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临床试验/NCT00201617
NCT00201617已完成不适用

Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness

The New York Eye & Ear Infirmary1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Localization

研究概览

简要总结

The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness

详细描述

Limited studies have been done on the BAHA in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. The findings of the limited number of studies to date on the BAHA with single sided deafness demonstrate that the BAHA improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the BAHA to have at least satisfactory benefit. But conflicting findings have been obtained regarding whether the BAHA improves the ability to locate the source of a sound. Additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity.

This investigation will show whether the previously reported BAHA benefits at one month post BAHA sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post BAHA sound processor fitting. This long-term investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect on localization abilities.

Subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the BAHA.In order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult-onset deafness
  • Deafness is unilateral - complete or near complete

排除标准

  • the presence of a developmental disorder or mental retardation;
  • history of drug abuse;
  • psychiatric disease;
  • inability to follow instructions or to participate in follow-up appointments
  • inability to use the BAHA
  • lack of osseo-integration -

结局指标

主要结局

Localization

时间窗: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA

Localization in sound field test

HINT score

时间窗: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA

Hearing in Noise Test

CNC score

时间窗: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA

Consonant-nucleus-consonant speech-recognition test

次要结局

  • Abbreviated Profiles of Hearing Aid Benefit(3 months post BAHA, 6 months post BAHA, 1 year post BAHA)

研究者

申办方类型
Other

研究点 (1)

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