Clinical Trial
Comparative Study
Journal Article
Multicenter Study
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A prospective, multi-centered study of the treatment of idiopathic sudden sensorineural hearing loss with combination therapy versus high-dose prednisone alone: a 139 patient follow-up.

OBJECTIVE: To compare combination therapy (high-dose prednisone taper (HDPT) + intratympanic dexamethasone (IT-Dex)) hearing recovery results in ISSNHL patients with those treated with HDPT alone.

DESIGN: Prospective, multicentered trial.

SETTING: Tertiary referral center.

PATIENTS: Eighty ISSNHL patients with class C or D hearing.

INTERVENTION: Eighty qualifying patients were treated with IT-Dex (10 mg/ml) every week for 3 weeks concomitant with HDPT (60 mg/d for 7 d with 7-d taper) and followed prospectively.

MAIN OUTCOME MEASURE(S): Four-tone pure tone average (PTA) at 0.25, 0.5, 1, and 2 kHz and speech discrimination scores (SDS) 2 months posttreatment; Hearing results compared retrospectively with those of 59 ISSNHL treated with HDPT alone.

RESULTS: Combination therapy and HDPT alone both provided a statistically significant benefit in audiometric parameters, especially if treated within 7 days of onset. However, 49% versus 29% (p = 0.02) of class D patients receiving combination therapy versus HDPT achieved serviceable hearing. Patients receiving combination therapy versus HDPT experienced a significantly greater improvement in PTA (34.1 ± 27 dB versus 12.0 ± 21 dB; p < 0.0001) and SDS (49.9.2 ± 38% versus 19.2 ± 36%; p < 0.0001) while achieving a significantly better final PTA (50.6 ± 28 dB versus 65.5 ± 29 dB; p = 0.005) and SDS (62.4 ± 40% versus 44.7 ± 41%; p = 0.01). Approximately 56% of class D and 40% of profound patients treated within 7 days with combination therapy achieved serviceable hearing.

CONCLUSION: Combination therapy offers ISSNHL patients the highest likelihood of achieving class A and B hearing. Differential results with combination therapy and HDPT compared with previous studies suggest time- and dose-dependent responses to the treatment of ISSNHL.

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