Abstract：
OBJECTIVE: The current study employed a skull-simulator verification method to assess whether the output of softband bone conduction hearing devices (BCHDs) at the manufacturer\'s default settings deviated widely from the target determined by the fitting formula.
BACKGROUND: Real ear analysis is utilized for the verification of the fitting of air conduction hearing devices (ACHDs) in a variety of institutions. This procedure, however, has not been used in the fitting of BCHDs, largely due to the difficulty of testing the output of these devices to temporal bones. Despite the availability of skull simulators, they have not been utilized clinically to measure BCHD output.
METHODS: This prospective, single-center study enrolled 42 subjects, aged 3 months to 10 years, with microtia-atresia-associated mild-to-severe bilateral conductive hearing loss. Hearing sensitivity was evaluated behaviorally by pure tone audiometry (PTA) in 22 subjects 4 years or older (the PTA group), and by auditory brainstem response (ABR) in 20 subjects younger than 4 years (the ABR group). Following 6 months of subjects wearing the prescribed softband BCHDs, their dial level (DL) thresholds were reassessed while using their own BCHDs, configured with zero gain across all frequencies, functioning solely as a bone vibrator. These DL thresholds were inputted into the fitting formula, desired sensation level-bone conduction devices (DSL-BCD) for children, to obtain the target values of BCHD output. The simulator output of the BCHD programmed at the manufacturer\'s default setting was measured in response to speech presented at 55, 65, and 80 dB SPL, followed by gain adjustment based on the differences between the simulator output and the target. Aided speech intelligibility index (SII) was measured before and after the gain adjustment.
RESULTS: The softband BCHDs at the manufacturer\'s settings generally had lower output than the prescribed target values. This difference was larger at low frequencies and low levels. Across the 12 points tested (four frequencies from 500 to 4000 Hz multiplied by three levels), 22 (52.3%) and 42 (100%) BCHDs had deviations of +7 and +5 dB, respectively, at one point or more. The gain adjustments reduced the deviation and improved the SII values at the two lower levels of speech presented.
CONCLUSIONS: The simulator output of softband bone conduction hearing devices (BCHDs) with the manufacturer\'s settings may exhibit significant deviations from the formula. Objective output verification should be considered a beneficial step in BCHD fitting and is recommended when applicable.
BACKGROUND: Real ear analysis is utilized for the verification of the fitting of air conduction hearing devices (ACHDs) in a variety of institutions. This procedure, however, has not been used in the fitting of BCHDs, largely due to the difficulty of testing the output of these devices to temporal bones. Despite the availability of skull simulators, they have not been utilized clinically to measure BCHD output.
METHODS: This prospective, single-center study enrolled 42 subjects, aged 3 months to 10 years, with microtia-atresia-associated mild-to-severe bilateral conductive hearing loss. Hearing sensitivity was evaluated behaviorally by pure tone audiometry (PTA) in 22 subjects 4 years or older (the PTA group), and by auditory brainstem response (ABR) in 20 subjects younger than 4 years (the ABR group). Following 6 months of subjects wearing the prescribed softband BCHDs, their dial level (DL) thresholds were reassessed while using their own BCHDs, configured with zero gain across all frequencies, functioning solely as a bone vibrator. These DL thresholds were inputted into the fitting formula, desired sensation level-bone conduction devices (DSL-BCD) for children, to obtain the target values of BCHD output. The simulator output of the BCHD programmed at the manufacturer\'s default setting was measured in response to speech presented at 55, 65, and 80 dB SPL, followed by gain adjustment based on the differences between the simulator output and the target. Aided speech intelligibility index (SII) was measured before and after the gain adjustment.
RESULTS: The softband BCHDs at the manufacturer\'s settings generally had lower output than the prescribed target values. This difference was larger at low frequencies and low levels. Across the 12 points tested (four frequencies from 500 to 4000 Hz multiplied by three levels), 22 (52.3%) and 42 (100%) BCHDs had deviations of +7 and +5 dB, respectively, at one point or more. The gain adjustments reduced the deviation and improved the SII values at the two lower levels of speech presented.
CONCLUSIONS: The simulator output of softband bone conduction hearing devices (BCHDs) with the manufacturer\'s settings may exhibit significant deviations from the formula. Objective output verification should be considered a beneficial step in BCHD fitting and is recommended when applicable.
摘要：
目的：当前的研究采用了颅骨模拟器验证方法来评估制造商默认设置下的软带骨传导听力设备（BCHD）的输出是否与拟合公式确定的目标有很大偏差。
背景：实耳分析用于验证各种机构中的空气传导听力设备（ACHD）的装配。这个程序,然而,尚未用于BCHD的装配，很大程度上是由于测试这些设备输出到颞骨的难度。尽管有头骨模拟器,它们尚未用于临床测量BCHD输出。
方法：这种前瞻性，单中心研究纳入42名受试者，3个月至10岁，与小耳畸形闭锁相关的轻度至重度双侧传导性听力损失。通过纯音测听法（PTA）对22名4岁或以上的受试者（PTA组）进行行为评估，以及20名年龄小于4岁的受试者（ABR组）的听觉脑干反应（ABR）。在受试者佩戴规定的软带BCHD6个月后，在使用自己的BCHD时重新评估了他们的拨号水平（DL）阈值，在所有频率上配置为零增益，仅用作骨骼振动器。这些DL阈值被输入到拟合公式中，儿童所需的感觉水平骨传导设备（DSL-BCD），获取BCHD输出的目标值。在制造商默认设置下编程的BCHD的模拟器输出响应于在55、65和80dBSPL下呈现的语音进行测量，然后根据模拟器输出和目标之间的差异进行增益调整。在增益调整之前和之后测量辅助语音清晰度指数（SII）。
结果：制造商设置下的软带BCHD的输出通常低于规定的目标值。这种差异在低频率和低水平下更大。在12个测试点（从500到4000Hz的四个频率乘以三个级别），22(52.3%)和42(100%)BCHD的偏差为+7和+5dB，分别,在一个点或更多。增益调整减小了偏差并改善了所呈现的两个较低语音级别处的SII值。
结论：具有制造商设置的软带骨传导听力设备（BCHD）的模拟器输出可能会显示出与公式的显着偏差。客观输出验证应被视为BCHD拟合的有益步骤，并在适用时推荐。
背景：实耳分析用于验证各种机构中的空气传导听力设备（ACHD）的装配。这个程序,然而,尚未用于BCHD的装配，很大程度上是由于测试这些设备输出到颞骨的难度。尽管有头骨模拟器,它们尚未用于临床测量BCHD输出。
方法：这种前瞻性，单中心研究纳入42名受试者，3个月至10岁，与小耳畸形闭锁相关的轻度至重度双侧传导性听力损失。通过纯音测听法（PTA）对22名4岁或以上的受试者（PTA组）进行行为评估，以及20名年龄小于4岁的受试者（ABR组）的听觉脑干反应（ABR）。在受试者佩戴规定的软带BCHD6个月后，在使用自己的BCHD时重新评估了他们的拨号水平（DL）阈值，在所有频率上配置为零增益，仅用作骨骼振动器。这些DL阈值被输入到拟合公式中，儿童所需的感觉水平骨传导设备（DSL-BCD），获取BCHD输出的目标值。在制造商默认设置下编程的BCHD的模拟器输出响应于在55、65和80dBSPL下呈现的语音进行测量，然后根据模拟器输出和目标之间的差异进行增益调整。在增益调整之前和之后测量辅助语音清晰度指数（SII）。
结果：制造商设置下的软带BCHD的输出通常低于规定的目标值。这种差异在低频率和低水平下更大。在12个测试点（从500到4000Hz的四个频率乘以三个级别），22(52.3%)和42(100%)BCHD的偏差为+7和+5dB，分别,在一个点或更多。增益调整减小了偏差并改善了所呈现的两个较低语音级别处的SII值。
结论：具有制造商设置的软带骨传导听力设备（BCHD）的模拟器输出可能会显示出与公式的显着偏差。客观输出验证应被视为BCHD拟合的有益步骤，并在适用时推荐。
