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临床试验/NCT06047639
NCT06047639已完成不适用

Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media

Pamukkale University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
World Health Organisation(WHO) Quality of Life Questionarie

研究概览

简要总结

The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in chronic otitis media patients

详细描述

Hearing loss is a significant disability that disrupts an individual's communication with others and can have a profound impact on their social life and career. It can lead to social isolation, depression, anxiety, and even early dementia. Chronic otitis is one of the most important ear diseases that can cause hearing loss. Its treatment is surgical, but sometimes even after surgery, hearing rehabilitation is needed. In such cases, the first option is the use of hearing aids. Some patients may be unable to use hearing aids due to excessive ear canal clearance, recurrent ear infections, or outer ear canal problems. In such cases, bone-anchored hearing devices emerge as the most logical option, although they are more costly compared to regular hearing aids. The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in the context of our country

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No difficulty in coming to the hospital for follow-up
  • Ability to communicate and express oneself at a level sufficient to interact with researchers
  • Having an indication for BAHI due to Chronic Otitis media

排除标准

  • Those with severe systemic illnesses (cancer, HIV, etc.)
  • Psychiatric patients experiencing compliance issues with hearing tests
  • Use of medication or medical devices that could affect the outcome of the study
  • Patients who cannot adhere to regular follow-ups and do not use the device will be excluded from the study.

结局指标

主要结局

World Health Organisation(WHO) Quality of Life Questionarie

时间窗: One year

Standard question list about the general health and quality of life of the patient

free field hearing level

时间窗: one year

Measuring hearing threshold with device on

Speech, Spatial and Qualities of Hearing Scale

时间窗: One year

Subjective evaluation of the hearing by questionaries

次要结局

  • Cost Benefit of the intervention(on year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fazıl Necdet Ardıç

Head of department of Otolaryngology

Pamukkale University

研究点 (1)

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