with superior outcomes (14). The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) suggests 0.4–0.8 mL of 24 mg/mL intratympanic dexamethasone into the middle ear space every 3–7 days for a total of 3–4 sessions either as initial or salvage treatment (14,15). In practice, performing injections at such frequent intervals is often challenging in both public and private outpatient settings, and there is limited evidence to justify inpatient admission solely for this purpose.

MD is a debilitating inner ear disease characterised by vertigo, fluctuating low- to mid-frequency sensorineural hearing loss, and aural fullness. The pathophysiology involves elevated interleukin-1β and tumour necrosis factor-α, supporting the concept of a chronic inflammatory inner ear disorder and providing a mechanistic rationale for its steroid-responsiveness (16). The AAO-HNS guidelines recommend offering ITS to patients with active MD not responsive to medical treatment. ITS has shown efficacy in refractory MD by reducing vertigo attacks for up to 2 years after a single course of two 62.5 mg/mL methylprednisolone injections in a double-blind randomised controlled trial (17). It is also first-line in autoimmune ear disease and has been found to reduce refractory tinnitus (18). The role of ITS in labyrinthitis is less well defined.

The aim of this retrospective single-surgeon study is to evaluate outcomes of high-dose intratympanic dexamethasone (24 mg/mL) across SSNHL, MD, and labyrinthitis. This is one of few Australian studies to evaluate high-dose intratympanic dexamethasone (24 mg/mL) across multiple inner-ear pathologies.


Methods

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Approval was provided by the institutional ethics board of the Alfred Hospital Ethics Committee (code: EC00315; project number: 58/25 and 434/24) and individual consent for this retrospective analysis was waived. The study is reported according to the STROBE reporting guidelines (available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-81/rc).

A retrospective single-centre, single-surgeon cohort study was conducted of all patients who received ITSs at a single regional clinic in Victoria, Australia, between January 2020 and August 2024. SSNHL was defined as rapid onset sensorineural hearing loss within 72 hours with at least a 20 dB reduction across three consecutive frequencies. Labyrinthitis was diagnosed clinically in patients presenting with acute vestibulopathy and hearing loss consistent with inner ear pathology. Data on demographics, pathology, use of steroids, audiometric thresholds, outcomes, and adverse effects were collected and analysed in Microsoft Excel, version 16.0 (Microsoft Corporation, Redmond, WA, USA). Graphs and figures were also generated using Microsoft Excel. Audiometric outcomes were assessed using the summed difference between pre- and post-treatment hearing thresholds across matching frequencies. Frequencies included 250 Hz, 500 Hz, 1 kHz, 2 kHz, 3 kHz, 4 kHz, 6 kHz, and 8 kHz where available. Only paired audiograms with matching frequency measurements were included. Bone-conduction thresholds were preferentially used; air-conduction thresholds were substituted when bone-conduction thresholds were unavailable. This substitution may introduce measurement bias. Outcomes were analysed on a per-injection basis, with each ITS injection treated as an individual observation. As multiple injections were administered to some patients, observations are not statistically independent. No adjustment for within-patient clustering (e.g., mixed-effects modelling) was performed, and results should therefore be interpreted as exploratory. Descriptive statistics were used for all analyses. Continuous variables are presented as mean ± standard deviation (SD), range and 95% confidence intervals (CIs), while categorical variables are presented as counts and percentages. Pre- and post-treatment audiometric outcomes were compared using paired two-tailed t-tests. Correlation between time to treatment and audiometric improvement was assessed using simple linear regression and reported using R2 values. Statistical significance was defined as P≤0.05. Given the relatively small sample size and exploratory nature of the study, formal testing for normality was not performed; however, t-tests were considered appropriate as audiometric change was treated as a continuous variable. Outcomes for patients with SSNHL were assessed using Siegel’s Criteria (19) and further analysed using a modified version of Siegel’s Criteria incorporating a baseline hearing grade to improve prognostic discrimination and identify non-serviceable ears (20). MD was defined either clinically using the 2015 Bárány Society criteria for probable or definite MD (21), or supported by radiological evidence of lymphatic hydrops on magnetic resonance imaging (22,23). For MD, outcomes were assessed through retrospective review of clinical documentation. Vertigo outcomes were based on retrospective clinician documentation and patient-reported symptom change rather than validated vertigo scales, which limits comparability and introduces subjective bias. Patients were excluded if they were found to have retrocochlear pathology (n=1), had an anacoustic ear (n=1), or had incomplete pre- or post-intervention audiometric results (n=6).

Statistical analysis

ITS technique

Patients were anaesthetised with either 10% xylocaine or 5% EMLA topically for 30 minutes. All patients received compounded 24 mg/mL intratympanic dexamethasone that was stored in the fridge, removed 30 minutes prior to administration, and warmed up to body temperature. A superior drainage hole was created with a 23 G spinal needle in the posterosuperior quadrant, as a persistent tympanic membrane perforation here would be easier to repair. Each needle was primed to avoid air insufflation into the middle ear and an estimated 0.5–0.8 mL was administered per dose into the posteroinferior tympanic membrane with the patient in a supine position. Post-procedure instructions were to avoid talking, yawning, eating, drinking, and excessive swallowing for 30 minutes. No hair washing, heavy lifting, or nose-blowing was advised for the next 24 hours. Patients would receive between 1 and 3 doses maximum depending on initial response for SSNHL, and as required for MD.


Results

In total, there were 141 intratympanic injections performed in 66 patients between January 2020 and August 2024. The mean patient age was 63±13 years (range: 33–95 years), and 60.6% (40/66) were female. Indications for treatment included MD, SSNHL, and labyrinthitis in cases where systemic steroids were contraindicated or refractory (Table 1). Figure 1 shows a summary of hearing outcomes for all SSNHL and labyrinthitis patients using Siegel’s Criteria.

Table 1

Demographics, clinical characteristics, and outcomes for patients treated with intratympanic steroid injections

Items All SSNHL MD Labyrinthitis
Number of patients 66 30 30 6
Number of injections 141 47 84 10
Sex, M : F 26:40 13:17 11:19 2:4
Mean age (years) 63±13 [33–95] 63±14 [38–85] 65±12 [39–95] 52±15 [34–68]
Systemic steroids (number of patients)
   Yes 30 24 6
   No 7 7 0
Mean time to treatment (days) 46.2±22.9 35.0±20.1
Mean number of injections per patient 2.2±1.8 1.4±0.6 2.7±2.1 1.5±0.7
Mean interval between injections (days) 80.2±142.3 13.5±3.9 99.4±162.0 19.0±7.8
Improvement in vertigo
   Yes 70 63 7
   No 11 8 3
   Not recorded 13 13
Improvement in tinnitus
   Yes 25 7 17 1
   No 27 8 18
   Not recorded 80 32 48 0
Improvement in speech score
   Yes 40 17 18 5
   No 57 29 23 5
   Not recorded 44 1 43
Mean PTA gain (dB) after ITS 14.9±77 18.6±51.1 10.0±89.6 37.5±69.7

Data is presented as n, mean ± SD or mean ± SD [range] unless otherwise specified. Similarly, outcome measures are reported per injection, unless otherwise specified. dB, decibels; F, female; ITS, intratympanic steroid; M, male; MD, Ménière’s disease; PTA, pure-tone average; SD, standard deviation; SSNHL, sudden sensorineural hearing loss.

Figure 1 Distribution of hearing recovery following high-dose (24 mg/mL) ITS for SSNHL and labyrinthitis using Siegel’s Criteria (19). Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; SSNHL, sudden sensorineural hearing loss.

Ménière’s disease (MD) (n=30/66; 84 injections)

Eighty-four injections were performed in 30 patients with MD. Patients received a mean of 2.7±2.1 injections spaced at an average interval of 99.4±162.0 days. Mean improvement in PTA was 10.0±89.6 dB (range: −230 to 235 dB; 95% CI: −9.4 to 29.5; P=0.33) and 75% of patients (n=22) reported subjective improvement in vertigo frequency and severity. One patient remained completely vertigo-free for 31 months after a single injection. There were no long-term complications. Mean follow-up was 99.4±162 days.

SSNHL (n=30/66; 47 injections)

A total of 47 injections were administered to 30 patients with SSNHL (Figure 2). Patients received a mean of 1.4±0.6 injections, with an average interval of 13.5±3.9 days. The mean time to treatment from hearing loss onset was 46.2±22.9 days (range: 3–109 days). Mean PTA gain was 18.6±51.1 dB (range: −135 to 205 dB; 95% CI: 3.7–33.6; P=0.02). Pre-treatment PTA averaged 45.6±21.4 dB and post-treatment PTA averaged 43.9±21.3 dB. Clinically significant improvement was observed in 27 injections (57.4%) using a ≥15 dB threshold. Tables 2,3 show outcomes classified using Modified Siegel’s Criteria. One injection administered 90 days after hearing loss onset demonstrated a 50 dB PTA improvement. Mean follow-up was 46.2±22.9 days. There were no long-term complications observed.

Figure 2 Audiometric threshold outcomes following high-dose ITS therapy for all SSNHL patients classified using Siegel’s Criteria. The majority of injections (57%) had either partial or slight recovery. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; SSNHL, sudden sensorineural hearing loss.

Table 2

Outcomes for SSNHL using Modified Siegel’s Criteria per injection

Grade Audiometric criteria Outcome Injections
1 Final hearing level ≤25 dB PTA Complete recovery 5 [11]
2 More than 15 dB hearing gain and final hearing level 26–45 dB PTA Partial recovery 13 [28]
3 More than 15 dB hearing gain and final hearing level 46–75 dB PTA Slight improvement 11 [23]
4 Less than 15 dB hearing gain or final hearing level 76–90 dB PTA No improvement 16 [34]
5 Final hearing level >90 dB PTA Non-serviceable ear 2 [4]

Data are presented as n [%]. Hearing outcomes classified by Modified Siegel’s Criteria (20). dB, decibel; PTA, pure-tone average; SSNHL, sudden sensorineural hearing loss.

Table 3

Pre- and post-treatment hearing outcomes per injection in SSNHL using Modified Siegel’s Criteria

Pre-treatment hearing grade Modified Siegel’s hearing recovery outcomes
Complete recovery Partial recovery Slight improvement No improvement Non-serviceable ear Total
Primary therapy
   Grade 1 2 [100] 2
   Grade 2 3 [50] 1 [17] 2 [33] 6
   Grade 3 2 [29] 3 [43] 2 [29] 7
Salvage therapy
   Grade 1 3 [60] 2 [40] 5
   Grade 2 1 [8] 6 [46] 1 [8] 5 [38] 13
   Grade 3 2 [20] 4 [40] 4 [40] 10
   Grade 4 1 [100] 1
   Grade 5 1 [33] 2 [67] 3

Data are presented as n [%] or n. Hearing outcomes classified by Modified Siegel’s Criteria (20). Complete recovery defined as post-treatment PTA ≤25 dB; partial recovery as >25 dB gain; slight improvement as 10–25 dB gain; no improvement as <10 dB gain; non-serviceable ear defined as final PTA ≥90 dB. dB, decibel; PTA, pure-tone average; SSNHL, sudden sensorineural hearing loss.

SSNHL with primary therapy ITS (n=7; 15 injections)

Fifteen injections were performed in seven patients who received ITS as single initial therapy (Figures 3,4). The mean time to treatment from hearing loss onset was 44.7±23.2 days (range: 3–90 days). Patients received a mean of 1.7±0.7 injections, with an average interval of 12 days. The overall mean PTA gain was 12.0±28.2 dB (range: −25 to 80 dB; 95% CI: −3.6 to 27.6; P=0.12), which was not statistically significant. Nine out of fifteen (60%) injections demonstrated ≥15 dB improvement in PTA results. No significant correlation was observed between time to treatment and PTA outcome, although only three out of fifteen (20%) injections were delivered within the conventional 28-day treatment window (Figure 5). Pre-treatment PTA averaged 44.0±14.7 dB and post-treatment PTA averaged 43.1±13.7 dB. No complications were reported.

Figure 3 Audiometric threshold outcomes following primary ITS therapy for SSNHL patients using Siegel’s Criteria. Half of injections demonstrated partial or slight recovery, with no cases of complete recovery. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; SSNHL, sudden sensorineural hearing loss.
Figure 4 Pre- and post-treatment PTA following primary ITS therapy for SSNHL using Modified Siegel’s Criteria (20). All patients with pre-treatment hearing grade 1 achieved complete recovery. For pre-treatment hearing grades 2 and 3, 67% and 71% respectively demonstrated clinically significant improvement in PTA. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; PTA, pure-tone average; SSNHL, sudden sensorineural hearing loss.
Figure 5 Relationship between time to treatment and audiometric threshold improvement following primary ITS therapy for SSNHL. No correlation between time to ITS and audiometric improvement was observed (R2=0.0226). Only three out of fifteen injections were performed within 28 days of hearing loss onset. One patient improved 80 dB after an injection administered 41 days after hearing loss onset. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; PTA, pure-tone average; SSNHL, sudden sensorineural hearing loss.

SSNHL with ITS as salvage therapy (post-systemic steroids) (n=23; 32 injections)

Thirty-two injections were performed in 23 people who had received systemic high-dose steroids prior to ITS (Figures 6,7). The mean PTA gain was 21.7±59 dB (range: −135 to 205 dB; 95% CI: 0.4–43.0; P=0.055), with 56% of injections (n=18) achieving ≥15 dB improvement in PTA. The mean number of injections received was 1.3±0.5 (range: 1–3) with a mean interval of 14.9±3.5 days. The mean time to treat from hearing loss onset was 46.8±22.9 days (range: 15–109 days). Only five out of thirty-two injections were performed within 28 days of hearing loss onset. Mean pre-treatment PTA was 46.3±24.1 dB and mean post-treatment PTA was 44.23±24.29 dB. No significant correlation was observed between time to treatment and PTA outcome (Figure 8). No treatment-related complications were observed.

Figure 6 Audiometric threshold outcomes for SSNHL treated with salvage ITS therapy using Siegel’s Criteria. No patients achieved complete recovery. Eleven injections (34%) demonstrated partial recovery, seven (22%) had slight recovery, and fourteen (44%) showed no recovery. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; SSNHL, sudden sensorineural hearing loss.
Figure 7 Pre- and post-treatment PTA following salvage ITS for SSNHL using Modified Siegel’s Criteria (20). Clinically significant recovery was observed in 60%, 61.5%, 60%, and 100% of patients with pre-treatment hearing grades 1, 2, 3, and 4, respectively. Of the non-serviceable ears (grade 5), only one patient (33%) showed improvement. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; PTA, pure-tone average; SSNHL, sudden sensorineural hearing loss.
Figure 8 Relationship between time to treatment and audiometric threshold improvement in patients receiving salvage ITS therapy for SSNHL. No correlation between time to ITS and audiometric improvement was observed (R2=0.0051). Only 5 out of 32 injections were administered within 28 days of hearing loss onset. One patient improved 80 dB after being administered ITS 80 days after onset of hearing loss. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid; PTA, pure-tone average; SSNHL, sudden sensorineural hearing loss.

Labyrinthitis (n=6/66; 10 injections)

Six patients with labyrinthitis received ten injections, with a mean interval of 19±7.8 days (Figure 9). Mean time to treatment from hearing loss onset was 43.7±17.5 days (range: 23–73 days). The average improvement in PTA was 37.5±69.7 dB (range: −45 to 210 dB; 95% CI: −12.4 to 87.4; P=0.12). Mean pre-treatment PTA was 46.8±20.2 dB and post-treatment mean PTA was 42.3±24.7 dB. Five injections (50%) demonstrated ≥15 dB improvement, and one patient met Siegel’s Criteria for complete recovery. Improvement of vertigo was reported in 70% of patients.

Figure 9 Audiometric threshold outcomes following ITS in patients with labyrinthitis using Siegel’s Criteria. Half of injections (50%) achieved recovery. Unless otherwise specified, outcome measures are reported per injection. dB, decibel; ITS, intratympanic steroid.

Summary table of hearing outcomes

A summary of audiometric hearing outcomes for SSNHL, MD, and labyrinthitis patients can be found in Table 4. Data includes SD and 95% CI.

Table 4

Summary of hearing outcomes for SSNHL, MD, and labyrinthitis following high-dose intratympanic dexamethasone (24 mg/mL)

Subgroup n PTA gain (dB) 95% CI (dB) P value
SSNHL
   All 47 18.6±51.1 3.7 to 33.6 0.02*
   Primary 15 12.0±28.2 −3.6 to 27.6 0.12
   Salvage 32 21.7±59.0 0.4 to 43.0 0.055
MD 84 10.1±89.6 −9.4 to 29.5 0.33
Labyrinthitis 10 37.5±69.7 −12.4 to 87.4 0.12

Data is presented as mean ± SD unless otherwise specified. *, P<0.05. PTA gain was calculated as post-treatment minus pre-treatment threshold sums, such that positive values represent hearing improvement. Statistical significance assessed using two-tailed t-test with α=0.05. CI, confidence interval; dB, decibel; MD, Ménière’s disease; PTA, pure-tone average; SD, standard deviation; SSNHL, sudden sensorineural hearing loss.

Adverse effects

There were no long-term complications, such as persistent tympanic membrane perforations, recorded. All patients tolerated the procedure well with few experiencing transient vertigo, pain, or bleeding.


Discussion

Summary of findings

This study evaluated outcomes of high-dose intratympanic dexamethasone (24 mg/mL) for SSNHL, labyrinthitis and MD in a regional clinical setting. The intervention was well tolerated overall with no long-term adverse effects. In SSNHL, approximately half of patients (57.4%) achieved clinically significant hearing recovery (defined as ≥15 dB), although mean improvement was modest at 18.6 dB. The greatest gains were observed in patients receiving ITS as salvage therapy following systemic steroids with 56% improving ≥15 dB. These outcomes fall within the range reported in prior studies of intratympanic dexamethasone. Timing of treatment has consistently been identified as one of the strongest predictors of recovery, with earlier intervention associated with improved outcomes (24). The mean time to treatment in our cohort was 46 days, which exceeds the 6-week salvage therapy window recommended by AAO-HNS guidelines (3). Despite this delayed presentation, over half of patients achieved clinically significant hearing improvement, suggesting that salvage intratympanic therapy could provide benefit beyond the conventional treatment window. Primary ITS therapy demonstrated smaller, clinically insignificant gains with a mean PTA improvement of 12 dB (P=0.12). This finding aligns with prior reports suggesting that ITS alone have limited efficacy compared to placebo (9). Similarly, mean time to treatment for this cohort was 44.7 days, with most receiving delayed intervention. In MD, 75% of patients reported sustained vertigo control with three-monthly ITS injections, with one patient remaining symptom-free for up to 31 months. In labyrinthitis, mean PTA improved by 37.5 dB but was not statistically significant.

Definition of recovery

Interpretation of results is complicated by the lack of a universally agreed definition of recovery in SSNHL. Siegel’s Criteria is the most frequently used system to show hearing outcomes and is used in our study (19). The Modified Siegel’s Criteria enhances prognostic assessment by incorporating baseline hearing severity and distinguishing between ears unlikely to benefit from hearing amplification (20); however, it is far less widely used and validated than the original. The Gardner-Robertson (G-R) classification is a well-established functional hearing scale (25) that helps to better categorise serviceable hearing; however, it could not be used in our study due to incomplete word recognition scores. Criteria for clinically significant improvement can vary from a PTA gain of more than 10–30 dB (26-28); with others classifying partial recovery as between 21% and 90% recovery (29) or at least 50% improvement compared to pre-treatment PTA total scores (30). At the International Federation of Otorhinolaryngological Societies (IFOS) 2017 Ear, Nose, and Throat World Congress panellists suggested that any PTA change exceeding 10 dB could be considered as significant (31). Additionally, patient acceptability of meaningful improvement does not necessarily align with audiometric results. Future standardisation of outcome measures will help to analyse efficacy of ITS treatment.

Timing of treatment

Spontaneous recovery from SSNHL ranges between 32% and 65% (32), with most occurring within the first two weeks. Concurrently, steroids are considered to have the greatest benefit when administered within the first two weeks of onset (15). In this cohort, all but two injections were administered more than 14 days after symptom onset with clinically significant improvement (≥15 dB) in 57.4% of injections. The substantially delayed treatment interval (mean 46 days) in our cohort likely contributed to the modest mean PTA improvement observed, but highlights the potential role of salvage ITS beyond the conventional window. An improvement of 50 dB was seen in one injection that was administered three months after onset of hearing loss. There was no significant relationship between timing to treatment and PTA outcomes in our patients with delayed treatment. In the absence of a control group, it is not possible to establish a causative relationship between ITS and clinical outcomes. Importantly, the predominance of delayed presentations (>4 weeks) in this cohort underscores ongoing challenges of timely recognition and referral of SSNHL as an otological emergency. This reflects a need for continued education among primary care providers regarding urgency of early treatment, as well as broadening access to otolaryngologists willing to offer ITS in a timely manner.

Prognostic factors

Several prognostic factors that influence recovery in SSNHL are described in the literature. Favourable prognostic factors include: earlier timing of treatment within 14 days, milder initial hearing loss, upward-sloping audiograms, absence of vertigo, younger age. Poor prognostic factors include: older age, severity of hearing loss, downward-sloping or flat audiograms, presence of tinnitus or vertigo (33). A recent study also identified cardiovascular disease as a predictor of complete recovery (34). Our cohort was not stratified by these parameters, limiting data interpretation.

Comparison with existing literature

Recovery rates for ITS have varied as much as 0–100% and diverse criteria for improvement have been used (8). In prior studies evaluating high-dose ITS in SSNHL, clinically significant improvement rates of 27–53% have been reported, with mean PTA gains between 15 and 30 dB (8,14,35). The outcomes observed in our SSNHL cohort (57.4% recovery, mean PTA improvement 18.6 dB) are therefore comparable. Haynes et al. found a mean gain of 15 dB and a 27.5% (n=11) recovery rate with high-dose intratympanic dexamethasone (24 mg/mL) for SSNHL using a clinically significant criteria of ≥20 dB (8). Alexander et al. demonstrated superior outcomes with high-dose 24 mg/mL intratympanic dexamethasone combined with systemic steroids, when compared to low-dose 10 mg/mL in a retrospective case series of 37 adults with SSNHL. Clinically significant recovery (≥30 dB improvement) occurred in 53% of patients treated with 24 mg/mL intratympanic dexamethasone with a mean PTA improvement of 28.7 dB; compared to only 17% treated with low-dose 10 mg/mL dexamethasone (14). Additionally, Kakehata et al. demonstrated >10 dB PTA improvement in 58% of patients receiving ITS as salvage therapy (36), which concurs with our salvage cohort recovery rate of 56% improving ≥15 dB. Despite differences in outcome definitions between studies, the recovery rates are consistent. Wang et al. performed a prospective randomised controlled study which showed a dose-dependent response in 203 patients with SSNHL and a mean time-to-treatment of 7.5 days from onset (37). The control group had 57.4% recovery, low-dose (5 mg/mL) had 62% recovery, medium-dose (10 mg/mL) had 69.1% recovery, and high-dose (20 mg/mL) had 70.6% recovery which were all clinically significant (P<0.05) (37). The most recent Cochrane systematic review of thirty studies (2,133 participants) on ITSs for SSNHL found little to no effect of ITS as a primary therapy, but found low-certainty evidence that ITS when used as salvage therapy improves hearing in five-times as many patients compared to placebo [risk ratio (RR) 5.55, 95% CI: 2.89–10.68; 6 studies; 232 participants; low-certainty], but with only a small effect (9.07 dB gain) on hearing threshold (9). This aligns with our findings that the greatest gains are observed in salvage therapy. In MD, ITS efficacy has been shown to control vertigo in up to 50–90% of refractory cases (39), aligning with our 75% response rate.

Limitations and potential biases

Having a single-centre single-surgeon study limited heterogeneity in technique; however, there are several major limitations to acknowledge in this study. This was a small retrospective study with no control arm. As previously mentioned, prognostic factors for SSNHL were not accounted for in this cohort. While spontaneous recovery remains a potential confounder in SSNHL, the majority of spontaneous recovery occurs within the first two weeks of onset (32,40,41)—prior to the time of treatment and data collection for almost all patients in this study. Vertigo outcomes in MD were based on subjective clinician documentation rather than validated patient-reported outcome measures, which limit the strength and comparability of these findings. Furthermore, the absence of data on lifestyle factors (e.g., diet) and use of concomitant medical therapies (e.g., betahistine), combined with the fluctuating nature of MD, limits the reliability of interpreting data. Outcomes were analysed on a per-injection basis rather than per patient, which may limit direct comparison with studies reporting patient-level outcomes. Several subgroups demonstrated wide variability in PTA outcomes, reflected by large SD values, suggesting skewed distributions and heterogeneity in treatment response.

Clinical recommendations

High-dose 24 mg/mL intratympanic dexamethasone may be considered as salvage or adjunctive therapy in SSNHL, offered up to three times and at two-week intervals, in line with the AAO-HNS guidelines. Our cohort received ITS at an average of 6 weeks after hearing loss onset with clinically significant recovery observed in over half of patients, suggesting ITS may still be considered in selected patients beyond the conventional 28-day treatment window. Additionally, for refractory MD, high-dose ITS may provide sustained vertigo control, with most requiring a quarterly maintenance regimen.


Conclusions

High-dose intratympanic dexamethasone (24 mg/mL) was well tolerated and associated with clinically significant hearing recovery in 57.4% of SSNHL cases, despite the majority receiving delayed treatment. The greatest benefit was seen in salvage therapy after systemic steroids, although gains were modest (21.7 dB). Importantly, these findings suggest ITS may represent a potential therapeutic option beyond the conventional 28-day treatment window. The most meaningful clinical application of high-dose ITS, however, may be in the management of refractory MD, where a quarterly injection regimen provided sustained vertigo control in the majority of patients. Larger prospective controlled studies are required to confirm efficacy, standardise outcome measures, and refine treatment protocols.


Acknowledgments

None.


Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-81/rc

Data Sharing Statement: Available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-81/dss

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Funding: None.

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-81/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. Approval was provided by the institutional ethics board of the Alfred Hospital Ethics Committee (Code: EC00315; Project Number: 58/25 and 434/24) and individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.


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doi: 10.21037/ajo-2025-1-81
Cite this article as: Wong S, Alwis ND. Outcomes for high-dose intratympanic dexamethasone (24 mg/mL): a retrospective single-surgeon cohort study in sudden sensorineural hearing loss, Ménière’s disease, and labyrinthitis. Aust J Otolaryngol 2026;9:33.

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