Participants
idiopathic SSHL, SSHL-related hearing loss
The study was approved by the responsible Ethics Committees of the participating centers (approval number of the leading Ethics Committee of the University Medical Center Göttingen 14/7/12). It was funded and the investigational medical product (IMP) was provided by the sponsor of this clinical trial, the Nordmark Pharma GmbH. The study was performed in accordance with the Declaration of Helsinki, version 10/2008. The complete study protocol and statistical analysis plan is available in Supplemental Material 1. All participants gave written informed consent. This study was registered in the EU Clinical Trials Register, EudraCT-No. 2012-000066-37 at 2012-07-02.Inclusion criteria comprised male or female patients aged 18–70 years presenting with acute (< 7d after onset), untreated unilateral idiopathic SSHL ≥ 30 dB in at least 2 consecutive frequencies or ≥ 20 dB in 3 consecutive frequencies and not greater than 90 dB based upon evaluation of 8 frequencies, 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz, compared to the contralateral ear. Symmetric hearing according to patient’s recollection before onset was required. Amongst others, exclusion criteria were any pre-treatment of SSHL-related hearing loss within the preceding 30 days, e.g. with steroids, or current medication that interferes with coagulation, like anticoagulants or antiplatelet drugs. All in- and exclusion criteria are listed in detail in Supplemental Material 1, page 31–32.