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This biological restoration of hearing is different from cochlear implantation (CI) that produces artificial hearing via electric stimulation of the auditory nerve. In three published trials, 21 DFNB9 patients show 244 grade I\/II adverse events (AEs), 2 grade III AEs and no serious AEs. The average gene therapy effect is substantial (52.4\u2010dB improvement from baseline complete deafness), rapid (0.74\u2010month time constant), and stable over the initial six months. However, individual outcomes vary from restored normal audibility (\u226420\u00a0dB HL) to severe hearing loss (\u226580\u00a0dB HL). Here critical knowledge gaps in gene therapy are identified such as understanding the individual variability, assessing temporal processing, and comparing efficacy with cochlear implantation. It is predicted that gene therapy will include patients with less than complete hearing loss and target other monogenic forms of congenital deafness. Advanced technologies in minimally invasive drug delivery and gene editing will further increase the safety, efficacy and applicability of gene therapy for hearing loss. Cochlear implantation likely remains the standard intervention for severe\u2010to\u2010profound hearing loss, but gene therapy will emerge as a viable alternative in treating monogenic forms of deafness.<\/jats:p>","DOI":"10.1002\/advs.202509960","type":"journal-article","created":{"date-parts":[[2025,9,23]],"date-time":"2025-09-23T10:26:51Z","timestamp":1758623211000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Treating Hearing Loss: From Cochlear Implantation to Gene Therapy"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4325-2780","authenticated-orcid":false,"given":"Fan\u2010Gang","family":"Zeng","sequence":"first","affiliation":[{"name":"Center for Hearing Research Departments of Anatomy and Neurobiology Biomedical Engineering Cognitive Sciences, Otolaryngology\u2010Head and Neck Surgery University of California Irvine  Irvine CA 92697 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jieyu","family":"Qi","sequence":"additional","affiliation":[{"name":"Department of Radiology Zhuhai People's Hospital The Affiliated Hospital of Beijing Institute of Technology Advanced Technology Research Institute School of Life Science Beijing Institute of Technology  Beijing 100081 China"},{"name":"State Key Laboratory of Hearing and Balance Science Beijing Institute of Technology  Beijing 100081 China"},{"name":"Advanced Technology Research Institute Beijing Institute of Technology  Jinan 250307 China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen\u2010Chi","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2010Head and Neck Surgery National Taiwan University College of Medicine  Taipei 100233 Taiwan"},{"name":"Department of Medical Research National Taiwan University Hospital Hsin\u2010Chu Branch  Hsinchu 302041 Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yilai","family":"Shu","sequence":"additional","affiliation":[{"name":"ENT Institute and Otorhinolaryngology Department of Eye &amp; ENT Hospital Fudan University  Shanghai 200031 China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renjie","family":"Chai","sequence":"additional","affiliation":[{"name":"Department of Radiology Zhuhai People's Hospital The Affiliated Hospital of Beijing Institute of Technology Advanced Technology Research Institute School of Life Science Beijing Institute of Technology  Beijing 100081 China"},{"name":"Department of Otolaryngology Head and Neck Surgery Zhongda Hospital State Key Laboratory of Digital Medical Engineering Jiangsu Provincial Key Laboratory of Critical Care Medicine School of Life Sciences and Technology School of Medicine Advanced Institute for Life and Health Southeast University  Nanjing 210096 China"},{"name":"Co\u2010Innovation Center of Neuroregeneration Nantong University  Nantong 226001 China"},{"name":"Department of Otolaryngology Head and Neck Surgery Sichuan Provincial People's Hospital University of Electronic Science and Technology of China  Chengdu 610072 China"},{"name":"Southeast University Shenzhen Research Institute  Shenzhen 518063 China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,23]]},"reference":[{"key":"e_1_2_10_1_1","first-page":"996","volume":"397","author":"Collaborators, G. 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