Discussion on key points for technical evaluation of bone guided hearing aids
10.3760/cma.j.cn121382-20240129-00315
- VernacularTitle:骨导式助听器产品技术审评要点探讨
- Author:
Jiajun HE
1
;
Qingjie YU
;
Deshuang GOU
Author Information
1. 天津市医疗器械审评查验中心，天津 300000
- Keywords:
Medical devices;
Hearing aids;
Bone conduction;
Technical review
- From:
International Journal of Biomedical Engineering
2024;47(3):300-304
- CountryChina
- Language:Chinese
-
Abstract:
Bone-guided hearing aids are an important means of compensating for hearing loss. In recent years, with the advancement and iteration of new technologies and functions, the development of bone-guided hearing aids has been progressing rapidly, resulting in the constant emergence of various new products. However, the current lack of corresponding evaluation standards for this product has led to difficulties in registration, marketing, quality control, and evaluation standards. This study focuses on the technical evaluation perspective and elaborates on the main points of focus in technical evaluation work, such as product structure composition, main risks, performance requirements, and clinical evaluation. The aim is to provide a basis for the design and development, production, registration, use, and post-market supervision of the product.
