{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T03:31:24Z","timestamp":1790047884653,"version":"4.0.1"},"reference-count":19,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Otolaryngol Head Neck Surg"],"published-print":{"date-parts":[[2024,9,1]]},"abstract":"<jats:sec id=\"ab-ooi240042-4\">\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>With rising interest in over-the-counter (OTC) hearing aids as an alternative to traditional audiologist-fit devices, understanding their long-term efficacy is crucial. However, given the novelty of the US Food and Drug Administration category of OTC hearing aids, minimal evidence currently supports their long-term efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ooi240042-5\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To compare the long-term self-reported outcomes at 8 months of self-fit OTC hearing aids to the same hearing aids fit by audiologists.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ooi240042-6\">\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>Building on a previous randomized clinical trial, this follow-up comparative effectiveness research study reassessed a number of the original participants that were not lost to follow-up. Participants were initially divided into those with self-fit OTC hearing aids and those with audiologist-fit devices. Approximately 8 months after fitting, participants completed self-reported questionnaires. Missing data were addressed through multiple imputation. The original noninferiority trial was conducted at the University of Pretoria in South Africa from April 2022 to August 2022. The current analysis took place between July 7, 2023, to November 20, 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ooi240042-7\">\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>In the original trial, participants in the self-fit device group received a pair of OTC hearing aids and independently fit them with remote support as needed. The audiologist-fit device group received the same hearing aids fit by a certified audiologist using best practices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ooi240042-8\">\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>The main outcomes were self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ooi240042-9\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 64 participants in the trial, 44 participants were included in the extension study (21 [47.7%] in the audiologist-fit group; 23 [52.3%] in the self-fit group). The mean (SD) age of these participants was 63.0 (13.2) years, and 21 (47.7%) were male. At the long-term follow-up, self-fit and audiologist-fit groups showed no significant differences in the APHAB global score (mean difference, 0.02 [95% CI, \u22127.1 to 7.1]; Cohen\n                      <jats:italic>d<\/jats:italic>\n                      , 0.01 [95% CI, \u22120.5 to 0.5]) or the IOI-HA total score (mean difference, 1.5 [95% CI, \u22121.4 to 4.4]; Cohen\n                      <jats:italic>d<\/jats:italic>\n                      , 0.3 [95% CI, \u22120.2 to 0.8]). From 6 weeks to 8 months, no clinically meaningful group-time interaction was found between groups for the APHAB global score (Cohen\n                      <jats:italic>d<\/jats:italic>\n                      , 0.1 [95% CI, \u22120.2 to 0.3]), but a significant interaction for the IOI-HA total score was found (Cohen\n                      <jats:italic>d<\/jats:italic>\n                      , \u22120.6 [95% CI, \u22120.8 to \u22120.3]), with the self-fit group generally performing better.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"ab-ooi240042-10\">\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This comparative effectiveness research study demonstrated that self-fit OTC hearing aids can offer comparable long-term benefits to audiologist-fit hearing aids for individuals with mild to moderate hearing loss.<\/jats:p>\n                  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University of Colorado and the University of Pretoria, Aurora, Colorado"},{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, University of Colorado School of Medicine, Aurora"},{"name":"UCHealth Hearing and Balance, University of Colorado Hospital, Aurora"},{"name":"Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Moore","sequence":"additional","affiliation":[{"name":"Communication Sciences Research Center, Cincinnati Children\u2019s Hospital Medical Center and University of Cincinnati, Cincinnati, Ohio"},{"name":"Manchester Centre for Audiology and Deafness, University of Manchester, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marien A.","family":"Graham","sequence":"additional","affiliation":[{"name":"Department of Science, Mathematics and Technology Education, University of Pretoria, Pretoria, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"De Wet","family":"Swanepoel","sequence":"additional","affiliation":[{"name":"Department of Speech-Language Pathology and Audiology, University of Pretoria, Pretoria, South Africa"},{"name":"Virtual Hearing Lab, Collaborative Initiative Between the University of Colorado and the University of Pretoria, Aurora, Colorado"},{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, University of Colorado School of Medicine, Aurora"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"3","key":"ooi240042r1","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1001\/archinternmed.2011.1408","article-title":"Prevalence of hearing aid use among older adults in the United States.","volume":"172","author":"Chien","year":"2012","journal-title":"Arch Intern 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