助听器与辅听设备基本性能及使用建议的专家共识
王硕;陈赤榕;金会听力健康医疗服务专家委员会 ;张丽萍;杨欣怡;董瑞娟;曹永茂;黄治物
1:中国电子音响行业协会助听行业分会
2:上海市医学会听觉与前庭医学专科分会
3:中国医疗国际保健交流促进会听力学分会
4:中国听力医学发展基金会
摘要关键词基金项目(Foundation):作者参考文献1 宫蕊，卜行宽.全国部分省听力障碍流行现状和康复需求及服务利用况.见：龙墨，郑晓瑛，卜行宽，等，主编.中国听力健康报告(2021)[M].北京：社会科学文献出版社，2021,72-83.
2 He P,Wen X,Hu X,et al.Hearing aid acquisition in Chinese older adults with hearing loss[J].American Journal of Public Health,2018,108(2):241-247.
3 European Hearing Instrument Manufacturers Association.ChinaTrak[EB/OL].[2024-09-11].https://www.ehima.com/wp-content/uploads/2021/06/ChinaTrak_2020.pdf.
4 Food and Drug Administration.OTC Hearing Aids:What You Should Know[EB/OL].[2024-09-11].https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know.
5 Food and Drug Administration.Hearing Aids and Personal Sound Amplification Products:What to Know[EB/OL].https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know.
6 Food and Drug Administration.Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products[EB/OL].https://www.fda.gov/media/87330/download.
7 Food and Drug Administration.Code of Federal Regulations Title 21:21 CFR 801.420,21 CFR 800.30,21 CFR 801.422,https://www.accessdata.fda.gov/
8 蒋涛.OTC助听器与PSAP个人放大器的区别[J].中国听力语言康复科学杂志，2017,15(6):471-474.
9 郗昕，公泽忠，曾凡钢.非处方助听器：机遇与挑战并存[J].听力学及言语疾病杂志，2023,31(4):293-299.
10 United States:National Archives and Records Administration:Office of the Federal Register,United States:Department of Health and Human Services,United States:Food and Drug Administration.Medical Devices;Ear,Nose,and Throat Devices;Establishing Over-the-Counter Hearing Aids.Part II:Rules and Regulations[EB/OL].Office of the Federal Register,National Archives and Records Administration,2022[2024-09-11].https://www.govinfo.gov/app/details/FR-2022-08-17/2022-17230.
11 银力，屠文河，高姗仙，等.耳聋与助听设备的选择[J].中国医疗器械信息，2016,22 (5):23-29,63.
12 (澳)哈维·迪龙，著.胡向阳，主译.助听器[M].北京：华夏出版社，2019.9-11,415.
13 Macworld.Best wireless earbuds for iPhone[EB/OL].https://www.macworld.com/article/668628/best-wireless-headphones.html.
14 郗昕，赵辉，庞安然，等.牙骨传导听力系统对成人单侧感音神经性患者干预早期的听力学成效分析[J].中华耳鼻咽喉头颈外科杂志.2021,56(5):478-486.
15 张天宇，李辰龙，傅窈窈，等.骨传导助听器在先天性外中耳畸形中的应用进展[J].中国眼耳鼻喉科杂志，2024,24(4):284-287.
16 Ellsperman SE,Nairn EM,Stucken EZ.Review of bone conduction hearing devices[J].Audiol Res,2021,11(2):207-219.
17 张天宇，任柳杰，李辰龙，等.中耳力学：骨传导与骨传导助听器[J].听力学及言语疾病杂志，2024,32(5):482-484.
18 Food and Drug Administration.Other Hearing Devices and Products[EB/OL].https://www.fda.gov/medical-devices/hearing-aids/other-hearing-devices-and-products#1.
19 American Academy of Audiology.Assistive listening and alerting devices.https://www.audiology.org/consumers-and-patients/managing-hearing-loss/assistive-listening-and-alerting-devices/#:～:text=Assistive%20listening%20devices%20(ALDs)%20are,varying%20degrees%20of%20hearing%20impairment.
20 American Academy of Audiology.The audiologist's guide to hearing aids,personal sound amplification products,hearables,and Over-The-Counter devices[EB/OL].https://www.audiology.org/wp-content/uploads/2022/03/Audiologists-Guide-to-OTCs_Updated-March-2022.pdf.
21 Seol HY,Moon IJ.Hearables as a gateway to hearing health care[J].Clinical and Experimental Otorhinolaryngology,2022,15(2):127-134.
22 Food and Drug Administration.Hearing Aids[EB/OL].https://www.fda.gov/medical-devices/consumer-products/hearing-aids.
23 World Health Organizaiton,Telecommunication Standardization Sector.Guidelines for safe listening devices/systems[EB/OL].https://www.itu.int/ITU-T/recommendations/rec.aspx?rec=14953&lang=zh.