具有耳鸣声音发生器的市售听力仪器的上市前版本:在临床试验中进行评估的可行性。

Pre-market version of a commercially available hearing instrument with a tinnitus sound generator: feasibility of evaluation in a clinical trial.

作者信息

Sereda Magdalena, Davies Jeff, Hall Deborah A

机构信息

a National Institute for Health Research (NIHR), Nottingham Hearing Biomedical Research Unit , Nottingham , UK and.

b Otology and hearing group, Division of Clinical Neuroscience , University of Nottingham , Nottingham , UK.

出版信息

Int J Audiol. 2017 Apr;56(4):286-294. doi: 10.1080/14992027.2016.1254822. Epub 2016 Nov 25.

Abstract

OBJECTIVE

This report considers feasibility of conducting a UK trial of combination devices for tinnitus, using data from the study which evaluated different listener programmes available within the pre-market version of Oticon Alta with Tinnitus Sound Generator.

DESIGN

Open and closed questions addressed the following feasibility issues: (1) Participant recruitment; (2) Device acceptability; (3) Programme preferences in different self-nominated listening situations; (4) Usability; (5) Compliance; (6) Adverse events.

STUDY SAMPLE

Eight current combination hearing aid users (all males) aged between 62-72 years (mean age 67.25 years, SD = 3.8).

RESULTS

All eight participants reported the physical aspects and noise options on the experimental device to be acceptable. Programmes with amplification and masking features were equally preferred over the basic amplification-only programme. Individual preferences for the different programme options varied widely, both across participants and across listening situations.

CONCLUSIONS

A set of recommendations for future trials were formulated which calls for more "real world" trial design rather than tightly controlling the fitting procedure.

摘要

目的

本报告利用一项研究的数据,探讨在英国开展耳鸣组合设备试验的可行性,该研究评估了带有耳鸣声音发生器的奥迪康·阿尔塔上市前版本中可用的不同聆听程序。

设计

开放式和封闭式问题涉及以下可行性问题:(1)参与者招募;(2)设备可接受性;(3)在不同自我指定聆听情境下的程序偏好;(4)可用性;(5)依从性;(6)不良事件。

研究样本

八名年龄在62 - 72岁之间(平均年龄67.25岁,标准差 = 3.8)的当前组合式助听器使用者(均为男性)。

结果

所有八名参与者均报告实验设备的物理方面和噪音选项是可接受的。具有放大和掩蔽功能的程序比仅基本放大程序更受青睐。不同程序选项的个人偏好差异很大,无论是在参与者之间还是在聆听情境之间。

结论

制定了一套针对未来试验的建议,呼吁采用更“真实世界”的试验设计,而不是严格控制验配程序。

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