{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T18:19:54Z","timestamp":1792693194152,"version":"4.5.0"},"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>\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Fewer than 20% of US adults with hearing loss use hearing aids due to barriers like high cost. Over-the-counter (OTC) hearing aids offer a potential solution, incorporating self-fitting strategies via smartphone apps. Self-fitting strategies have been validated for Food and Drug Administration (FDA)\u2013approved OTC hearing aids compared with prescription-based approaches. However, no direct comparative analysis exists between in situ audiometry and self-adjustment strategies using self-fitting OTC (OTC-SF) hearing aids.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To compare self-adjustment and in situ audiometry self-fitting strategies in OTC-SF hearing aids for adults with mild to moderate hearing difficulties.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design Settings and Participants<\/jats:title>\n                    <jats:p>A crossover, within-participant pseudorandomized clinical trial was conducted between July and November 2023. Twenty-eight participants were pseudo-randomly assigned to 1 of the 2 self-fitting strategies, and they experienced both interventions for 4 consecutive weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>The self-adjustment group manually adjusted settings, including overall gain and spectral tilt, using Lexie B2 hearing aids, while the in situ audiometry group used Lexie B2 Plus hearing aids (Lexie Hearing by hearX Group), with an automated fitting based on in situ tests conducted through the app.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>The primary outcome was Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary outcomes were International Outcome Inventory for Hearing Aids (IOI-HA), speech-in-noise tests (DIN and QuickSIN), and real-ear measurements (REMs). Measures were completed at baseline and after the 4-week field trial using each strategy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Twenty-eight participants (mean [SD] age, 60.2 [12.0] years) were included; 14 men and 14 women. Self-adjustment and in situ audiometry strategies produced no clinically meaningful differences across various outcome measures, including overall APHAB benefit (Cohen\n                      <jats:italic>d<\/jats:italic>\n                      \u2009=\u20090.2; 95% CI, \u22120.2 to 0.6) and overall IOI-HA satisfaction (Rosenthal\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u20090.0; 95% CI, \u22120.3 to 0.2). Self-adjustment users reported higher satisfaction (Rosenthal\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u2009\u22120.4; 95% CI, \u22120.6 to \u22120.1) and longer daily use (Rosenthal\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u2009\u22120.3; 95% CI, \u20130.5 to 0.0) compared with those using in situ audiometry. No clinically meaningful differences were observed in speech-in-noise benefit and real-ear measurements.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance<\/jats:title>\n                    <jats:p>In this clinical trial of OTC-SF hearing aids, self-adjustment and in situ audiometry strategies resulted in similar outcomes. However, self-adjustment may produce higher satisfaction and longer daily use, highlighting the potential advantages of active user involvement in the fitting process. Further investigation is needed for long-term outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05782153?tab=history&amp;amp;amp;a=3\">NCT05782153<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamaoto.2024.2007","type":"journal-article","created":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T11:44:19Z","timestamp":1721907859000},"page":"784","source":"Crossref","is-referenced-by-count":19,"title":["Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids"],"prefix":"10.1001","volume":"150","author":[{"given":"Megan","family":"Knoetze","sequence":"first","affiliation":[{"name":"Department of Speech-language Pathology and Audiology, University of Pretoria, Pretoria, South Africa"},{"name":"Virtual Hearing Lab, a Collaborative initiative between the University of Colorado School of Medicine, Aurora, Colorado, and the University of Pretoria, Pretoria, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinaya","family":"Manchaiah","sequence":"additional","affiliation":[{"name":"Department of Speech-language Pathology and Audiology, University of Pretoria, Pretoria, South Africa"},{"name":"Virtual Hearing Lab, a Collaborative initiative between the University of Colorado School of Medicine, Aurora, Colorado, and the University of Pretoria, Pretoria, South Africa"},{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, University of Colorado School of Medicine, Aurora, Colorado"},{"name":"UCHealth Hearing and Balance, University of Colorado Hospital, Aurora"},{"name":"Department of Speech and Hearing, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karina","family":"De Sousa","sequence":"additional","affiliation":[{"name":"Department of Speech-language Pathology and Audiology, University of Pretoria, Pretoria, South Africa"},{"name":"Virtual Hearing Lab, a Collaborative initiative between the University of Colorado School of Medicine, Aurora, Colorado, and the University of Pretoria, Pretoria, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Moore","sequence":"additional","affiliation":[{"name":"Communication Sciences Research Center, Patient Services Research, 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":"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, a Collaborative initiative between the University of Colorado School of Medicine, Aurora, Colorado, and the University of Pretoria, Pretoria, South Africa"},{"name":"Department of Otolaryngology\u2013Head and Neck Surgery, University of Colorado School of Medicine, Aurora, Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"key":"ooi240044r2","doi-asserted-by":"publisher","DOI":"10.1177\/23312165231160978","article-title":"U.S. population data on hearing loss, trouble hearing, and hearing-device use in adults: National Health and Nutrition Examination Survey, 2011-12, 2015-16, and 2017-20.","volume":"27","author":"Humes","year":"2023","journal-title":"Trends Hear"},{"issue":"3","key":"ooi240044r3","doi-asserted-by":"publisher","first-page":"246","DOI":"10.1080\/17483107.2020.1822449","article-title":"Hearing aid affordability in the United States.","volume":"18","author":"Jilla","year":"2023","journal-title":"Disabil Rehabil Assist Technol"},{"key":"ooi240044r5","doi-asserted-by":"publisher","DOI":"10.1177\/2331216519900589","article-title":"Validation of a self-fitting method for over-the-counter hearing aids.","volume":"24","author":"Sabin","year":"2020","journal-title":"Trends Hear"},{"issue":"1","key":"ooi240044r6","doi-asserted-by":"publisher","first-page":"5","DOI":"10.3766\/jaaa.26.1.2","article-title":"Factors affecting reliability and validity of self-directed automatic in situ audiometry: implications for self-fitting hearing AIDS.","volume":"26","author":"Convery","year":"2015","journal-title":"J Am Acad Audiol"},{"issue":"4","key":"ooi240044r7","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1177\/1084713811427707","article-title":"A self-fitting hearing aid: need and concept.","volume":"15","author":"Convery","year":"2011","journal-title":"Trends Amplif"},{"issue":"3S","key":"ooi240044r8","doi-asserted-by":"publisher","first-page":"430","DOI":"10.1044\/2017_AJA-16-0125","article-title":"A \u201cGoldilocks\u201d approach to hearing-aid self-fitting: user interactions.","volume":"26","author":"Boothroyd","year":"2017","journal-title":"Am J Audiol"},{"issue":"1","key":"ooi240044r9","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1097\/AUD.0000000000000617","article-title":"A \u201cGoldilocks\u201d approach to hearing aid self-fitting: ear-canal output and speech intelligibility index.","volume":"40","author":"Mackersie","year":"2019","journal-title":"Ear Hear"},{"issue":"12","key":"ooi240044r10","doi-asserted-by":"publisher","first-page":"868","DOI":"10.3109\/14992027.2010.503664","article-title":"Validity and reliability of in-situ air conduction thresholds measured through hearing aids coupled to closed and open instant-fit tips.","volume":"49","author":"O\u2019Brien","year":"2010","journal-title":"Int J Audiol"},{"issue":"1","key":"ooi240044r11","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1159\/000457829","article-title":"In situ hearing tests for the purpose of a self-fit hearing aid.","volume":"22","author":"Boymans","year":"2017","journal-title":"Audiol Neurootol"},{"issue":"4","key":"ooi240044r12","doi-asserted-by":"publisher","first-page":"794","DOI":"10.1097\/AUD.0000000000000663","article-title":"Factors associated with successful setup of a self-fitting hearing aid and the need for personalized support.","volume":"40","author":"Convery","year":"2019","journal-title":"Ear Hear"},{"issue":"2","key":"ooi240044r13","doi-asserted-by":"publisher","first-page":"314","DOI":"10.1044\/2022_AJA-22-00130","article-title":"Comparing hearing aid outcomes in adults using over-the-counter and hearing care professional service delivery models.","volume":"32","author":"Swanepoel","year":"2023","journal-title":"Am J Audiol"},{"issue":"6","key":"ooi240044r14","doi-asserted-by":"publisher","first-page":"522","DOI":"10.1001\/jamaoto.2023.0376","article-title":"Effectiveness of an over-the-counter self-fitting hearing aid compared with an audiologist-fitted hearing aid: a randomized clinical trial.","volume":"149","author":"De Sousa","year":"2023","journal-title":"JAMA Otolaryngol Head Neck Surg"},{"key":"ooi240044r15","doi-asserted-by":"publisher","DOI":"10.3389\/fragi.2023.1105879","article-title":"Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss.","volume":"4","author":"Manchaiah","year":"2023","journal-title":"Front Aging"},{"key":"ooi240044r17","doi-asserted-by":"publisher","first-page":"27","DOI":"10.11621\/pir.2015.0303","article-title":"Effect size, confidence intervals and statistical power in psychological research.","volume":"8","author":"Tellez","year":"2015","journal-title":"Psychol Russ"},{"issue":"4","key":"ooi240044r18","doi-asserted-by":"publisher","first-page":"211","DOI":"10.1177\/1084713812468511","article-title":"NAL-NL2 empirical adjustments.","volume":"16","author":"Keidser","year":"2012","journal-title":"Trends Amplif"},{"issue":"4","key":"ooi240044r19","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1177\/1084713811424886","article-title":"Perception of a self-fitting hearing aid among urban-dwelling hearing-impaired adults in a developed country.","volume":"15","author":"Convery","year":"2011","journal-title":"Trends Amplif"},{"key":"ooi240044r4","volume-title":"Medical Devices; Ear, Nose, and Throat Devices","author":"Food and Drug Administration","year":"2022"},{"key":"ooi240044r1","unstructured":"World Health Organization. World Report on Hearing. 2021. Accessed January 22, 2024. https:\/\/www.who.int\/publications\/i\/item\/world-report-on-hearing"},{"key":"ooi240044r16","unstructured":"EF SET. English test with free certification. 2024. Accessed January 22, 2024. https:\/\/www.efset.org"}],"container-title":["JAMA Otolaryngology\u2013Head &amp; Neck Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamaotolaryngology\/articlepdf\/2821570\/jamaotolaryngology_knoetze_2024_oi_240044_1724860405.44973.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,12]],"date-time":"2024-09-12T11:27:22Z","timestamp":1726140442000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamaotolaryngology\/fullarticle\/2821570"}},"subtitle":["A Crossover Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2024,9,1]]},"references-count":19,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,9,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamaoto.2024.2007","relation":{},"ISSN":["2168-6181"],"issn-type":[{"value":"2168-6181","type":"print"}],"subject":[],"published":{"date-parts":[[2024,9,1]]}}}