Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus

耳鸣-定义为耳鸣、嗡嗡声或其他耳朵或头部的声音-是最普遍的服务- 退伍军人中的相关残疾。耳鸣影响10%-15%的成年人口。对于其中约20%的人， 耳鸣在睡眠障碍、注意力不集中和/或情绪方面影响他们的生活 反应。这20%是最需要临床服务的。已经证明，提供放大 通过助听器为听力损失的人也可以有益于减少耳鸣的功能影响， 大概是因为放大环境声音降低了耳鸣和 背景音，使耳鸣更容易被忽视。有越来越多的报道来自 提供助听器的听力专家领域将为烦人的患者提供低增益放大 耳鸣谁不是其他助听器候选人，与有益的结果。然而，这一非传统的 适配实践尚未经过正式评估，因此没有研究证据支持这一实践。它是 退伍军人管理局必须提供支持这些做法的证据，以证明这些设备的使用(和费用)是合理的 对于原本没有资格接受助听器的患者。 拟议的项目是一项先导性研究，将为未来的完全随机对照试验奠定基础。 (RCT)评估低增益放大技术在听力正常患者中治疗烦人耳鸣的应用。一个 20名听力阈值正常但有烦人耳鸣的退伍军人飞行员样本将适合轻度耳鸣 通过管道内接收器助听器进行放大。助听器将被编程为提供低- 扩增水平，使用NAL-NL2指南进行目标增益。将对结果度量进行预匹配评估 在两个随访时间点(适配后2周和3个月)进行适配。结果将包括耳鸣 成人功能指数(TFI)、听力障碍评定量表(HHIA)与噪声中的快速语音 (QuickSIN)测试。将助听器配戴前后的结果进行比较，以评估助听器是否 在耳鸣和听力结果方面为参与者提供了好处。此外，参与者将是 在最近一次访问中接受采访，以了解他们自报从助听器中受益的情况以及任何障碍 他们遇到戴助听器的困难. 此外，还将通过电话采访一组退伍军人管理局的临床听力专家。这些临床医生将是 通过发送给退伍军人管理局听力学专家电子邮件组的电子邮件调查确定，询问他们是否提供低- 对听力正常患者的烦人耳鸣的增益放大。这项调查还将询问听力学家 如果他们愿意参加一次简短的电话面试，就可以做志愿者。目标将是确定至少10个 以这种方式安装助听器的听力专家，以及多达五名不是这样的人。这些听觉学家将成为 通过电话采访，了解他们为什么将这一点纳入他们的临床实践中(或为什么 他们没有)，并询问具体的匹配程序和标准，以确定他们 都用过。这些答复将向议定书通报未来的随机对照试验。 在本项目结束时，将收集足够的信息来提出低收益的对照研究 听力正常的人中烦人的耳鸣的放大。该项目的议定书将是 由试点方案的成功方面以及退伍军人管理局临床医生的意见提供信息，这些医生 在野外做这件事。对这些助听器提供的益处的初步评估将提供理由 进行一项大型对照研究。最后，试点数据将为功率计算提供基础，以确定 样本大小，以及对流失率的估计，以充分调整自然减员。完整的RCT演示 低增益放大对听力正常的烦人耳鸣的疗效将提供所需的 支持临床实践的证据已经在退伍军人事务部内外获得了一些吸引力。 需要强有力的研究证据来支持这一做法的继续和未来的扩展。

Tinnitus – defined as ringing, humming, or other sounds in the ears or head – is the most prevalent service- connected disability among Veterans. Tinnitus affects 10-15% of the adult population. For about 20% of these, tinnitus impacts their lives with respect to sleep disturbance, impaired concentration, and/or emotional reactions. These 20% are the most in need of clinical services. It has been shown that providing amplification via hearing aids for people with hearing loss can also be beneficial in reducing functional effects of tinnitus, presumably because amplifying environmental sounds reduces the contrast between the tinnitus and background sound, allowing the tinnitus to be more easily ignored. There have been increasing reports from the field of audiologists providing hearing aids set to deliver low-gain amplification on patients with bothersome tinnitus who are not otherwise hearing aid candidates, with beneficial outcomes. However, this nontraditional fitting practice has not been formally evaluated, so there is no research evidence to support the practice. It is essential for VA to show evidence supporting such practices to justify the use (and expense) of these devices with patients who otherwise do not qualify to receive hearing aids. The proposed project is a pilot study that would lay the groundwork for a future full randomized controlled trial (RCT) evaluating the use of low-gain amplification for bothersome tinnitus in patients with normal hearing. A pilot sample of 20 Veterans with normal hearing thresholds and bothersome tinnitus will be fit with mild amplification through receiver-in-the-canal hearing aids. Hearing aids will be programmed to provide a low- level of amplification, using NAL-NL2 guidelines for target gain. Outcome measures will be evaluated pre-fit and post-fit at two follow-up time points (2 weeks and 3 months post-fit). Outcomes will include the Tinnitus Functional Index (TFI), Hearing Handicap Inventory for Adults (HHIA) and the Quick Speech in Noise (QuickSIN) test. Outcomes pre and post hearing aid fit will be compared to evaluate whether the hearing aids provided benefit to participants in terms of their tinnitus and hearing outcomes. Additionally, participants will be interviewed at their last visit to find out their self-reported benefit from the hearing aids, as well as any barriers they encountered to wearing the hearing aids. Additionally, a group of VA clinical audiologists will be interviewed by telephone. These clinicians will be identified via an email survey sent to the VA audiologist email group, asking whether they are providing low- gain amplification for bothersome tinnitus to patients with normal hearing. The survey will also ask audiologists to volunteer if they are willing to participate in a brief telephone interview. The aim will be to identify at least ten audiologists who are fitting hearing aids in this way, and up to five who are not. These audiologists will be interviewed over the telephone to find out why they have incorporated this into their clinical practice (or why they have not), and inquire about specific fitting procedures and criteria for identifying candidates that they have used. These responses will inform the protocol of the future RCT. At the conclusion of this project, enough information will be collected to propose a controlled study of low-gain amplification for bothersome tinnitus in people with normal hearing. The protocol for that project will be informed by both the successful aspects of the pilot protocol as well as the input from VA clinicians who are doing this in the field. A preliminary evaluation of benefit provided by these hearing aids will provide justification for a large controlled study. Finally, the pilot data will provide the basis for a power calculation to determine sample size, as well as an estimate of drop-out rate to sufficiently adjust for attrition. A full RCT demonstrating efficacy of low-gain amplification for bothersome tinnitus in people with normal hearing would provide needed evidence supporting a clinical practice that has already gained some traction both within and outside VA. Robust research evidence is needed to support the continuation and future expansion of this practice.