Experimental Pharmacological Research of New Combined Medicinal Product for Treatment of Sensorineural Hearing Loss

Introduction. Sensorineural hearing loss (SHL) affects the perception of sounds from the inner ear, auditory nerve, subcortical, and cortical auditory centers. The drug treatment of SHL is usually symptomatic and includes vasodilators, steroids, nootropics, and antioxidants. Materials and methods. The research algorithm consists of establishing the method for inducing SHL and peripheral vestibulopathy (gentamicine); experimental audiometric methods (otoacoustic emissions, Preyer reflex) for monitoring SHL; preclinical testing of static and dynamic locomotor coordination in Wistar rats (open field test, horizontal walking, and forced motor activity test to maintain balance). All procedures describing experiments involving laboratory animals were conducted in accordance with Directive 2010/63/EU and national Law no. 211/2017. Results. The test product demonstrated low acute toxicity across administration routes (ATC 5). In gentamicin-induced SHL models, animals treated with the test product showed a clear otoprotective effect, evidenced by improved otoacoustic emission results (Transitory OAE, Distortion Product OAE > 0 dB SPL; signal-to-noise ratio > 3 dB Sound Pressure Level in the 1000–4000 Hz range), and Preyer reflex at 80 dB SL in contrast to the untreated ototoxicity group (p < 0.05). Preclinical research in audiology and experimental vestibulometry demonstrated the beneficial effect of the studied product in the complex treatment of SHL and peripheral vestibular disorders (using OEA, Cat Walk, Rota Rod Tests). The fixed-dose medicinal product therapy yielded the most significant benefits, with no notable side effects observed. Conclusion. This study pharmacologically characterized a novel combined drug in capsules containing nicergoline, piracetam, and hawthorn extract, for potential use in SHL therapy. The data of experimental audiological and vestibular tests in rats encourage further preclinical and clinical research. Key messages. A novel fixed-dose combination capsule containing nicergoline, piracetam, and hawthorn extract shows otoprotective effects in gentamicin-induced sensorineural hearing loss models. Preclinical audiological and vestibular tests demonstrated significant benefits of the combined medicinal product with no notable side effects. The study supports further preclinical and clinical research for this combined drug in the treatment of sensorineural hearing loss and peripheral vestibulopathy.