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临床试验/NCT01264510
NCT01264510撤回4 期

The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness

University Hospital, Ghent1 个研究点 分布在 1 个国家开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles

研究概览

简要总结

A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear.

Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients.

Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patients (males and females) already implanted with a bone-anchored hearing aid (Baha) are included in the study.
  • Only patients above 18 years will be included.

排除标准

  • 未提供

结局指标

主要结局

benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles

时间窗: after 3 months up to 10 years

Patients who are already implanted with a Baha at the University Hospital of Ghent will be re-evaluated once using an audiological test battery. This evaluation will take place at least 3 months after implantation for the recently implanted subjects. For the subjects who are implanted in the past, this evaluation will take place maximum 10 years after implantation. The audiological test battery includes measurements of hearing thresholds, speech understanding in quiet and noise, and auditory orientation tests.

次要结局

  • evaluation of subjective benefit of the Baha(after 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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