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However, research over the past two decades has contributed to a growing understanding of the pathological mechanisms in the cochlea that result in hearing difficulties. The concept that a loss of the synapses connecting inner hair cells with the auditory nerve (cochlear synaptopathy) contributes to hearing loss has gained considerable attention. Both animal and human post-mortem studies support the idea that these synapses (ribbon synapses) are highly vulnerable to noise, ototoxicity, and the aging process. Their degeneration has been suggested as an important factor in the speech-in-noise difficulties commonly experienced by those suffering with hearing loss. Neurotrophins such as brain derived neurotrophic factor (BDNF) have the potential to restore these synapses and provide improved hearing function. OTO-413 is a sustained exposure formulation of BDNF suitable for intratympanic administration that in preclinical models has shown the ability to restore ribbon synapses and provide functional hearing benefit. A phase 1\/2 clinical trial with OTO-413 has provided initial proof-of-concept for improved speech-in-noise hearing performance in subjects with hearing loss. Key considerations for the design of this clinical study, including aspects of the speech-in-noise assessments, are discussed.<\/jats:p>","DOI":"10.1121\/10.0011510","type":"journal-article","created":{"date-parts":[[2022,6,13]],"date-time":"2022-06-13T08:44:19Z","timestamp":1655109859000},"page":"3937-3946","update-policy":"https:\/\/doi.org\/10.1063\/aip-crossmark-policy-page","source":"Crossref","is-referenced-by-count":22,"title":["A neurotrophic approach to treating hearing loss: Translation from animal models to clinical proof-of-concept"],"prefix":"10.1121","volume":"151","author":[{"given":"Alan C.","family":"Foster","sequence":"first","affiliation":[{"name":"Research and Preclinical Development, Otonomy Inc. 1 , 4796 Executive Drive, San Diego, California 92121, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Szobota","sequence":"additional","affiliation":[{"name":"Research and Preclinical Development, Otonomy Inc. 1 , 4796 Executive Drive, San Diego, California 92121, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrice","family":"Piu","sequence":"additional","affiliation":[{"name":"Research and Preclinical Development, Otonomy Inc. 1 , 4796 Executive Drive, San Diego, California 92121, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie E.","family":"Jacques","sequence":"additional","affiliation":[{"name":"Research and Preclinical Development, Otonomy Inc. 1 , 4796 Executive Drive, San Diego, California 92121, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Moore","sequence":"additional","affiliation":[{"name":"Communication Sciences Research Center, Cincinnati Children's Hospital 2 , 3333 Burnet Avenue, Cincinnati, Ohio 45229-3026, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria A.","family":"Sanchez","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology \u2013 Head & Neck Surgery, University of South Florida 3 , 12901 Bruce B. Downs Blvd., MDC 73, Tampa, Florida 33620, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffery J.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Clinical Sciences, Otonomy Inc. 4 , 4796 Executive Drive, San Diego, California 92121, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"231","published-online":{"date-parts":[[2022,6,13]]},"reference":[{"key":"2023081003200028400_c1","article-title":"A first-in-human study of OTO-413, an intratympanic sustained-exposure formulation of BDNF, for the treatment of speech-in-noise hearing impairment","year":"2021"},{"key":"2023081003200028400_c2","doi-asserted-by":"publisher","first-page":"eaal1670","DOI":"10.1126\/scisignal.aal1670","article-title":"Multiplex quantitative assays indicate a need for reevaluating reported small-molecule TrkB agonists","volume":"10","year":"2017","journal-title":"Sci. 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