Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy

Plontke, Stefan K.; Löwenheim, Hubert; Mertens, Jürgen; Engel, Corinna; Meisner, Christoph; Weidner, Andy; Zimmermann, Rainer; Preyer, S; Koitschev, Assen; Zenner, Hans‐Peter

doi:10.1002/lary.20074

Cited by 147 publications

(135 citation statements)

References 57 publications

(76 reference statements)

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“…IT-steroid application leads to higher perilymph levels of steroids than systemic administration, at least in guinea pigs; however, IT steroids are not absorbed into the systemic circulation (Chandrasekhar et al, 2000). Initially, they were utilized mainly in the context of patients with contraindications to systemic steroid therapy and patients who have failed systemic steroid administration (Dallan et al, 2010;Ho, Lin, Shu, Yang, & Tsai, 2004;Hong, Park, & Lee, 2009;Plontke et al, 2009;She et al, 2010;Slattery, Fisher, Iqbal, Friedman, & Liu, 2005). Rausch and colleagues have recently shown that IT application of corticosteroids is not inferior to systemic steroids for idiopathic SSNHL with thresholds less than 70 dB HL (Rauch, Reda, & Halpin, 2010).…”

Section: Treatmentmentioning

confidence: 99%

Sudden Sensorineural Hearing Loss

Kuhn

Heman‐Ackah

Shaikh

et al. 2011

Trends in Amplification

345

178

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Sudden sensorineural hearing loss (SSNHL) is commonly encountered in audiologic and otolaryngologic practice. SSNHL is most commonly defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring within a 72-hr period. Although the differential for SSNHL is vast, for the majority of patients an etiologic factor is not identified. Treatment for SSNHL of known etiology is directed toward that agent, with poor hearing outcomes characteristic for discoverable etiologies that cause inner ear hair cell loss. Steroid therapy is the current mainstay of treatment of idiopathic SSNHL in the United States. The prognosis for hearing recovery for idiopathic SSNHL is dependent on a number of factors including the severity of hearing loss, age, presence of vertigo, and shape of the audiogram.

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Section: Treatmentmentioning

confidence: 99%

Sudden Sensorineural Hearing Loss

Kuhn

Heman‐Ackah

Shaikh

et al. 2011

Trends in Amplification

345

178

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“…Several others studies have supported IT DEX as salvage therapy, while other lack sufficient evidence of success [9,12,17,19,[20][21][22][23] . Among the factors that could influence hearing outcome, time from onset of HL to the baseline visit was found to be statistically significant (p=0.030).…”

Section: Discussionmentioning

confidence: 99%

The Role of High Dose Intratympanic Dexamethasone as Salvage Therapy for Idiopathic Sudden Sensorineural Hearing Loss

Kordiš

Battelino

2017

Int Adv Otol

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OBJECTIVE:The aim of this study was to assess the efficacy of a single high dose intratympanic (IT) dexamethasone (DEX) as salvage therapy for idiopathic sudden sensorineural hearing loss (ISSNHL) after unsuccessful treatment with oral corticosteroid (CS). MATERIALS and METHODS:This was a prospective open-label study of 59 patients treated with IT DEX after systemic CS therapy has failed. All patients received high dose (24 mg/mL) IT DEX in a single injection through myringotomy. RESULTS:Of the 59 patients, 40.7% showed improvement in their mean pure tone average (PTA) with IT DEX (p=0.005). The difference in the mean PTA after oral CS treatment only from baseline was not statistically significant (p=0.074). The time from onset of hearing loss to the start of therapy was significantly associated with the outcome (p=0.03). CONCLUSION:We determined that high dose IT DEX as salvage therapy was beneficial when the primary treatment with oral CS had failed. An early start of the treatment significantly influenced the improvement of hearing.

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“…Intratympanic steroid injection can be applied as the primary treatment or as a salvage therapy. 8 It especially appears as an effective method when applied as a salvage therapy in patients with SHL, when systemic therapy has failed. 7,[9][10][11][12][13][14][15][16] In this study, we aimed to determine the efficacy of intratympanic methyl prednisolone (IT-MP) therapy in SHL patients who failed after systemic treatment.…”

Section: Intratympanic Methyl Prednisolone Salvage Therapy For Suddenmentioning

confidence: 99%

Intratympanic Methyl Prednisolone Salvage Therapy for Sudden Hearing Loss

Hıdır¹,

Genç²,

Durmaz³

et al. 2012

Turkiye Klinikleri J Med Sci

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A AB BS ST TR RA AC CT T O Ob bj je ec ct ti iv ve e: : The aim of the study was to determine effectiveness of intratympanic methyl prednisolone injection as a salvage therapy for sudden sensorineural hearing loss in patients who did not have complete recovery with systemic treatment. M Ma at te er ri ia al l a an nd d M Me et th ho od ds s: Sixteen patients with sudden hearing loss who did not have complete recovery or had a partial recovery with systemic treatment enrolled in this prospective study. After the topical anesthesia, 0.4-0.5 mL of methyl prednisolone (40 mg/mL) was administered into the middle ear from the postero-inferior quadrant of the tympanic membrane. Pure tone audiometry test was performed before each injection and after the final injection. A change more than 10 dB in the pure tone average was considered as an alteration in hearing (improvement or worsening). Complete recovery was accepted when the pure tone average was 20 dB or lower. R Re es su ul lt ts s: : The mean onset of intratympanic methyl prednisolone treatment after the hearing loss was 16±6.6 days (range: 7 -30 days). The average number of injections was 3.8±1.3 (range: 2-6). The improvement in pure tone average was statistically significant [initial median of pure tone average was 85 dB (minimum 28 dB, maximum 107 dB), final median of pure tone averages was 42.5 dB (minimum 12 dB, maximum 107dB), p=0.007]. Eleven (68.75%) patients improved, but no change was observed in 5 (31.25%) patients. Two (12.5%) patients attained complete recovery. Four (25%) patients improved to 30 dB or less in pure tone average. Statistically significant improvement was also obtained at 250, 500, 1,000, 2,000, 4,000 and 6,000 Hz frequencies. C Co on nc cl lu us si io on n: : These results suggested that intratympanic methyl prednisolone treatment for sudden hearing loss in patients who did not respond to systemic therapy appears to be a good alternative for better hearing results. K Ke ey y W Wo or rd ds s: : Hearing loss, sudden; methylprednisolone; salvage therapy; steroids Ö ÖZ ZE ET T A Am ma aç ç: : Bu çalışmanın amacı, sistemik tedaviye yeterli yanıt alınamayan ani işitme kayıplı hastalarda kurtarma tedavisi olarak uygulanan intratimpanik metil prednizolon tedavisinin etkinliğini araştırmaktır. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Bu prospektif çalışmaya, sistemik tedaviye yanıt alınamayan veya kısmi yanıt alınan 16 ani işitme kayıplı hasta alındı. Topikal anestezi sonrasında 0,4-0,5 mL metil prednizolon (40 mg/mL), timpanik membran posteroinferior kadranından orta kulağa enjekte edildi. Her enjeksiyon öncesinde ve tedavi sonunda saf ses odyometri testi yapıldı. Saf ses ortalamasında 10 desibelden daha fazla değişiklik, değişim olarak kabul edildi (iyileşme veya kötüleşme). Saf ses ortalamasının 20 dB ve daha aşağıdaki değerleri tam iyileşme olarak kabul edildi. B Bu ul lg gu ul la ar r: : İşitme kaybı başlangıcı ile intratimpanik metil prednizolon uygulaması arasındaki ortalama süre 16±6,6 gündü (7-30 gün arasında). Ortalama en...

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Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy

Cited by 147 publications

References 57 publications

Sudden Sensorineural Hearing Loss

Sudden Sensorineural Hearing Loss

The Role of High Dose Intratympanic Dexamethasone as Salvage Therapy for Idiopathic Sudden Sensorineural Hearing Loss

Intratympanic Methyl Prednisolone Salvage Therapy for Sudden Hearing Loss

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