{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:27:27Z","timestamp":1772166447747,"version":"3.50.1"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,4,12]],"date-time":"2024-04-12T00:00:00Z","timestamp":1712880000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,4,12]],"date-time":"2024-04-12T00:00:00Z","timestamp":1712880000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Teleaudiology can potentially improve access to hearing healthcare services. Remote hearing aid fittings offer a new mode of service delivery that removes barriers of geography and access to an audiologist. Real-ear measurements (REMs) are the gold standard for hearing aid output verification but require in-clinic appointments. This study will investigate whether remote hearing aid fittings can provide clinically equivalent outcomes when compared to current, in-clinic, best practice guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Research design<\/jats:title>\n                    <jats:p>A repeated measure, double-blinded crossover design will be used. Participants will be randomly allocated to one of two groups to determine order of intervention, balanced for degree of hearing loss.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study sample<\/jats:title>\n                    <jats:p>Sixty adults with mild to moderate hearing loss and at least 1\u00a0year of experience with hearing aids will be recruited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data collection and analysis<\/jats:title>\n                    <jats:p>Participants will complete two hearing aid fitting protocols, one using an in-clinic fitting process and the other using a remote (at-home) fitting process. In-clinic fittings will include REMs with adjustments to standard (NAL-NL2) prescription targets. The two fitting protocols will then be randomly assigned to participants in a crossover design, so participants and researchers will be blinded to the order of the two fitting protocols. Participants will then have a 4-week period with follow-up appointments for participant-directed gain adjustment. For each fitting protocol, participants will complete objective measurements of final hearing aid output with REMs, speech-in-noise testing, subjective measurements of hearing aid performance, and quality of life measurements. They will then begin an identical period of living with, adjusting, and objective assessment with the other fitting protocol. Data will be analysed as repeated measures with statistical control for potential confounding variables.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Data will compare the four-frequency average real-ear aided response (4FREAR) for hearing aids programmed in-clinic and hearing aids programmed remotely, after participant-directed gain adjustments. Secondary measures will assess clinically significant differences in estimated speech intelligibility, hearing-related quality of life, hearing aid benefit, sound quality and preference, and speech-in-noise ability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study will inform the development of best practice guidelines for remote hearing aid fittings. If no clinically significant differences are found between in-clinic and remote fit hearing aids, it has the potential to expand teleaudiology initiatives.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Australian New Zealand Clinical Trial Registry,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.anzctr.org.au\/ACTRN12623000028606p.aspx\">ACTRN12623000028606p<\/jats:ext-link>\n                      .\u00a0Date of registration: 12 January 2023.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-024-08068-y","type":"journal-article","created":{"date-parts":[[2024,4,12]],"date-time":"2024-04-12T00:01:44Z","timestamp":1712880104000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2541-3771","authenticated-orcid":false,"given":"Craig","family":"Lett","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Welch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosie","family":"Dobson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,4,12]]},"reference":[{"key":"8068_CR1","volume-title":"WHO world report on hearing","author":"World Health Organization","year":"2021","unstructured":"World Health Organization. WHO world report on hearing. Geneva: World Health Organization; 2021."},{"key":"8068_CR2","unstructured":"Lewitt S. Where are all the audiologists? A UK perspective on the scarcity of hearing care services. 2022. Available at: https:\/\/www.hearingtracker.com\/pro-news\/where-are-all-the-audiologists. Accessed 29 Oct 2022."},{"key":"8068_CR3","doi-asserted-by":"publisher","first-page":"e029007","DOI":"10.1136\/bmjopen-2019-029007","volume":"9","author":"R Reddy","year":"2019","unstructured":"Reddy R, Welch D, Lima I, Thorne P, Nosa V. Identifying hearing care access barriers among older Pacific Island people in New Zealand: a qualitative study. BMJ Open. 2019;9:e029007.","journal-title":"BMJ Open"},{"issue":"S1","key":"8068_CR4","first-page":"S4","volume":"60","author":"K Mu\u00f1oz","year":"2020","unstructured":"Mu\u00f1oz K, Nagaraj N, Nichols N. Applied tele-audiology research in clinical practice during the past decade: a scoping review. Int J Audiol. 2020;60(S1):S4\u201312.","journal-title":"Int J Audiol"},{"issue":"6","key":"8068_CR5","doi-asserted-by":"publisher","first-page":"798","DOI":"10.1089\/tmj.2019.0109","volume":"26","author":"E Convery","year":"2020","unstructured":"Convery E, Keidser G, McLelland M, Groth J. A smartphone app to facilitate remote patient-provider communication in hearing health care: usability and effect on hearing aid outcomes. Telemed J E Health. 2020;26(6):798\u2013804.","journal-title":"Telemed J E Health"},{"key":"8068_CR6","first-page":"666","volume-title":"Digital Healthcare Empowering Europeans Proceedings of MIE2015: Studies in health technology and informatics","author":"A Paglialonga","year":"2015","unstructured":"Paglialonga A, Tognola G, Pinciroli F. Apps for hearing healthcare. In: Andersen SK, Stoicu-Tivadar L, H\u00f6rbst A, Cornet R, Parra Calder\u00f3n CL, Hercigonja-Szekeres M, editors. Digital Healthcare Empowering Europeans Proceedings of MIE2015: Studies in health technology and informatics. Netherlands: iOS Press; 2015. p. 666\u20138."},{"issue":"2","key":"8068_CR7","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1089\/tmj.2009.0111","volume":"16","author":"D Swanepoel","year":"2010","unstructured":"Swanepoel D, Hall JW. A systematic review of telehealth applications in audiology. Telemed J E Health. 2010;16(2):181\u2013200.","journal-title":"Telemed J E Health"},{"key":"8068_CR8","volume-title":"Australian Teleaudiology Guidelines","author":"Audiology Australia","year":"2022","unstructured":"Audiology Australia. Australian Teleaudiology Guidelines. 2022."},{"key":"8068_CR9","unstructured":"American Speech-Language-Hearing Association. Telepractice (Practice Portal). n.d.; Available at: https:\/\/www.asha.org\/practice-portal\/professional-issues\/telepractice. Accessed 29 Oct 2022."},{"key":"8068_CR10","volume-title":"Professional Practice Standards Part B Clinical Practice","author":"New Zealand Audiological Society","year":"2015","unstructured":"New Zealand Audiological Society. Professional Practice Standards Part B Clinical Practice. 2015."},{"issue":"11","key":"8068_CR11","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1089\/tmj.2014.0243","volume":"21","author":"A Visagie","year":"2015","unstructured":"Visagie A, Swanepoel DW, Eikelboom RH. Accuracy of Remote Hearing Assessment in a Rural Community. Telemed J E Health. 2015;21(11):93\u2013937.","journal-title":"Telemed J E Health"},{"key":"8068_CR12","unstructured":"Winter N, McMillan K, Finch J, da Silva D, Whitehead A, Harvey D, et al. Evaluation of a teleaudiology service in regional Australia. Int J\u00a0Audiol 2022;ePub ahead of print:1\u20139."},{"issue":"4","key":"8068_CR13","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1590\/S2179-64912012000400003","volume":"24","author":"PD Campos","year":"2012","unstructured":"Campos PD, Ferrari DV. Teleaudiology: evaluation of teleconsultation efficacy for hearing aid fitting. J Soc Bras Fonoaudiol. 2012;24(4):301\u20138.","journal-title":"J Soc Bras Fonoaudiol"},{"issue":"4","key":"8068_CR14","doi-asserted-by":"publisher","first-page":"265","DOI":"10.1080\/14992027.2021.1937348","volume":"61","author":"V Manchaiah","year":"2022","unstructured":"Manchaiah V, Eikelboom RH, Bennett RJ, Swanepoel DW. International survey of audiologists during the COVID-19 pandemic: effects on the workplace. Int J Audiol. 2022;61(4):265\u201372.","journal-title":"Int J Audiol"},{"issue":"4","key":"8068_CR15","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1080\/14992027.2020.1814432","volume":"60","author":"GH Saunders","year":"2021","unstructured":"Saunders GH, Roughley A. Audiology in the time of COVID-19: practices and opinions of audiologists in the UK. Int J Audiol. 2021;60(4):255\u201362.","journal-title":"Int J Audiol"},{"issue":"3","key":"8068_CR16","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1080\/14992027.2021.1921292","volume":"61","author":"B Parmar","year":"2022","unstructured":"Parmar B, Beukes E, Rajasingam S. The impact of COVID-19 on provision of UK audiology services & on attitudes towards delivery of telehealth services. Int J Audiol. 2022;61(3):228\u201338.","journal-title":"Int J Audiol"},{"key":"8068_CR17","unstructured":"Wadhwa M. The rise of teleaudiology in the time of COVID-19: practices and opinions of audiologists in New Zealand. Master of Audiology [Thesis]. Auckland: University of Auckland; 2022. Available from https:\/\/researchspace.auckland.ac.nz\/handle\/2292\/61381."},{"issue":"S1","key":"8068_CR18","doi-asserted-by":"publisher","first-page":"S49","DOI":"10.1080\/14992027.2020.1805804","volume":"60","author":"KFM Tao","year":"2021","unstructured":"Tao KFM, Moreira TdC, Jayakody DMP, Swanepoel DW, Brennan-Jones CG, Coetzee L, et al. Teleaudiology hearing aid fitting follow-up consultations for adults: single blinded crossover randomised control trial and cohort studies. Int J Audiol. 2021;60(S1):S49\u201360.","journal-title":"Int J Audiol"},{"key":"8068_CR19","volume-title":"Adult hearing aid fitting - abbreviated best practice guidelines","author":"New Zealand Audiological Society","year":"2021","unstructured":"New Zealand Audiological Society. Adult hearing aid fitting - abbreviated best practice guidelines. 2021."},{"key":"8068_CR20","doi-asserted-by":"crossref","first-page":"233121652199956","DOI":"10.1177\/2331216521999563","volume":"25","author":"I Almufarrij","year":"2021","unstructured":"Almufarrij I, Dillon H, Munro KJ. Does probe-tube verification of real-ear hearing aid amplification characteristics improve outcomes in adults? A systematic review and meta-analysis. Trends Hear. 2021;25:2331216521999563.","journal-title":"Trends Hear"},{"key":"8068_CR21","unstructured":"Henry T. Patients, doctors like telehealth. Here\u2019s what should come next. 2021. Available at: https:\/\/www.ama-assn.org\/practice-management\/digital\/patients-doctors-telehealthhere-s-what-should-come-next. Accessed 29 Oct 2022."},{"issue":"3","key":"8068_CR22","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","volume":"158","author":"A Chan","year":"2013","unstructured":"Chan A, Tetzlafft JM, Dore CJ, Parulekar WR, Summerskill WSM, Groves T, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200\u20137.","journal-title":"Ann Intern Med"},{"issue":"5","key":"8068_CR23","doi-asserted-by":"publisher","first-page":"1063","DOI":"10.1097\/AOG.0b013e3181d9d421","volume":"115","author":"KF Schulz","year":"2010","unstructured":"Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstetrics and gynecology (New York 1953). 2010;115(5):1063.","journal-title":"Obstetrics and gynecology (New York. 1953)"},{"key":"8068_CR24","volume-title":"Adult pure tone audiometry: best practice guidelines","author":"New Zealand Audiological Society","year":"2021","unstructured":"New Zealand Audiological Society. Adult pure tone audiometry: best practice guidelines. 2021."},{"key":"8068_CR25","volume-title":"Adult immittance audiometry: clinical protocols","author":"New Zealand Audiological Society","year":"2018","unstructured":"New Zealand Audiological Society. Adult immittance audiometry: clinical protocols. 2018."},{"key":"8068_CR26","volume-title":"Speech audiometry in diagnostic hearing assessment for young persons and adults: best practice guidelines","author":"New Zealand Audiological Society","year":"2016","unstructured":"New Zealand Audiological Society. Speech audiometry in diagnostic hearing assessment for young persons and adults: best practice guidelines. 2016."},{"issue":"5","key":"8068_CR27","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1097\/00003446-199110000-00009","volume":"12","author":"C Newman","year":"1991","unstructured":"Newman C, Weinstein B, Jacobson G, Hug G. Test-retest reliability of the Hearing Handicap Inventory for Adults. Ear Hear. 1991;12(5):355\u20137.","journal-title":"Ear Hear"},{"key":"8068_CR28","volume-title":"Data Monitoring Committees in Clinical Trials A Practical Perspective. Data Monitoring Committees in Clinical Trials","author":"SS Ellenberg","year":"2002","unstructured":"Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical Trials A Practical Perspective. Data Monitoring Committees in Clinical Trials. United Kingdom: John Wiley & Sons, Incorporated; 2002."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08068-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08068-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08068-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,12]],"date-time":"2024-04-12T00:03:15Z","timestamp":1712880195000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08068-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,12]]},"references-count":28,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8068"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08068-y","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-2993418\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,12]]},"assertion":[{"value":"5 June 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 March 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 April 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval for this trial has been granted by the New Zealand Government Health and Disability Ethics Committee, 12 May 2023, 2023 EXP 14058. All participants will complete a consent form as part of the recruitment process.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0<!--Emphasis Type='Bold' removed-->{24}"}},{"value":"A consent form will be completed as part of the recruitment process. A redacted version of the consent form is included in the\n                      \n                      .","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0<!--Emphasis Type='Bold' removed-->{32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0<!--Emphasis Type='Bold' removed-->{28}"}}],"article-number":"256"}}