临床证据证实Vivosonic技术的优势

来自独立研究人士和在听力学领域领先专家的临床证据验证了Vivosonic技术的优势，并论证了Integrity™V500系统比传统的AEP设备的实质优势。

下面的调查结果从英语出版物翻译得出。如需查看英文摘要、文章和介绍，请参阅文章和介绍。

Vivosonic技术的优势

临床证据

Integrity减少镇静的需要

高达66-92% 3,4

Integrity降低医疗成本

至少降低85% 3

每个病人降低达到 $5000 USD 5,6

Integrity减少ABR评估等待时长

从 原来的> 2 个月缩短到< 3周。1,3

从 5-6 个月到 1周。4

Integrity对普适新生儿听力筛查的转介有显著影响

增大住院婴儿完成诊断测试的可能性。1

减少了后续跟进的需要。可以测试稍大清醒的婴儿。4

相对于传统的AEP系统，Integrity不易受生理噪声影响

在50-60分贝peSPL（~15-25分贝nHL）马达稳态噪声条件下有显著优势，获得响应的概率要高30-44%。在婴儿清醒时可启动测试并在20或30分贝 nHL.5 获得V波。5

在4千赫的噪声阈值（生理）更加可靠 - 相比其他竞争产品有更少的“无回应。7

在“活动”状态下，Vivosonic比传统设备让更多的受测者获得正常的V波阈值。8

Integrity不容易受电伪影影响

在4/5的情况下，Integrity比传统的AEP系统在NICU显示出较低的（更好的）阈值。9

在NICU ABR有效地测试降低电器和肌肉伪迹。不必为进行新生儿听力筛查而改变环境。10

Integrity更有效地获得听觉阈值评估

ABR评估平均时长减少至1小时20分钟。不再需要预约3个小时的门诊。1

对浅眠或清醒的婴儿进行双耳多频气导和骨导阈值测试，需要的时间不到1.5小时，且已包括其他活动的时间。11

Integrity准确地测量听力阈值，并提供有助于临床决策的信息

促成超过90％的非镇静案例的管理决策。3

在95％的耳测试中，与临床决策一致或达到更好效果。9

气导和短纯音ABR阈值反应类似于测量精度的常规设备所公布的调查结果。11

40赫兹sASSR和TB-ABR准确地检测4000赫兹时在5-10分贝范围内行为阈值的阈值。15

Integrity可对难以测试人群进行有效测试

是对行为模式难以测试的儿童进行有效测试的筛查装置。筛查完成率实现从57%（只有行为）到81%（行为和ABR筛查）的显著增长。12

使用短声和500赫兹的短纯音刺激（无镇静） 对脑性瘫痪患者测试可获得较高的成功率。13

真正由噪音引起的听力缺失者可以和那些装病的人区分开来。用其他的ABR系统，装病的病人能够无限期地拖延反应，提升其阈值到他们可以领取保险金的水平。14


参考资料

1.

Walker B (2012). Clinical Significance of Advanced ABR Technology for Newborn Hearing Screening Programs.

2.

Marcoux A, Kurtz I (2013). Noise Reduction to Achieve Quality ABR Measurement.

3.

Hall JW III, Sauter T (2010). Clinical Experience with New Technology For Recording Un-Sedated ABRs.

4.

Sebzda JM (2010). Pediatric ABR testing without sedation? Is it possible?

5.

Cone B, Norrix LW. University of Arizona. "Measuring the Advantage of Kalman-Weighted Averaging for Auditory Brainstem Response Hearing Evaluation in Infants". American Journal of Audiology, 2015 Jun;24(2):153-68.

6.

Cone B, Dean J, Norrix L, Velenovsky D (2013). Innovations in the Electrophysiologic Assessment of Infant Hearing: Cost Model.

7.

Wheeler JK (2011). The Effect of Kalman Weighted Filtering and In-situ Pre-amplification on the Accuracy and Efficiency of ABR Threshold Estimation.

8.

Meyer D, Moskop J, Winston A, Schupbach J (2011). ABR Results in Quiet and Active Subjects.

9.

Brown DK, Hunter LL, Baroch K, Eads E (2011). Comparison of Auditory Brainstem Response Systems in the NICU Population.

10.

Johnson K (2012). Universal Newborn Hearing Screening in the NICU Population Using New Features of the Vivosonic Integrity ABR Unit: Assessing the Correlation Coefficient as a Function of the Number of Sweeps Collected.

11.

Elsayed AM, Hunter LL, Keefe DH, Feeney MP, Brown DK, Meinzen-Derr JK, Baroch K, Sullivan-Mahoney M, Francis K, Schaid LG. Cincinnati Children's Hospital Medical Center. "Air and Bone Conduction Click and Tone-Burst Auditory Brainstem Thresholds Using Kalman Adaptive Processing in Nonsedated Normal-Hearing Infants." Ear and Hearing, 2015 Jul-Aug;36(4):471-81.

12.

Wiegers JS, Bielefeld EC, Whitelaw GM. The Ohio State University. "Utility of the Vivosonic Integrity™ auditory brainstem response system as a hearing screening device for difficult-to-test children". International Journal of Audiology, 2015 Apr;54(4):282-8.

13.

Van der Westhuizen C (2010). The Clinical Utility of the Vivosonic Integrity Auditory Brainstem Response System in Children with Cerebral Palsy.

14.

Steinman A, Holdstein Y (2013). Use of the Vivosonic Integrity V500 System to Identify False Indications of Noise Induced Hearing Loss.

15.

Kaf WA, Mohamed ES, Elshafiey H (2016). 40-Hz Sinusoidal Auditory Steady-State Response and Tone Burst Auditory Brainstem Response Using a Kalman Filter to Determine Thresholds Pre- and Post-Myringotomy With Grommet Tube in Children With Mild, Low-Frequency Conductive Hearing Loss. Am J Audiol, 2016 Mar;25(1):41-53.