Safety and audiological outcome in a case series of tertiary therapy of sudden hearing loss with a biodegradable drug delivery implant for controlled release of dexamethasone to the inner ear

• DOI: 10.3389/fnins.2022.892777
• Publication Date: 2022-09-20T07:09:33Z
• Authors: Stefan K. Plontke; Arne Liebau; Eric Lehner; Daniel Bethmann; Karsten Mäder; Torsten Rahne
• Keywords: Round window; Salvage therapy

Background Intratympanic injections of glucocorticoids have become increasingly common in the treatment idiopathic sudden sensorineural hearing loss (ISSHL). However, due to their fast elimination, sustained applications been suggested for local drug delivery inner ear. Materials and methods The study is based on a retrospective chart review patients treated ISSHL at single tertiary (university) referral center. We included who were with solid, biodegradable, poly(D,L-lactic-co-glycolic acid) (PLGA)-based system providing dexamethasone extracochlear into round window niche ( n = 15) or intracochlear scala tympani 2) therapy without serviceable after primary systemic secondary intratympanic glucocorticoid therapy. evaluated feasibility safety through clinical evaluation, histological examination, functional tests [pure-tone threshold (PTA), word recognition scores (WRS)]. Results With adequate surgical preparation niche, implantation was feasible all patients. Histologic examination material showed signs resorption relevant inflammation foreign body reaction implant. In where basal part assessable during later cochlear implantation, no pathological findings found. application, average preoperative PTA 84.7 dB HL (SD: 20.0) 76.7 16.7) follow-up p 0.08). maximum WRS 14.6% 17.9) 39.3% 30.7) 0.11). Six (40%), however, reached hearing. two application did not improve. Conclusion controlled release – limited observations - appears safe. Due uncontrolled design, conclusions about efficacy are limited. These observations, may encourage initiation prospective studies using biodegradable implants as systems ear diseases.