Cebulla Mario, Shehata-Dieler Wafaa
Comprehensive Hearing Center (CHC), Department of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, Julius Maximilian-University Hospitals, Würzburg, Germany.
Int J Pediatr Otorhinolaryngol. 2012 Apr;76(4):536-43. doi: 10.1016/j.ijporl.2012.01.012. Epub 2012 Feb 5.
At our center, the Maico MB11 BERAphone(®) device is used for newborn hearing screening based on Auditory Brainstem Responses (ABR). In 2006, an optimized chirp stimulus was implemented in the device to increase the reliability and quality of the screening method. In 2002, an automated response detection algorithm had been implemented. This study analyzes the screening results using the MB11 BERAphone(®) device with the implemented chirp stimulus and automated response detection method.
The data presented were collected in the well-baby nursery as part of the newborn hearing screening program following a two stage screening protocol. To focus the study on the typical routine screening, data from at-risk babies were not included. Overall, data from 6866 babies (3604 males and 3262 females) screened from March 2006 to April 2011 were analyzed in this study.
Out of the 6866 babies screened, 6607 passed bilaterally prior to hospital discharge (defined as 1st stage in this hearing screening program). Therefore, the pre-discharge pass rate of the hearing screening with the MB11 BERAphone(®) device was 96.2%. The resulting referral rate was 3.8%. The median test time per ear (excluding time for preparation and data reporting) was 28s with a range of 15-112s (5-95th percentile). The number of infants referred for 2nd stage, post-discharge re-screening was 259. Of this group, 71 passed bilaterally and 188 failed the re-screening in one or both ears. Therefore, including both the pre-discharge and post-discharge screening results, the bilateral pass rate was 97.3% and 2.7% were referred for diagnostic evaluation. Diagnostic testing was performed on all of the 188 infants who were referred. Results showed that 47 of these babies had hearing loss. This equates to a positive predictive value for a refer result of 25%. The observed prevalence of hearing impairment in our population was 0.684%. Diagnostic results for 141 of the referred newborns proved that they had normal hearing. That is, 141 out of 6866 newborns had a false-positive result with the MB11 BERAphone(®) screening. Therefore, the device had a specificity of 97.9%. During the time period of this study, no baby who passed the hearing screening was later found to have hearing impairment, suggesting a sensitivity of 100%. However, due to the limited number of newborns and the short time period after screening for the more recently screened babies, a reliable estimate of the sensitivity cannot be yet made from our program statistics. The theoretical sensitivity of the MB 11 device is 99.9%.
The Maico MB11 BERAphone(®) is a reliable device for auditory brainstem response newborn hearing screening and it provides results within a very short time. Due to the implemented method for automatic detection of ABR, the use of the device does not require an experienced examiner, allowing it to be used by trained technicians in locations outside the department of audiology such as the well-baby nursery.
在我们中心，迈科MB11听觉脑干反应测听仪（BERAphone®）用于基于听觉脑干反应（ABR）的新生儿听力筛查。2006年，该设备采用了优化的啁啾刺激，以提高筛查方法的可靠性和质量。2002年，已实施自动反应检测算法。本研究分析了使用带有已实施啁啾刺激和自动反应检测方法的MB11听觉脑干反应测听仪（BERAphone®）的筛查结果。
所呈现的数据是在健康婴儿护理室收集的，作为新生儿听力筛查项目的一部分，遵循两阶段筛查方案。为使研究聚焦于典型的常规筛查，未纳入高危婴儿的数据。总体而言，本研究分析了2006年3月至2011年4月期间筛查的6866名婴儿（3604名男性和3262名女性）的数据。
在筛查的6866名婴儿中，6607名在出院前双耳通过（在本听力筛查项目中定义为第一阶段）。因此，使用迈科MB11听觉脑干反应测听仪（BERAphone®）进行听力筛查的出院前通过率为96.2%。转诊率为3.8%。每只耳朵的中位测试时间（不包括准备和数据报告时间）为28秒，范围为15 - 112秒（第5 - 95百分位数）。转诊至第二阶段、出院后重新筛查的婴儿数量为259名。在这一组中，71名双耳通过，188名一只或两只耳朵重新筛查未通过。因此，包括出院前和出院后筛查结果，双耳通过率为97.3%，2.7%被转诊进行诊断评估。对所有188名被转诊的婴儿进行了诊断测试。结果显示，这些婴儿中有 47名有听力损失。这相当于转诊结果的阳性预测值为 25%。在我们的人群中观察到的听力障碍患病率为0.684%。对141名被转诊新生儿的诊断结果证明他们听力正常。也就是说，在6866名新生儿中，有141名使用迈科MB11听觉脑干反应测听仪（BERAphone®）筛查出现假阳性结果。因此，该设备的特异性为97.9%。在本研究期间，没有通过听力筛查的婴儿后来被发现有听力障碍，提示敏感性为100%。然而，由于新生儿数量有限以及对最近筛查婴儿筛查后的时间较短，我们项目的统计数据尚无法对敏感性做出可靠估计。MB11设备的理论敏感性为99.9%。
迈科MB11听觉脑干反应测听仪（BERAphone®）是用于听觉脑干反应新生儿听力筛查的可靠设备，并且能在极短时间内提供结果。由于实施了自动检测ABR的方法，该设备的使用不需要经验丰富的检查人员，允许经过培训的技术人员在听力科以外的地点使用，如健康婴儿护理室。
