Intratympanic dexamethasone with hyaluronic acid in the treatment of idiopathic sudden sensorineural hearing loss after failure of intravenous steroid and vasoactive therapy

The purpose of this prospective study was to test whether intratympanic application of dexamethasone/hyaluronic acid improves hearing outcome in patients with pantonal idiopathic sudden sensorineural hearing loss (ISSHL), in patients with sudden deafness or sudden profound SHL and in patients with predominant high-frequency ISSHL who are refractory to intravenous steroid and vasoactive therapy. The study took place in an academic tertiary referral hospital involving 21 patients with pantonal ISSHL, 10 patients with sudden deafness or sudden profound SHL and 9 patients with a high-frequency ISSHL. Intratympanic dexamethasone/hyaluronic acid was administered in the affected ear. Hearing was evaluated by means of standard pure-tone audiometry. The differences between pure-tone hearing thresholds by air conduction before intravenous therapy and before the beginning of the intratympanic therapy, as well as before and after intratympanic therapy, were calculated. Statistical analysis was performed by means of the Wilcoxons test for paired samples. Intratympanic injection of dexamethasone/hyaluronic acid results in a significant global (pantonal) improvement in hearing in patients with pantonal ISSHL. It also effects improvement in hearing at selected frequencies (namely at 1.5 and 3 kHz) in patients with a predominant high-frequency ISSHL and at selected frequencies (namely at 0.5, 0.75 and 1 kHz) in patients with sudden deafness or sudden profound SHL. Neither systemic nor local side effects were observed. Intratympanic administration of dexamethasone/hyaluronic acid provides a safe and efficacious therapeutic option for the treatment of patients with pantonal and high-frequency ISSHL who dont respond to intravenous steroid and vasoactive therapy.Abbreviations dB HL decibel hearing level - (IS)SHL (idiopathic sudden) sensorineural hearing loss - kHz kiloHertz     

Eficacia del corticoide intratimpánico como tratamiento de rescate en sordera súbita neurosensorial idiopática

IntroductionIdiopathic sudden sensorineural hearing loss (ISSHL) is defined as an abrupt hearing loss of at least 30 dB of unknown cause. The hearing response obtained after intratympanic steroid injection as a salvage treatment after a prior failure of initial systemic steroid treatment was analysed.Material and methodAn observational study was performed on 125 cases of ISSHL who were diagnosed from 2006 to 2014. Sixteen achieved complete recovery after one week according to Siegel's criteria. The remaining 109 cases were analysed in two groups: one that received intratympanic corticosteroid salvage therapy (treatment group) and one that did not (control group). The recovery was analysed after 6 months and 2 years of follow-up.ResultsThe difference between each group at baseline were not statistically significant. After systemic treatment for 7 days, PTA in the control group was 53.13 dB and 66.11 dB in the treatment group (P < .01). After 6 months, the mean PTA improvement was 10.84 dB in the treatment group, and 1.13 dB in the control group, a significant difference (P < .0001). Only 10 cases achieved full hearing recovery after intratympanic corticosteroid salvage therapy, none of the patients did so in the control group.ConclusionIntratympanic corticosteroid rescue for ISSHL acheived hearing improvement for the cases with failure of initial systemic corticosteroid treatment. However, this treatment did not provide complete hearing recovery according to Siegel's criteria in most cases.     

Effectiveness of intratympanic dexamethasone for refractory sudden sensorineural hearing loss

The purpose of this study was to investigate the effectiveness of intratympanic steroids in patients with idiopathic sudden sensorineural hearing loss who did not respond to initial systemic steroid therapy. This retrospective study involved 51 patients, who did not respond to systemic steroids as a first-line treatment. Initial systemic steroid therapy consisted of administration of methylprednisolon intravenously (250 mg) at the first day and followed by orally (1 mg/kg) tapering for 14 days. Twenty-one patients accepted intratympanic treatment, and the remaining 30 patients who refused intratympanic treatment were evaluated as the control group. Steroids (dexamethasone drops, 1 mg/mL) were administered through a ventilation tube. Hearing was assessed immediately before treatment and 2 months after treatment. Recovery of hearing was defined as an improvement of >20 dB in the pure tone average. We tested 250, 500, 1,000, 2,000, 4,000, and 8,000 Hz frequencies for the pure tone audiometric evaluation. Statistically Student’s t test, Mann–Whitney U test, Chi-squared and Fisher’s exact tests were used. The pure tone average improved in 47.6 % of the intratympanic group and in 10 % of the control group (p = 0.002), with pure tone average improvements of 19.9 ± 16.5 and 4.76 ± 9.6 dB in the intratympanic and control groups, respectively. When the hearing threshold at each frequency was analyzed, improvements at all frequencies were significantly greater in the intratympanic steroid group when compared with the control group (p < 0.01). Intratympanic steroid administration is an effective therapy for sudden sensorineural hearing loss in patients, who are refractory to primary systemic steroid therapy.     

鼓室内注射治疗难治性突发性耳聋52例

目的 探讨鼓室内注射激素作为难治性突发性耳聋的补救治疗措施的临床疗效。方法 重度及极重度突发性耳聋患者96例,接受常规治疗加全身应用激素2周效果不佳,其中52例接受鼓室注射激素,另外44例拒绝鼓室内注射而继续口服药物治疗。纯音测听法(PTA)检测患者补救治疗前后听力,比较气导听阈(0.5、1.0、2.0、4.0 kHz四个频率气导之平均值),分析两组患者补救治疗前后听力结果。结果 鼓室注射组听力提高10 dB以上的患者16例,有效率为30.8%;而对照组仅有3例,有效率为6.8%。两组听力改善值之间的差异有统计学意义(P<0.01)。结论 鼓室内激素注射对突发性耳聋常规治疗无效的患者有良好的疗效,可以作为一种补救治疗措施。     

Intratympanale Dexamethasongabe

Background

Therapy for idiopathic sudden sensorineural hearing loss is still controversial. Although there are no evidenced-based studies, therapy with systemic steroids is widely accepted as the gold standard. Intratympanic administration of steroids appears to be an alternative or additional method of management without the disadvantage of systemic side effects and, therefore, makes therapy accessible for patients with contraindication for systemic steroids.

Material and methods

This retrospective analysis compares the audiometric results of 25 patients who were treated with standard therapy (prednisolone, hydroxyethyl starch, pentoxyfylline) with 23 patients who additionally received intratympanic steroids (IT group). A total of 4 injections were administered within 10 days. The solution used consisted of 0.3 ml dexamethasone (8 mg/ml) and 0.2 ml hyaluronic acid 0.2%. The pure-tone average (PTA) was evaluated prior to and 3 months after treatment.

Results

The PTA 3 months after treatment showed an improvement of 48 dB in the IT group and 38 dB in the standard treatment group. The IT group achieved better recovery with an average PTA improvement of 68% compared to the standard treatment group with an average improvement of 59%. Neither result reached significance.

Conclusion

Combination therapy with intratympanic steroids showed a tendency for better hearing results without serious side effects. However, because current evidence is not adequate, randomized placebo-controlled multicenter studies are needed.     

Prognostic factors of profound idiopathic sudden sensorineural hearing loss

Profound idiopathic sudden sensorineural hearing loss is thought to have a poor prognosis, but few studies have focused on this condition. We aimed to assess the impact of patient factors, audiologic parameters, and salvage intratympanic steroid injection therapy on the prognosis of profound idiopathic sudden sensorineural hearing loss. The demographic, clinical, and audiologic data, degree of hearing recovery, and efficacy of intratympanic steroid injection therapy in 576 patients with profound idiopathic sudden sensorineural hearing loss (mean age 56.2 ± 14.9 years) who had been admitted at four tertiary referral centers between 2000 and 2011 were retrospectively reviewed. The mean hearing level at the initial presentation was 108.1 ± 9.5 dB. Many patients experienced vertigo (52.1 %) and tinnitus (77.4 %). At the 2-month follow-up, 172 (29.8 %) patients showed some degree of hearing recovery, but only 21 (3.6 %) patients recovered normal hearing. Further, the 116 patients who had received salvage intratympanic steroid injections showed a better audiologic outcome (improvement, 26.1 ± 24.3 vs. 15.7 ± 22.1 dB; P = 0.000) than those who had not (n = 429). In conclusion, a higher degree of hearing loss at the initial presentation indicates a poorer prognosis. Salvage intratympanic steroid injection therapy may improve the hearing of patients with profound idiopathic sudden sensorineural hearing loss after the failure of systemic steroid therapy.     

Idiopathic sudden sensorineural hearing loss: Effectiveness of salvage treatment with low-dose intratympanic dexamethasone

Objectives:To evaluate hearing outcome of salvage treatment with intratympanic steroids(ITS)in idiopathic sudden sensorineural hearing loss(ISSNHL)refractory to initial systemic steroid(SS)therapy.Material and methods:A retrospective medical chart review was conducted on 54 consecutive patients with ISSNHL refractory to SS.Salvage treatment with a low dose intratympanic dexamethasone(4 mg/ml)was offered after one week of primary treatment.Patients were divided into two groups:25 patients accepted ITS(treatment group)and 29 patients did not undergo additional treatment(control group).A pure tone average(PTA)gain of at least 10 dB was considered hearing improvement.Results:Hearing improvement rate was higher in ITS group compared to control group(40%vs.13.8%,p=0.035).A mean PTA improvement of 8.6±9.8 dB was observed in the ITS group and,whereas the control group had an average hearing gain of 0.7±2 dB(p<0.001).Audiometric analysis revealed a significant hearing gain in ITS group at all tested frequencies compared to control group(p<0.05).Analysis of the selected variables,identified intratympanic steroid treatment as the only independent prognostic factor for hearing improvement(OR=4.2,95%CI:1.1e15.7;p=0.04).Conclusion:Intratympanic low dose dexamethasone is effective in patients with incomplete hearing recovery after primary systemic steroid treatment.     

Intratympanic dexamethasone and hyaluronic acid in patients with low-frequency and Ménière's-associated sudden sensorineural hearing loss.

BACKGROUND: Steroids are widely used for the treatment of cochleovestibular disorders. Direct steroid application in the middle ear cavity, when combined with a round window membrane permeability-modulating substance, increases the level of the steroid reaching the target cells. We measured hearing in patients with idiopathic isolated low-frequency sensorineural hearing loss and in patients with sudden sensorineural hearing loss and a history of Ménière's disease. Contradictory reports about effectiveness of intratympanic steroid therapy on vertigo control and hearing improvement in patients with Ménière's disease exist in the literature. METHODS: Eighteen patients with isolated low-frequency idiopathic sudden sensorineural hearing loss and 21 patients with sudden sensorineural hearing loss and a history of Ménière's disease were prospectively evaluated. The acute effect of the intratympanic application of dexamethasone with hyaluronic acid on hearing outcome after failure of an initial standard treatment with intravenous steroid and vasoactive substances was assessed. Evaluation was based on standard pure-tone audiometry findings. RESULTS: After intratympanic injection of dexamethasone and hyaluronic acid, 14 of the 18 patients with isolated low-frequency sensorineural hearing loss showed a significant improvement in hearing. After intratympanic therapy, 15 patients with a previous history of Ménière's disease and idiopathic isolated low-frequency sensorineural hearing loss showed an improvement in hearing on pure-tone audiometry, four remained unchanged, and two showed a tendency toward a slight deterioration. CONCLUSION: Intratympanic combined dexamethasone/hyaluronic acid application provides a reliable and safe therapeutic option for improvement of hearing in patients with isolated low-frequency idiopathic sudden sensorineural hearing loss or sensorineural hearing loss resulting from Ménière's disease who have failed intravenous steroid and vasoactive treatments.     

Intratympanic steroids as a salvage therapy for severe to profound idiopathic sudden sensorineural hearing loss

Abstract

Background: Idiopathic sudden sensorineural hearing loss (ISSNHL) is defined as a decline in hearing affecting three or more frequencies by 30?dB

Objective: The aim of this study was to evaluate the results of intratympanic steroids as a salvage treatment for severe ISSNHL.

Materials and methods: A regimen of three IT steroid injections was offered to patients who failed a 7-days intravenous steroid treatment. Eighty-four patients underwent IT salvage treatment (IT group). Their outcomes were compared with those of 255 patients with severe ISSNHL who received the same intravenous steroid regimen without salvage IT steroid therapy (Control group).

Results: 56% of the patients in the IT group had a hearing improvement of >15?dB after one month. The average hearing improvements were 26.5?±?28?dB and 27.9?±?24?dB in the IT group and the Control group, respectively (p?=?.67). However, patients with a type E audiogram pattern (total deafness), displayed a substantial hearing gain.

Conclusion: Intratympanic steroids failed to show a global auditory benefit as a salvage treatment in patients with severe ISSNHL.

Significance: Our data suggest that a salvage treatment with intratympanic dexamethasone may be offered to patients with total deafness for whom the first systemic treatment has failed.     

Intratympanic corticosteroids for sudden idiopathic sensorineural hearing loss.

OBJECTIVE: To determine whether instillation of intratympanic steroids is effective in the treatment of sudden idiopathic sensorineural hearing loss. METHODS: A retrospective chart review of all patients who underwent intratympanic steroid treatment (methylprednisolone and/or dexamethasone) between 1996 and 2002 at a tertiary care university otology clinic. Thirty-three patients were identified, of which 26 met inclusion criteria for having an idiopathic hearing loss. Pretreatment and posttreatment pure-tone audiograms and speech discrimination scores were compared. RESULTS: Overall, there was a 27.2 +/- 5.7 dB improvement in the pure-tone thresholds and a 25.4 +/- 6.2% improvement in speech discrimination scores. Those treated within 10 days of onset had a statistically significant better outcome than those treated after 10 days. No adverse reactions or complications were reported. CONCLUSION: Instillation of intratympanic steroids represents a safe and potentially effective treatment of sudden idiopathic sensorineural hearing loss.     

Tympanoskopie mit Abschottung der Rundfenstermembran beim idiopathischen Hörsturz

Background

The pathogenesis of idiopathic sudden sensorineural hearing loss (ISSHL) still remains unclear. This retrospective study was performed to evaluate the effectiveness of tympanotomy and sealing of the round window membrane after unilateral idiopathic sudden sensorineural hearing loss.

Methods

A total of 74 patients with idiopathic sudden sensorineural hearing loss were treated with antiphlogistic-rheologic infusion therapy according to Stennert (steroids and pentoxyphylline). In addition, all patients underwent exploratory tympanotomy and sealing of the round window membrane. Pure tone audiometry was performed pre- and postinterventionally.

Results

The average hearing loss (four pure tone average) of all patients was 58.9 dB pre-, and 46 dB postinterventionally, which is an average improvement of 12.9 dB. Patients with hearing loss of more than 60% improved significantly compared to patients with hearing loss less than 60% (33.9% vs. +3.3%). Sealing of the round window membrane was found to be more effective when performed within 8 days after ISSHL. A membrane rupture did not lead to better therapy results. No significant correlation was found between therapy outcome and other clinical symptoms.

Conclusion

Sealing of the window membrane shows equal results to conservative methods. If patients with hearing loss of more than 60% have more benefit in tympanotomy with sealing of the window membrane than patients with less hearing loss—as shown as in this study—has to be proved in randomized examinations. Intraoperatively found ruptures of the round window membrane had no significant effect on the therapy outcome.     

Intratympanic dexamethasone perfusion versus injection for treatment of refractory sudden sensorineural hearing loss

Intratympanic steroid treatment for the sudden sensorineural hearing loss (SSNHL) has a long history and many techniques have been developed. The efficacies are varied in different studies owing to different criteria, steroid type and dose, delivery methods, or absence of comparison groups. Recently, animal experiments suggested that continuous delivery systems produce the higher inner ear drug concentrations than other ways. This study was aimed at evaluating the efficacies of intratympanic dexamethasone perfusion versus injection for treatment of refractory sudden sensorineural hearing loss (RSSNHL). A total of 136 patients were enrolled in this nonrandomized, prospective, controlled study. Thirty-two patients were treated with continuous intratympanic dexamethasone perfusion via round window microcatheter by an electronic pump at a rate of 10 μl/min twice daily for 7 days and 34 patients underwent intratympanic dexamethasone injection of the same dosage. Seventy patients who refused to undertake further treatment were selected as a control group. Pure-tone audiometry results were obtained before and after treatments. Minimum follow-up time from the last treatment was 1 month. There were no serious adverse events in the treatment groups. Hearing improvement rate (HIR) of SSNHL in perfusion group was 40.6 %, which was significantly higher than in the injection and control groups (20.6 and 7.7 %, respectively). HIR had no relation with sex, age, and associated symptoms. Results indicated that intratympanic dexamethasone perfusion by external electronic pump with gelatin sponge placement in round window niche is an efficacious and safe method for the treatment of RSSNHL, showing superiority to simple injection through the drum.     

Intratympanic dexamethasone for sudden sensorineural hearing loss after failure of systemic therapy

OBJECTIVE: Intratympanic steroids are increasingly used in the treatment of inner ear disorders, especially in patients with sudden sensorineural hearing loss (SNHL) who have failed systemic therapy. We reviewed our experience with intratympanic steroids in the treatment of patients with sudden SNHL to determine overall success, morbidity, and prognostic factors. HYPOTHESIS: Intratympanic steroids have minimal morbidity and the potential to have a positive effect on hearing recovery in patients with sudden SNHL who have failed systemic therapy. STUDY DESIGN: The authors conducted a retrospective review. METHODS: Patients presenting with sudden SNHL defined as a rapid decline in hearing over 3 days or less affecting 3 or more frequencies by 30 dB or greater who underwent intratympanic steroids therapy (24 mg/mL dexamethasone) were reviewed. Excluded were patients with Meniere disease, retrocochlear disease, autoimmune HL, trauma, fluctuating HL, radiation-induced HL, noise-induced HL, or any other identifiable etiology for sudden HL. Patients who showed signs of fluctuation of hearing after injection were excluded. Pretreatment and posttreatment audiometric evaluations including pure-tone average (PTA) and speech reception threshold (SRT) were analyzed. Patient variables as they related to recovery were studied and included patient age, time to onset of therapy, status of the contralateral ear, presence of diabetes, severity of HL, and presence of associated symptoms (tinnitus, vertigo). A 20-dB gain in PTA or a 20% improvement in SDS was considered significant. RESULTS:: Forty patients fit the criteria for inclusion in the study. The mean age of the patients was 54.8 years with a range from 17 to 84 years of age. Overall, 40% (n = 16) showed any improvement in PTA or SDS. Fourteen (35%) men and 26 (65%) women were included. Using the criteria of 20-dB improvement in PTA or 20% improvement in SDS for success, 27.5% (n = 11) showed improvement. The mean number of days from onset of symptoms to intratympanic therapy was 40 days with a range of 7 days to 310 days. A statistically significant difference was noted in those patients who received earlier injection (P = .0008, rank sum test). No patient receiving intratympanic dexamethasone after 36 days recovered hearing using 20-dB PTA decrease or a 20% increase in discrimination as criteria for recovery. Twelve percent (n = 5) of patients in the study had diabetes with 20% recovering after intratympanic dexamethasone (not significantly different from nondiabetics at 28.6%, Fisher exact test, P = 1.0). Comparison to other studies that used differing steroid type, concentration, dosing schedule, inclusion criteria, and criteria for success revealed, in many instances, a similar overall recovery rate. CONCLUSIONS: Difficulty in proving efficacy of a single modality is present in all studies on SNHL secondary to multiple treatment protocols, variable rates of recovery, and a high rate of spontaneous recovery. Forty percent of patients showed some improvement in SDS or PTA after treatment failure. When criteria of 20-dB PTA or 20% is considered to define improvement, the recovery rate was 27.5%. Modest improvement is seen with the current protocol of a single intratympanic steroid injection of 24 mg/mL dexamethasone in patients who failed systemic therapy. Dramatic hearing recovery in treatment failures was rarely encountered. No patient showed significant benefit from intratympanic steroids after 36 days when using this protocol for idiopathic sudden SNHL. If patients injected after 6 weeks are excluded from the study, the improvement rate increases from 26.9% to 39.3%. Earlier intratympanic injection had a significant impact on hearing recovery, although with any therapeutic intervention for sudden SNHL, early success may be attributed to natural history. If we further exclude seven patients treated with intratympanic steroids within 2 weeks of the onset of symptoms (i.e., study only those patients treated with intratympanic dexamethasone between 2 and 6 weeks after onset of symptoms), still, 26% improved by 20 dB or 20% SDS. The recovery rates after initial systemic failure are higher than would be expected in this treatment failure group given our control group (9.1%) and literature review. These findings indicate a positive effect from steroid perfusion in this patient population.     

A comparison between systemic and intratympanic steroid therapies as initial therapy for idiopathic sudden sensorineural hearing loss: a meta-analysis

Conclusions: Intratympanic steroid (ITS) treatment groups exhibited better outcomes in PTA improvement and recovery rate than systemic steroid therapy (SST) groups. Whether initial hearing loss severity would influence the PTA improvement and recovery rate still requires further research.

Objective: This article was aimed at evaluating whether intratympanic steroid (ITS) treatment would provide benefits over systemic steroid therapy (SST) as initial therapy in patients with idiopathic sudden sensorineural hearing loss (ISSHL). A meta-analysis was carried out based on published RCTs that included the hearing outcomes of ITS treatment and SST in ISSHL as initial therapy. Both PTA differences and recovery rate were analyzed.

Methods: The literature search was based on the online database including Pubmed, Embase, and Cochrane trails, which completed in July 2016. This study extracted the relevant data following the selection criteria. Mean difference (MD) of PTA differences and Odds ratio (OR) of recovery rate were calculated within 95% confidence intervals.

Results: Six eligible articles were reviewed. The pooled MDs of PTA differences was 3.42 (95% CI?=?0.17–6.67, p?=?.04) and the pooled ORs of recovery rate was 2.05 (95% CI?=?1.38–3.03, p?=?.0003), which indicated that ITS treatment yielded better PTA improvement than SST. Sub-group analyses based on the initial hearing loss were also conducted; however, the difference was insignificant according to our analysis results (p?=?.82 for PTA improvement and p?=?.26 for recovery rate).     

地塞米松鼓室内注射补救治疗突发性聋

目的 观察地塞米松鼓室内注射对经过常规治疗没有痊愈或无效的突发性聋的疗效.方法选择门诊经过常规治疗没有痊愈的突发性聋患者45耳,随机分成2组,实验组21耳,地塞米松经鼓膜穿刺鼓室内注射2毫克/次,2次（一周）一个疗程;对照组24耳,给谷维素及复合维生素B口服,用药一周.观察治疗前后纯音听阈及耳呜、耳闷感的变化情况.结果纯音测听结果显示实验组6耳有效（6/21）,对照组1耳有效（1/24）,两组比较差异有统计学意义（P＜0.05）;耳呜改善实验组有5耳（5/15）,对照组1耳（1/19）,两组比较差异有统计学意义（P＜0.05）;耳闷感改善实验组有3耳（3/11）,对照组1耳（1/13）,两组比较差异无统计学意义（P＞0.05）.结论地塞米松鼓室内注射可以改善常规治疗没有痊愈的突发性聋患者的听力及耳鸣症状.     

Hyperbaric oxygen and steroid therapy for idiopathic sudden sensorineural hearing loss

In our controlled retrospective analysis of medical records in tertiary care academic medical center, we aimed to investigate the therapeutic effects of hyperbaric oxygen (HBO) therapy combined with steroid administration for idiopathic sudden sensorineural hearing loss (ISSNHL) in comparison with that of steroid administration alone. Our subjects were 130 consecutive inpatients with ISSNHL (hearing levels ≥40 dB; time from the onset of hearing loss to the start of treatment ≤30 days). Sixty-seven patients underwent HBO plus steroid therapy (HBO group), and 63 were given steroids alone (steroid group). Hearing recovery was evaluated by grade assessment and by the improvement in hearing compared to that in the unaffected contralateral ear. The cure rate and hearing improvement rate were not statistically different between the two groups; however, the recovery rate was significantly higher in the HBO group than in the steroid group (59.7% vs. 39.7%; P < 0.05). With regard to patients with initial hearing levels of ≥80 dB, the hearing improvement rate was significantly higher in the HBO group than in the steroid group (51.1 ± 7.0% vs. 27.1 ± 7.8%; P < 0.05), while in patients whose initial hearing levels were <80 dB, hearing outcomes were not statistically different between the two groups. In both the HBO and steroid groups, patients with initial hearing levels of <80 dB showed a better hearing improvement rate than those with initial hearing levels of ≥80 dB. In conclusion HBO therapy shows a significant additional effect in combination with steroid therapy for ISSNHL, particularly in patients with severe hearing loss.     

Comparison of pure-tone audiometry analysis in sudden hearing loss studies: lack of agreement for different outcome measures.

HYPOTHESIS: Different methods of pure-tone audiometry analysis in sudden hearing loss studies show a lack of agreement with respect to outcome, and the choice of outcome measure influences sample size calculation. BACKGROUND: There is an increasing number of clinical reports on the treatment of sudden hearing loss. For comparison of efficacy between different therapies and for meta-analysis, it is important to consider the outcome measures in different studies. Statistical analysis for comparison of different outcome measures is used in this study. MATERIALS AND METHODS: Controlled clinical studies on the therapy for idiopathic sudden sensorineural hearing loss (ISSHL) were reviewed with respect to their choice of measurement method for the primary endpoint based on pure-tone audiometry. A selection of outcome measures, including different frequencies evaluated, absolute and relative hearing improvement, and different criteria for success, were compared by applying them on the same patient population treated for ISSHL. Agreement between different clinical outcome measures was assessed by using a method described by Bland and Altman. Based on the change in hearing level in the patient population, sample sizes were calculated for various outcome measures and for different criteria of hearing improvement. RESULTS: In 52 controlled studies on the systemic treatment of ISSHL, more than 40 different outcome measures for the primary endpoint were identified. Comparison of measurement methods showed no acceptable agreement between most absolute and relative measures of hearing improvement and between endpoints on the basis of different criteria of success. The differences in outcome in the treatment of ISSHL were more affected by the definition of success than by frequencies included in the pure-tone average. Estimated sample sizes for controlled clinical trials varied substantially with the choice of outcome measure. CONCLUSION: The lack of an acceptable agreement between most measurement methods assessed in this report prevents a meaningful comparison of published clinical studies on ISSHL. For comparison of efficacy between different treatments in ISSHL and for the planning of controlled clinical trials, it is necessary to agree on standardized outcome measures, including the frequencies averaged and the criteria of success.     

Intratympanic steroids for idiopathic sudden sensorineural hearing loss

OBJECTIVES: We undertook to evaluate the effectiveness of intratympanic (IT) steroid injections for treating idiopathic sudden sensorineural hearing loss (ISSHL) by performing a retrospective case series study in a private otology practice. METHODS: A total of 21 eligible patients with ISSHL were included. We defined ISSHL as a hearing loss of 20 dB or more at at least 3 consecutive audiometric frequencies that develops within 72 hours or less and cannot be attributed to any commonly identifiable cause of sudden hearing loss. Three IT injections of 0.4 mL of 62.5 mg/mL methylprednisolone solution were administered 1 week apart. The end point for the study was a clinically significant change in audiometric values, with a positive response determined to be a 10-dB or greater improvement in the 4-tone pure tone average and/ or a 15% or greater improvement in the word discrimination score. Audiometric data were recorded just before therapy and 1 week after the last IT treatment. The potentially confounding variables recorded included age, sex, "prompt treatment" (defined as treatment within 14 days from onset), concurrent or prior treatment with oral steroids, and severity of hearing loss. RESULTS: The overall response rate to the IT steroid protocol was 67% (14 of 21 patients), with a 95% confidence interval of 43% to 85%. Backward stepwise logistic regression identified "prompt treatment" as the only variable that significantly affected the outcome. The response rate of the "prompt treatment" cohort was 91% (10 of 11 patients), with a 95% confidence interval of 59% to 100%. CONCLUSIONS: These findings support the use of IT steroids as an early intervention in the treatment of ISSHL.     

Modified intratympanic treatment for idiopathic sudden sensorineural hearing loss

Steroids are the only proven drugs in the treatment for idiopathic sudden sensorineural hearing loss. In the recent studies, it has been suggested that, steroids delivered through the intratympanic route obtained higher perilymph levels, resulting in better hearing outcomes. The purpose of this study is to compare the hearing outcomes of the two routes of steroid treatment: intratympanic route and systemic route. In this prospective study, 60 consecutive patients with idiopathic sensorineural hearing loss treated between January 2005 and September 2008 were enrolled: 29 were in the intratympanic steroid group (ITSG) and 31 were in the systemic steroid group (SSG). In the ITSG, 5 intratympanic injections of dexamethasone were performed with the dose of 4 mg/ml, consecutively. Oral methylprednisolone was given at the dose of 1 mg/kg, tapered every 2 days and stopped at 10 days, in the SSG. The pure tone averages (PTA), speech discrimination scores (SDS) and the percentage of the patients who made an improvement more than 10 dB were analyzed on the tenth day and 2 months after the treatment statistically. The improvement in PTA on tenth day and second month after treatment was 31.38 and 37.55 dB, in the ITSG and 19.35 and 20.68 dB in the SSG, respectively. The improvement in SDS in the same time period was 35.24 and 37.52% in the ITSG and 20.13 and 19.61% in the SSG, respectively. Also, 25 of the 29 patients (86.2%) in the ITSG and 16 of the 31 patients (51.6%) in the SSG made an improvement more than 10 dB on PTA in the second month control. Intratympanic steroids gave better hearing results than systemic steroids with no systemic side effects. Studies with more sample sizes will identify the best steroid for injection, application time, frequency and dose.     

Idiopathic sudden sensorineural hearing loss in children

OBJECTIVE: Although idiopathic sudden sensorineural hearing loss (ISSHL) is a frequent disease in adults, less is known about incidence and treatment of ISSHL in children. METHOD: A retrospective chart analysis was performed to evaluate the frequency of ISSHL in children aged under 18 years between 2000 and 2003, who were treated in our department. Children received prednisolone intravenously at an initial dose of 3mg/kg bodyweight. Prednisolone dose was reduced to half every second day. The medication was given for a maximum of 14 days or finished 2 days after the hearing normalized in pure-tone audiometry. The follow-up was continued between 3 and 14 months. RESULTS: The complete recovery rate was 57%, and the partial recovery was 36%. Initial hearing loss of 50dB and more was predictive for poor outcome in children (p=0.028). Presence of tinnitus was without relevance for the outcome. The incidence of ISSHL in the local area of about 250,000 inhabitants was 1/10,000 in children. CONCLUSION: ISSHL seems to be a less frequent disease in children than in adults. Severe initial hearing loss is coupled with poor outcome. Under treatment with prednisolone hearing improvement was found in 13 of 14 patients.