Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis.
10.3969/j.issn.1671-7104.2023.06.018
- Author:
Jing WU
1
;
Jiazhen ZHANG
1
;
Ruhan A
1
;
Bao ZHAI
1
;
Le JIN
1
;
Xinli SHI
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
acoustic characteristics;
medical device registration;
ossicular reconstruction;
ossicular replacement prosthesis
- MeSH:
Ossicular Prosthesis;
Ossicular Replacement;
Sound;
Prosthesis Design;
Treatment Outcome
- From:
Chinese Journal of Medical Instrumentation
2023;47(6):684-689
- CountryChina
- Language:Chinese
-
Abstract:
The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.
