Academic Journal
Validation of the Shoebox PureTest audiometry technology for remote data collection in clinical trials.
| Τίτλος: | Validation of the Shoebox PureTest audiometry technology for remote data collection in clinical trials. |
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| Συγγραφείς: | Robertson EE; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA. erinrobertson6287@gmail.com., Acosta RJ; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Tzoneva G; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Redington ER; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Wipperman MF; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Rai P; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Majaj R; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Barge R; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Drummond MC; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Shuldiner AR; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA., Urbanek JK; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA. |
| Πηγή: | Scientific reports [Sci Rep] 2026 Jun 12; Vol. 16 (1). Date of Electronic Publication: 2026 Jun 12. |
| Τύπος έκδοσης: | Journal Article; Validation Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : Nature Publishing Group, copyright 2011- |
| Ιατρικοί όροι (MeSH): | Data Collection*/methods , Audiometry, Pure-Tone*/methods , Audiometry, Pure-Tone*/instrumentation , Audiometry*/methods , Clinical Trials as Topic*, Humans ; Female ; Male ; Adult ; Middle Aged ; Aged ; Reproducibility of Results ; Young Adult |
| Περίληψη: | At present, traditional audiologic assessments are required to be performed in clinics and present a considerable burden to patients and sites (e.g., cost, time), particularly in clinical trials that require numerous longitudinal visits. This study evaluated an iPad-based remote audiometry technology, the Shoebox PureTest, for accuracy and usability, and aimed to determine whether it is fit for use in research and clinical studies. In participants with a wide range of hearing sensitivity, the Shoebox PureTest audiometer was determined to be sufficiently accurate, reliable, and usable, and was statistically equivalent to gold-standard conventional audiometry assessments at frequencies of 500, 1000, 2000, and 4000 Hz. The user experience survey demonstrated that > 80% of users rated the application and usability as 'good', and the overall satisfaction was rated as 'excellent' by 92% of participants. Whilst there are operational considerations for future use in clinical trials, the Shoebox PureTest audiometer has been shown to be a valid alternative to conventional hearing assessments which can be used for the optimization of clinical research studies. (© 2026. The Author(s).) |
| Competing Interests: | Declarations. Competing interests: All authors are employees and shareholders of Regeneron Pharmaceuticals, Inc. |
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| Contributed Indexing: | Keywords: Auditory sciences; Clinical trials; Remote audiometry; Remote data collection; Validated tools |
| Entry Date(s): | Date Created: 20260612 Date Completed: 20260731 Latest Revision: 20260813 |
| Update Code: | 20260813 |
| PubMed Central ID: | PMC13427756 |
| DOI: | 10.1038/s41598-026-49550-8 |
| PMID: | 42286011 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2045-2322 |
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| DOI: | 10.1038/s41598-026-49550-8 |