场外助听器:它们安全有效吗?
Rema Shah1, Sarah G Wilkins1, Neelima Panth1,2
1Yale University School of Medicine, New Haven, Connecticut, USA.
概括
非处方 (OTC) 助听器在安全性方面与处方设备相似,但有效性略低. 需要进行进一步的研究,以优化OTC助听器对各种听力损失类型的性能.
科学领域:
- 听力学 听力学是指听力学.
- 监管科学 监管科学
- 生物医学工程 生物医学工程
背景情况:
- 美国FDA在2022年为非处方 (OTC) 助听器建立了一个新类别.
- 这些设备适用于轻度至中度听力损失的个人.
研究的目的:
- 为了比较OTC助听器与处方助听器的安全性和有效性.
- 为了评估不同听力损失配置的设备性能.
主要方法:
- 采用了一种比较有效性模型.
- 使用AudioScan Verifit 2测试盒软件评估了安全性和有效性.
- 在三个音量输入处分析了三种听力损失模式 (下坡,急剧下坡,逆坡).
主要成果:
- 处方听力助听器显示出更好的安全性,特别是在8000Hz下坡听力损失模式.
- 处方药在三个测试点上显示出具有统计学意义的优势.
- 一般来说,OTC助听器在测试和目标输出水平之间存在较大的差异.
结论:
- 发现OTC和处方助听器相对安全.
- 据观察,OTC助听器的效果略低于处方药的助听器.
- 建议对OTC助听器的有效性进行进一步的研究,以确保对各种类型的听力损失提供足够的益处.
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