Audiological results of the middle ear implantation in patients with mixed hearing loss after the middle ear surgery: prospective multicenter study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
This study confirmed the improvement in the subjects' subjective satisfaction after the middle ear transplantation. Since the subjects of the study were patients who needed to use hearing aids but could not use them due to otorrhea or anatomical problems or did not get enough benefit from wearing conventional hearing aids, only direct comparison of hearing after wearing hearing aids and middle ear implantation had limitations in analyzing the effects of effect of the middle ear transplantation. There was a statistically significant difference of the K-IOI-HA score between the hearing aids and the middle ear implants. This means that for people with hearing loss who cannot wear hearing aids, the middle ear implantation is not just an alternative method for hearing aids, but also a superior technology that provides greater satisfaction. The incidence of complications related to middle ear implantation was not high, but one case developed a surgical site infection that required removal of the middle ear implant. Additional studies for the frequency of postoperative complications in a larger number of patients are needed.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •?An adult patient aged 20-80 years who underwent mastoidectomy and tympanoplasty with chronic otitis media (including chronic otitis media with cholesteatoma)
- •?Patient with bone conduction hearing threshold of 25dB or higher and mean air-bone gap of 25dB or higher in mixed hearing loss ear, air conduction threshold of 45dB or higher in other side
- •?Patient with PBmax over 50% in speech audiometry
- •?Difficult to expect hearing improvement with ossiculoplasty
- •?Patient who do not get enough gain in wearing a general hearing aid or difficult to wear a hearing aid because of otorrhea or change in the shape of the external auditory canal
- •?No contraindication to general anesthesia
- •?Patient who agrees to participate in the clinical study and have signed a written consent form him/herself
排除标准
- •?Those who are illiterate or unable to read the written consent of a foreigner or have difficulty understanding the clinical trial due to mental retardation
- •?Patients who do not have residual hearing or whose speech discrimination score is less than 50% are not expected to have hearing improvement even after middle ear implantation
- •?Patients who do not have residual hearing and who are indication for cochlear implants
- •?Patients who are expeected to impreve hearing even by using hearing aids
- •?Patients with suspected anomalies of inner ear and cochlear nerve pathway and requiring other method of treatment
- •?Patients judged to be inappropriate for this clinical trial by the judgement of the investigator