Controlled release dexamethasone implants in the round window niche for salvage treatment of idiopathic sudden sensorineural hearing loss.
OBJECTIVE
To evaluate the feasibility and hearing outcome of a biocompatible degradable dexamethasone releasing implant for continuous drug delivery to the round window membrane in patients with idiopathic sudden sensorineural hearing loss (ISSHL) and insufficient recovery after systemic high dose glucocorticoid therapy.


METHODS
Five patients with profound or moderate-to-severe hearing loss after systemic high-dose prednisolone for ISSHL received local salvage therapy with a controlled release dexamethasone implant in the middle ear.


METHODS
Pieces of a sterile rod shaped poly(D,L-lactide-co-glycolide) PLGA polymer matrix containing a total of 0.7 mg dexamethasone, which is approved for intravitreal use were implanted into the round window niche.


METHODS
Intraoperative handling and feasibility and hearing recovery as measured by change in pure tone threshold, final word recognition score, and categories of improvement were evaluated.


RESULTS
The implants were surgically placed without major difficulties. The mean hearing threshold significantly improved at follow up by 31 ± 31 dB HL (from 94 ± 27 to 63 ± 36 dB HL; p < 0.05). Two of five patients recovered completely. One patient showed partial hearing recovery with serviceable hearing.


CONCLUSIONS
Although no drugs are currently approved for local therapy of inner ear disorders, there is increasing evidence that intratympanic glucocorticoids are effective as salvage therapy in ISSHL. The present study has shown encouraging results with a biodegradable polymer delivery system, demonstrating the translation of preclinical studies with controlled drug delivery into clinical practice.
*Department of Otorhinolaryngology-Head and Neck Surgery, University of Halle-Wittenberg, Halle (Saale); †Institute of Pharmacy, Pharmaceutics and Biopharmaceutics, Pharmaceutical Technology Group, University of Halle-Wittenberg, Halle (Saale), Germany; and ‡Department of Otolaryngology, Washington University School of Medicine, St. Louis, Missouri, U.S.A.
Stefan K
SK
Plontke
Alexander
A
Glien
Torsten
T
Rahne
Karsten
K
Mäder
Alec N
AN
Salt
D000368:Aged; D001301:Audiometry, Pure-Tone; D003692:Delayed-Action Preparations / Q000008:administration & dosage* / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D016503:Drug Delivery Systems; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006319:Hearing Loss, Sensorineural / Q000188:drug therapy*; D003639:Hearing Loss, Sudden / Q000188:drug therapy*; D006320:Hearing Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D012405:Round Window, Ear / Q000187:drug effects*; D016896:Treatment Outcome; D014432:Tympanic Membrane / Q000187:drug effects*
D003692:Delayed-Action Preparations; D005938:Glucocorticoids; D003907:Dexamethasone