Ont Health Technol Assess Ser. 2002;2(3):1-47. Epub 2002 Sep 1.
The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of bone-anchored hearing aid (BAHA) in improving the hearing of people with conduction or mixed hearing loss.
The (BAHA) is a bone conduction hearing device that includes a titanium fixture permanently implanted into the mastoid bone of the skull and an external percutaneous sound processor. The sound processor is attached to the fixture by means of a skin penetrating abutment. Because the device bypasses the middle ear and directly stimulates the cochlea, it has been recommended for individuals with conduction hearing loss or discharging middle ear infection. The titanium implant is expected to last a lifetime while the external sound processor is expected to last 5 years. The total initial device cost is approximately $5,300 and the external sound processor costs approximately $3,500. REVIEW OF BAHA BY THE MEDICAL ADVISORY SECRETARIAT: The Medical Advisory Secretariat's review is a descriptive synthesis of findings from 36 research articles published between January 1990 and May 2002.
No randomized controlled studies were found. The evidence was derived from level 4 case series with relative small sample sizes (ranging from 30-188). The majority of the studies have follow-up periods of eight years or longer. All except one study were based on monaural BAHA implant on the side with the best bone conduction threshold.
Level 4 evidence showed that BAHA has been be implanted safely in adults and children with success rates of 90% or higher in most studies. No mortality or life threatening morbidity has been reported. Revision rates for tissue reduction or resiting were generally under 10% for adults but have been reported to be as high as 25% in pediatric studies. Adverse skin reaction around the skin penetration site was the most common complication reported. Most of these conditions were successfully treated with antibiotics, and only 1% to 2% required surgical revision. Less than 1% required removal of the fixture. Other complications included failure to osseointegrate and loss of fixture and/or abutment due to trauma or infection.
Studies showed that BAHAs were implanted in people who have conduction or mixed hearing loss, congenital atresia or suppurative otitis media who were not candidates for surgical repair, and who cannot use conventional bone conduction hearing aids. The need for BAHA is not age- related. Objective audiometric measures and subjective patient satisfaction surveys showed that BAHA significantly improved the unaided and aided free field and sound field thresholds as well as speech discrimination in quiet and in noise for former users of conventional bone conduction hearing aids. The outcomes were ambiguous for former users of air conduction hearing aids. BAHA has been shown to reduce the frequency of ear infection and reduce the discharge particularly among patients with suppurative otitis media. Patients have reported that BAHA improved their quality of life. Reported benefits were improved speech intelligibility, better sound comfort, less pressure on the head, less skin irritation, greater cosmetic acceptance and increase in confidence. Main reported shortcomings were wind noise, feedback and difficulty in using the telephone. Experts and the BAHA manufacturer recommended that recipients of a BAHA implant be at least 5 years old. Challenges associated with the implantation of BAHA in pediatric patients include thin bone, soft bone, higher rates of fixture loss due to trauma, psychological problems, and higher revision rates due to rapid bone growth. The overall outcomes are comparable to adult BAHA. The benefits of pediatric BAHA (e.g. on speech development) appear to outweigh the disadvantages. Screening according to strict eligibility criteria, preoperative counselling, close monitoring by a physician with BAHA expertise and on-going follow-up were identified as critical factors for long-term implant survival. Examples of eligibility criteria were provided.
COST-EFFECTIVENESS: No literature on cost-effectiveness of BAHA was found.
本卫生技术政策评估的目的是确定骨锚式助听器（BAHA）在改善传导性或混合性听力损失患者听力方面的有效性和成本效益。
BAHA是一种骨传导听力设备，包括一个永久植入颅骨乳突骨的钛制固定装置和一个外部经皮声音处理器。声音处理器通过皮肤穿透式基台连接到固定装置上。由于该设备绕过中耳并直接刺激耳蜗，因此被推荐用于传导性听力损失或中耳感染流脓的个体。钛植入物预计可使用终身，而外部声音处理器预计可使用5年。设备初始总成本约为5300美元，外部声音处理器成本约为3500美元。医学咨询秘书处对BAHA的审查：医学咨询秘书处的审查是对1990年1月至2002年5月期间发表的36篇研究文章的结果进行的描述性综合。
未找到随机对照研究。证据来自4级病例系列，样本量相对较小（范围为30 - 188）。大多数研究的随访期为八年或更长。除一项研究外，所有研究均基于在骨传导阈值最佳一侧进行的单耳BAHA植入。
4级证据表明，BAHA已在成人和儿童中安全植入，大多数研究中的成功率达到90%或更高。未报告有死亡或危及生命的发病情况。成人组织减少或重新定位的翻修率通常低于10%，但儿科研究报告的翻修率高达25%。皮肤穿透部位周围的皮肤不良反应是报告的最常见并发症。这些情况大多通过抗生素成功治疗，只有1%至2%需要手术翻修。不到1%需要移除固定装置。其他并发症包括骨整合失败以及因创伤或感染导致固定装置和/或基台丢失。
研究表明，BAHA植入于传导性或混合性听力损失、先天性耳道闭锁或化脓性中耳炎且不适合手术修复以及无法使用传统骨传导助听器的患者。对BAHA的需求与年龄无关。客观听力测量和患者主观满意度调查表明，对于传统骨传导助听器的前使用者，BAHA显著改善了无助听和有助听时的自由声场和扩声场阈值以及安静和嘈杂环境中的言语辨别能力。对于气导助听器的前使用者，结果不明确。BAHA已被证明可减少耳部感染频率并减少流脓，特别是在化脓性中耳炎患者中。患者报告BAHA改善了他们的生活质量。报告的益处包括言语清晰度提高、声音舒适度更好、头部压力减轻、皮肤刺激减少、外观接受度更高以及自信心增强。报告的主要缺点是风噪、反馈和使用电话困难。专家和BAHA制造商建议BAHA植入接受者至少5岁。在儿科患者中植入BAHA相关的挑战包括骨质薄、骨质软、因创伤导致固定装置丢失率较高、心理问题以及因骨骼快速生长导致翻修率较高。总体结果与成人BAHA相当。儿科BAHA的益处（如对言语发育的影响）似乎超过了缺点。根据严格的入选标准进行筛查、术前咨询、由具有BAHA专业知识的医生进行密切监测以及持续随访被确定为长期植入物存活的关键因素。提供了入选标准的示例。
未找到关于BAHA成本效益的文献。
