Treatment of sudden sensorineural hearing loss with transtympanic injection of steroids as single therapy: a randomized clinical study

Abstract

The aim of this study was to verify the efficacy and the safety of transtympanic dexamethasone to treat sudden sensorineural hearing loss as first and single drug method. Considering ethical implication of performing a mininvasive procedure on middle ear, we matched such proposed treatment with systemic prednisone administration that represents the widest adopted protocol. Randomized prospective study was conducted. The inclusion criterion was a sudden sensorineural hearing loss of at least 30 dB across three contiguous frequencies over a period of 24 h. Group A received transtympanic steroid injections; Group B received oral administration of steroids. 25 patients were treated with transtympanic therapy whereas 21 underwent systemic treatment. The mean of initial PTA was 59 dB for the whole series: 65 dB for group A and 51 dB for group B. The recovery better than 10 dB was obtained in 80% of patients of group A and in 17 81% of patients of group B, with a total of 80.5%. The mean relative gain in PTA was 41.16% in the group A and 44.7% in the group B. In the frequencies tested (0.5, 1, 2, and 4 kHz) PTA improvements after transtympanic treatment were higher than after systemic treatment, but these differences were not statistically significant (P = 0.61). Both transtympanic and systemic treatment had similar clinical recovery times. This prospective randomized clinical study showed good result in terms of hearing recovery, better than the expected results of the simple observation without treatment. We can consider transtympanic administration as a first line treatment, because of the statistical analysis confirmed similar results with systemic therapy, reducing possible side effects of systemic drug administration. The delay of treatment does not influence the outcome, allowing treating patients within 10 days of onset.

Intratympanic steroids as primary initial treatment of idiopathic sudden sensorineural hearing loss

“…As others have wisely pointed out, given that systemic steroid therapy is the most commonly adopted treatment, and that ITS have been successfully used for salvage treatment after systemic steroids have failed [12,[22][23][24], moving onto ITS as first-line treatment is a logical step when seeking out the best treatment outcome with the least adverse effects [25]. Moreover, several trials have proven that primary treatment with ITS is at least as effective as treatment with systemic steroids [14,16,[25][26][27].…”

“…An improvement of more than 10 dB in PTA was reported in 80 % of the 25 patients treated by Dispenza et al [25] using intratympanic dexamethasone on a once a week regimen for a period of 4 weeks. In the study by Kara et al [15] intratympanic dexamethasone achieved a gain of 10 dB or more in 86 % of the 29 patients treated with daily ITS for 5 consecutive days.…”

“…Tsai et al [17] obtained a statistically significant difference in hearing recovery if treatment began before 7 days (76 %) or after 7 days (50 %). On the other hand, Dispenza et al [25] showed no relationship between treatment delay and outcome in their randomized prospective study, although they recommend a time window of 10 days for the initiation of treatment.…”

Sudden Sensorineural Hearing Loss: Results of intratympanic steroids as salvage treatment

“…As shown in our previous report [2], the outcome is not strictly related to the time of treatment start after the hearing loss. This was also noted by Parnes et al who treated 37 patients affected by several inner ear disorders [10] and by Ho et al in 39 cases [24].…”

“…The estimated incidence of such disease is 5 to 20 cases per 100,000 annually [1]. However the exact incidence is underestimated, because many patients who recover early (within first few days) are unlikely to seek medical care [2]. The rate of spontaneous recovery is approximately between 32% and 70% which encourage some otologists not to treat SSHL patients [3].…”