Sterling W Sheffield, Molly Jacobs, Charles Ellis, Amber Gerasimchik
{"title":"直接面向消费者的设备与助听器的比较：三种听力损失的放大精度。","authors":"Sterling W Sheffield, Molly Jacobs, Charles Ellis, Amber Gerasimchik","doi":"10.1044/2023_AJA-22-00170","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The U.S. Food and Drug Administration finalized regulations for over-the-counter hearing aids (OTC-HAs) on August 17, 2022. Little is known about the comparative performance of OTC-HAs and prescription HAs. This study compared amplification accuracy of prescription HAs and direct-to-consumer devices (DTCDs, including personal sound amplification products [PSAPs] and OTC-HAs).</p><p><strong>Method: </strong>Eleven devices were programmed to meet prescriptive targets in an acoustic manikin for three degrees of hearing loss. Devices consisted of high- and low-end HAs, PSAPS, and OTC-HAs. Each was tested, and deviations from target measured with an HA analyzer at every combination of 10 frequencies and low-, average-, and high-level inputs. Accuracy was compared using a multilevel Poisson model with device-specific intercepts controlling for input level, frequency, and device type.</p><p><strong>Results: </strong>For mild-moderate hearing loss, deviations from targets were not statistically different between high- and low-end HAs, but PSAPs (5.50 dB, <i>SE</i> = 0.92 dB) and OTC-HAs (8.83 dB, <i>SE</i> = 1.10 dB) had larger differentials. For flat moderate hearing loss, compared to high-end HAs, average differentials were larger for all device types at all input levels and frequencies (Low HA: 3.82 dB, <i>SE</i> = 1.10 dB; PSAP: 9.24 dB, <i>SE</i> = 1.22 dB; OTC-HA: 8.61 dB, <i>SE</i> = 1.19 dB). For mild sloping to severe hearing loss, compared to high-end HAs, OTC-HAs (9.72 dB, <i>SE</i> = 1.20 dB) and PSAPs (7.34 dB, <i>SE</i> = 1.07 dB) had larger differentials and significant variability at the highest and lowest frequencies. Half (three) of the PSAPs and OTC-HAs met most targets within ±5 dB.</p><p><strong>Conclusions: </strong>DTCDs were unable to meet prescriptive targets for severe types of hearing loss but could meet them for mild hearing loss. This study provides an examination of current hearing devices. More research is needed to determine whether meeting prescriptive targets provides any benefit in the outcomes and performance with DTCD devices.</p>","PeriodicalId":49241,"journal":{"name":"American Journal of Audiology","volume":" ","pages":"1-12"},"PeriodicalIF":1.4000,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss.\",\"authors\":\"Sterling W Sheffield, Molly Jacobs, Charles Ellis, Amber Gerasimchik\",\"doi\":\"10.1044/2023_AJA-22-00170\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The U.S. Food and Drug Administration finalized regulations for over-the-counter hearing aids (OTC-HAs) on August 17, 2022. Little is known about the comparative performance of OTC-HAs and prescription HAs. This study compared amplification accuracy of prescription HAs and direct-to-consumer devices (DTCDs, including personal sound amplification products [PSAPs] and OTC-HAs).</p><p><strong>Method: </strong>Eleven devices were programmed to meet prescriptive targets in an acoustic manikin for three degrees of hearing loss. Devices consisted of high- and low-end HAs, PSAPS, and OTC-HAs. Each was tested, and deviations from target measured with an HA analyzer at every combination of 10 frequencies and low-, average-, and high-level inputs. Accuracy was compared using a multilevel Poisson model with device-specific intercepts controlling for input level, frequency, and device type.</p><p><strong>Results: </strong>For mild-moderate hearing loss, deviations from targets were not statistically different between high- and low-end HAs, but PSAPs (5.50 dB, <i>SE</i> = 0.92 dB) and OTC-HAs (8.83 dB, <i>SE</i> = 1.10 dB) had larger differentials. For flat moderate hearing loss, compared to high-end HAs, average differentials were larger for all device types at all input levels and frequencies (Low HA: 3.82 dB, <i>SE</i> = 1.10 dB; PSAP: 9.24 dB, <i>SE</i> = 1.22 dB; OTC-HA: 8.61 dB, <i>SE</i> = 1.19 dB). For mild sloping to severe hearing loss, compared to high-end HAs, OTC-HAs (9.72 dB, <i>SE</i> = 1.20 dB) and PSAPs (7.34 dB, <i>SE</i> = 1.07 dB) had larger differentials and significant variability at the highest and lowest frequencies. Half (three) of the PSAPs and OTC-HAs met most targets within ±5 dB.</p><p><strong>Conclusions: </strong>DTCDs were unable to meet prescriptive targets for severe types of hearing loss but could meet them for mild hearing loss. This study provides an examination of current hearing devices. More research is needed to determine whether meeting prescriptive targets provides any benefit in the outcomes and performance with DTCD devices.</p>\",\"PeriodicalId\":49241,\"journal\":{\"name\":\"American Journal of Audiology\",\"volume\":\" \",\"pages\":\"1-12\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2023-12-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Audiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1044/2023_AJA-22-00170\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Audiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1044/2023_AJA-22-00170","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY","Score":null,"Total":0}
Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss.
Purpose: The U.S. Food and Drug Administration finalized regulations for over-the-counter hearing aids (OTC-HAs) on August 17, 2022. Little is known about the comparative performance of OTC-HAs and prescription HAs. This study compared amplification accuracy of prescription HAs and direct-to-consumer devices (DTCDs, including personal sound amplification products [PSAPs] and OTC-HAs).
Method: Eleven devices were programmed to meet prescriptive targets in an acoustic manikin for three degrees of hearing loss. Devices consisted of high- and low-end HAs, PSAPS, and OTC-HAs. Each was tested, and deviations from target measured with an HA analyzer at every combination of 10 frequencies and low-, average-, and high-level inputs. Accuracy was compared using a multilevel Poisson model with device-specific intercepts controlling for input level, frequency, and device type.
Results: For mild-moderate hearing loss, deviations from targets were not statistically different between high- and low-end HAs, but PSAPs (5.50 dB, SE = 0.92 dB) and OTC-HAs (8.83 dB, SE = 1.10 dB) had larger differentials. For flat moderate hearing loss, compared to high-end HAs, average differentials were larger for all device types at all input levels and frequencies (Low HA: 3.82 dB, SE = 1.10 dB; PSAP: 9.24 dB, SE = 1.22 dB; OTC-HA: 8.61 dB, SE = 1.19 dB). For mild sloping to severe hearing loss, compared to high-end HAs, OTC-HAs (9.72 dB, SE = 1.20 dB) and PSAPs (7.34 dB, SE = 1.07 dB) had larger differentials and significant variability at the highest and lowest frequencies. Half (three) of the PSAPs and OTC-HAs met most targets within ±5 dB.
Conclusions: DTCDs were unable to meet prescriptive targets for severe types of hearing loss but could meet them for mild hearing loss. This study provides an examination of current hearing devices. More research is needed to determine whether meeting prescriptive targets provides any benefit in the outcomes and performance with DTCD devices.
期刊介绍：
Mission: AJA publishes peer-reviewed research and other scholarly articles pertaining to clinical audiology methods and issues, and serves as an outlet for discussion of related professional and educational issues and ideas. The journal is an international outlet for research on clinical research pertaining to screening, diagnosis, management and outcomes of hearing and balance disorders as well as the etiologies and characteristics of these disorders. The clinical orientation of the journal allows for the publication of reports on audiology as implemented nationally and internationally, including novel clinical procedures, approaches, and cases. AJA seeks to advance evidence-based practice by disseminating the results of new studies as well as providing a forum for critical reviews and meta-analyses of previously published work.
Scope: The broad field of clinical audiology, including audiologic/aural rehabilitation; balance and balance disorders; cultural and linguistic diversity; detection, diagnosis, prevention, habilitation, rehabilitation, and monitoring of hearing loss; hearing aids, cochlear implants, and hearing-assistive technology; hearing disorders; lifespan perspectives on auditory function; speech perception; and tinnitus.
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