A multisite study to examine the efficacy of the otoacoustic emission/automated auditory brainstem response newborn hearing screening protocol: introduction and overview of the study

PURPOSE: This article is the 1st in a series of 4 articles on a recently completed multistate study of newborn hearing screening. METHOD: The study examined the efficacy of the 2-stage otoacoustic emission/automated auditory brainstem response (OAE/A-ABR) protocol for identifying hearing loss in newborns. RESULTS: The study found that the 2-stage OAE/A-ABR protocol did miss a significant number of babies who exhibited a permanent hearing loss by 1 year of age. Three subsequent articles will describe the research design and results in detail, discuss the behavioral assessment of infants, and summarize the implications of the study for policy, practice, and research.     

A multisite study to examine the efficacy of the otoacoustic emission/automated auditory brainstem response newborn hearing screening protocol: recommendations for policy, practice, and research

PURPOSE: This article examines whether changes in hearing screening practices are warranted based on the results of the recent series of studies by J. L. Johnson, K. R. White, J. E. Widen, J. S. Gravel, B. R. Vohr, M. James, T. Kennalley, A. B. Maxon, L. Spivak, M. Sullivan-Mahoney, Y. Weirather, and S. Meyer (Johnson, White, Widen, Gravel, James, et al., 2005; Johnson, White, Widen, Gravel, Vohr, et al., 2005; White et al., 2005; Widen et al., 2005) that found a significant number of infants who passed an automated auditory brainstem response (A-ABR) screening after failing an initial otoacoustic emission (OAE) screening later were found to have permanent hearing loss in one or both ears. METHOD: Similar to the approach used by F. H. Bess and J. Paradise (1994), this article addresses the public health tenets that need to be in place before screening programs, or in this case, a change in screening practice (use of a 2-step screening protocol) can be justified. RESULTS: There are no data to suggest that a 2-step OAE/A-ABR screening protocol should be avoided. CONCLUSION: Research is needed before any change in public policy and practice surrounding current early hearing detection and intervention programs could be supported.     

A model of two-stage newborn hearing screening with automated auditory brainstem response

Our purpose was to evaluate a two-stage newborn hearing screening program using automated auditory brainstem response (AABR) before discharge and to describe our follow-up program. This study used 4085 infants born in the Seirei-Hamamatsu and Mikatahara General Hospitals during a 2-year period. The initial screening test was performed 2 or 3 days after birth at an intensity of 35 dBnHL. For the infants who were referred from this test, the re-screening test was performed 5 or 6 days after birth. Diagnostic work-up with auditory brainstem response (ABR), otoacoustic emissions (OAE), and a conditioned orientation reflex audiometry (COR) test were performed by the age of 3-6 months. The referral rate was 1.20% (49/4085 infants) in the first test and 0.71% (29/4085 infants) in the two-stage screening. The two-stage screening procedure was able to reduce the false-positive rate from 0.83 to 0.34%. The incidence of bilateral and unilateral congenital hearing loss diagnosed by ABR was 8/4085 (0.20%) infants and 7/4085 (0.17%) infants, respectively. One infant with congenital cytomegalovirus infection, who passed the two-stage AABR tests, was diagnosed with hearing loss 1 month after birth, using ABR. The two-stage measurement of AABR is effective and time efficient due to significant decreases in the referral rate and the false-positive rate.     

Comparison of currently available devices designed for newborn hearing screening using automated auditory brainstem and/or otoacoustic emission measurements

OBJECTIVE: Suitability in clinical practise of three currently available devices designed for automated newborn hearing screening, one combining evoked otoacoustic emissions (EOAE) and automated auditory brain stem response (AABR), the Echoscreen-TDA from Fischer-Zoth, and two AABR screeners, the Algo 3 from Natus and the Beraphone MB11 from Maico, were tested prospectively. METHODS: Transiently evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) were measured in one ear of 150 healthy newborns using the Echoscreen-TDA. Three groups of 50 subjects each were tested additionally for AABR recordings either with Echoscreen-TDA, Algo 3 or Beraphone MB11. Measurements were performed after the second day of life. The following aspects were evaluated: (a) subject-instrumentation interface (b) test time (c) costs (unit price and costs for disposable material) and (d) pass rates. RESULTS: Connecting the subjects to the device was the easiest for EOAE measurements with the Echoscreen-TDA, followed by AABR recordings with the Algo 3 and Echoscreen-TDA and were most difficult with the Beraphone MB11. The median test time on one ear was less than 30 s for EOAE measurements and 4-5 min for AABR recordings. Costs for the equipment and for disposable material were lowest for the Echoscreen-TDA and Beraphone MB11, respectively and highest for the Algo 3. Pass rates were highest with 98% for AABR recordings using the Algo 3 and lowest with 92% for AABR recordings using the Beraphone MB11, but differences were not statistically significant. CONCLUSIONS: All tested devices can be used for universal neonatal hearing screening. It was easier to connect the subject to the device and measurements were quicker for OAE than for AABR measurements. Echoscreen-TDA combines the two techniques and had the lowest costs for the AABR equipment. Algo 3 had the highest costs for the equipment and for disposable material, but it was highly reliable, and both ears can be tested simultaneously. Connecting the subject was the most difficult with the Beraphone MB11, but there were no disposable supply costs.     

Mechanisms in noise-induced permanent hearing loss: an evoked otoacoustic emission and auditory brainstem response study

In this study 22 patients (44 ears) with noise-induced permanent hearing loss were audiologically evaluated using transient-evoked otoacoustic emissions (TEOAE) and auditory brain-stem response (ABR). Twenty-one normal subjects (42 ears) without exposure to occupational noise were used as controls. Based upon the hearing loss at 4, 3, 2 and 1 kHz on the pure-tone audiogram, they were classified into four groups. In group 1 (eight ears), emissions were present in all ears but their TEOAE-noise level and their reproducibility (percentage) proved to be weak. The auditory brain-stem response (ABR) indicated that the I/V amplitude ratio, the latency values of wave V and the I-V intervals fell within the normal range in all ears. In Group 2 (14 ears), 40 per cent had no emissions, whereas the remaining ears showed weak emissions. The ABR revealed that in all ears the I/V amplitude ratio became small while wave V peak latency as well as I-V intervals were within the normal range. In Group 3 (10 ears), emissions were absent in 50 per cent, while in the other ears the emissions were very weak. The ABR revealed that the I/V amplitude ratio, which could be calculated in the 60 per cent in which wave I was present, was smaller than in Group 2. Wave V latency as well as I-V intervals were within the normal range. In Group 4 (12 ears), none of the ears showed emissions. The ABR indicated that the I/V amplitude ratio was much smaller when wave I was present (27 per cent) as well as I-V interval values being within the normal range. Wave V absolute latency value (delta V index) indicated a positive index in 17 per cent of this group (two ears) when wave I was absent. In the present study a dynamic process from cochlear outer hair cells to cochlear neurons was seen, correlating with an increasing hearing loss.     

A comparison of transient-evoked otoacoustic emissions and automated auditory brainstem responses for pre-discharge neonatal hearing screening

The aim of this study was to compare two hearing-screening methods in well newborn infants within the postnatal ward environment prior to discharge. Eighty-one newborn infants underwent one-step hearing screening by measurement of automated auditory brainstem responses (aABRs), using the ALGO-3 screener. These were compared with a further cohort of 81 neonates who underwent two-step screening using transient-evoked otoacoustic emissions (TEOAEs) followed by aABR. The pass rate was 78/81 (96.3%) for the one-step screen, 74/81 (91.4%) for the two-step screen, and 54/81 (66.7%) for TEOAE alone. There was no significant difference between cohorts in time required to complete the screening protocol. We conclude that pre-discharge hearing screening of newborn infants on the postnatal ward is feasible and acceptable. Use of TEOAE alone for pre-discharge screening is associated with an excessively high false-positive rate. At our institution, one-step screening resulted in a lower referral rate compared with a two-step approach. The performance of aABR screening may be affected by prior TEOAE screening.     

Comparison of two-step transient evoked otoacoustic emissions (TEOAE) and automated auditory brainstem response (AABR) for universal newborn hearing screening programs

OBJECTIVE: Both transitory auditory otoemissions (TEOAE) and automated auditory brainstem responses (AABR) are considered adequate methods for universal hearing screening. The goal of this study was to compare the results obtained with each device, applying the same screening procedure. MATERIALS AND METHODS: From 2001 to 2003, all the newborns in our health area (2454 infants) were evaluated with TEOAE (ILO92, otodynamics) and all those born from 2004 to 2006 (3117) were evaluated with AABR (AccuScreen, Fischer-Zoth). The population studied included all well newborns and those admitted to neonatal intensive care units (NICU). The first screening was normally undertaken with well babies during the first 48h of life, before hospital discharge. Infants referred from this first step underwent a second screening after hospital discharge, before they were a month old. RESULTS: The results from each study group were compared and analyzed for significant differences. TEOAE screening yielded 10.2% fail results from the first screening step; AABR gave 2.6%. In the second screening step, 2% of the newborns screened with TEOAE were referred, whereas 0.32% of those screened with AABR were referred. These differences are statistically significant. CONCLUSIONS: Although AABR screening tests involve a slightly higher cost in time and money than TEOAE, the results obtained compensate this difference. AABR gives fewer false positives and a lower referral rate; the percent of infants lost during follow-up is consequently smaller. Therefore, in our environment, universal newborn auditory screening with AABR is more effective than that with TEOAE.     

Predictive value of hearing assessment by the auditory brainstem response following universal newborn hearing screening

Abstract

Objective: This study set out to determine the accuracy with which tone pip ABR and click ABR, carried out in babies referred from universal newborn hearing screening, is able to predict the hearing outcome as determined by follow-up hearing tests. Study sample: The cohort of babies studied were all babies referred for hearing assessment from the universal newborn hearing screen in Sheffield, UK for the period January 2002 to September 2007, who were found to have a significant hearing impairment. Design: The results of hearing assessment following referral from the newborn hearing screen were collected together with those of follow-up tests carried out up to an age when behavioural testing had established ear- and frequency-specific thresholds at 0.5, 1, 2 and 4 kHz. Results: The standard deviation of the difference between the follow up and the tone pip ABR thresholds was 10.5 dB for the 4-kHz tone pip, 16.8 dB for the 1-kHz tone pip, and ranged between 21.7 and 24.7 dB for click ABR. Conclusions: The results of the study show that tone pip ABR following referral from newborn hearing screening has a similar accuracy to that reported in older subjects, and is a much better predictor compared to click ABR.     

Evaluation of an automated auditory brainstem response in a multi-stage infant hearing screening

An automated auditory brainstem response (AABR) method, the Maico MB-11 with BERAphone^®, has been developed for hearing screening in newborns. The aim of this study was to test the validity of this automated ABR screening method in a multistage newborn hearing screening (NHS). We applied a “five level” protocol using transient evoked otoacoustic emission (TEOAE), AABR-MB-11 with BERAphone^® and conventional auditory brainstem response (ABR). TEOAE, AABR, and conventional ABR testing were performed by ENT specialists experienced in neonatal screening techniques. Among the 8,671 newborns tested (males 3,889; females 4,782), only 42 newborns were lost to follow-up and the final false-positive rate was of 0.03%. Our experience highlights that for the neonatal period, conventional auditory brainstem response is the most reliable method for assessing the hearing level and minimizing the false-positive rate. Although AABR (performed by ENT specialists experienced in neonatal screening techniques) is easy to use, fast and with a good compliance, the device is unable to provide accurate and certain diagnosis on the degree of hearing loss to allow a proper treatment.     

Clinical evaluation of the vector algorithm for neonatal hearing screening using automated auditory brainstem response

A novel auditory brainstem response (ABR) detection and scoring algorithm, entitled the Vector algorithm is described. An independent clinical evaluation of the algorithm using 464 tests (120 non-stimulated and 344 stimulated tests) on 60 infants, with a mean age of approximately 6.5 weeks, estimated test sensitivity greater than 0.99 and test specificity at 0.87 for one test. Specificity was estimated to be greater than 0.95 for a two stage screen. Test times were of the order of 1.5 minutes per ear for detection of an ABR and 4.5 minutes per ear in the absence of a clear response. The Vector algorithm is commercially available for both automated screening and threshold estimation in hearing screening devices.     

Establishing normal hearing with the dichotic multiple-frequency auditory steady-state response compared to an auditory brainstem response protocol

OBJECTIVE: To determine the clinical usefulness of the dichotic multiple-frequency (MF) auditory steady-state response (ASSR) technique for estimating normal hearing compared to a 0.5-kHz tone burst and broadband click auditory brainstem response (ABR) protocol in a sample of adults. MATERIAL AND METHODS: A comparative experimental research design was selected in order to compare estimations of normal hearing obtained with the dichotic ASSR technique at 0.5, 1, 2 and 4 kHz with a 0.5-kHz tone burst and broadband click ABR protocol. The recording times required for each procedure were also compared. Normal-hearing subjects (n = 28) were selected according to immittance values within normal limits and pure-tone behavioural thresholds of < 25 dB HL across frequencies. RESULTS: The dichotic MF ASSR estimated normal hearing to be, on average, 30-34 dB HL across the range 0.5-4 kHz. The mean estimate of normal hearing for 0.5 kHz using tone burst ABRs was 30 dB nHL and the mean click ABR threshold was 16 dB nHL, i.e. 14-18 dB better than the ASSR thresholds. The dichotic MFASSR technique recorded 8 thresholds (4 in each ear) in a mean time of 23 min. The ABR protocol recorded 4 thresholds (2 in each ear) in a mean time of 25 min. CONCLUSION: Both the dichotic MF ASSR and ABR protocols provided a time-efficient estimation of normal hearing. There was no significant difference between the tone burst ABR and MF ASSR techniques in terms of estimation of normal hearing at 0.5 kHz. The dichotic MF ASSR technique proved more time-efficient by determining more thresholds in a shorter time compared to the ABR protocol.     

State of the art neonatal hearing screening with auditory brainstem response

The purpose of this paper is to briefly review some of the aspects of the auditory brainstem response (ABR) that are important in its use as a method of screening and assessing hearing in the neonate. The paper starts by considering the technical limitations of click ABR and explores the alternative electrophysiological methods. It then considers where ABR is required in the screening of neonates. The role of bone conduction ABR in estimating the conductive component of any hearing loss is discussed. Finally, the ability of the neonatal ABR to predict the long-term audiometric outcome of permanently hearing-impaired children is considered.     

Identification of neonatal hearing impairment: hearing status at 8 to 12 months corrected age using a visual reinforcement audiometry protocol

OBJECTIVES: 1) To describe the hearing status of the at-risk infants in the National Institutes of Health-Identification of Neonatal Hearing Impairment study sample at 8 to 12 mo corrected age (chronologic age adjusted for prematurity). 2) To describe the visual reinforcement audiometry (VRA) protocol that was used to obtain monaural behavioral data for the sample. DESIGN: All neonatal intensive care unit infants and well babies with risk factors (including well babies who failed neonatal tests) were targeted for follow-up behavioral evaluation once they had reached 8 mo corrected age. Three thousand one hundred and thirty-four (64.4%) of the 4868 surviving infants returned for at least one behavioral hearing evaluation, which employed a well-defined VRA protocol. VRA thresholds or minimum response levels (MRLs) were determined for speech and pure tones of 1.0, 2.0, and 4.0 kHz for each ear using insert earphones. RESULTS: More than 95% of the infants were reliably tested with the VRA protocol; 90% provided complete tests (four MRLs for both ears). Ninety-four percent of the at-risk infants were found to have normal hearing sensitivity (MRLs of 20 dB HL) at 1.0, 2.0, and 4.0 kHz in both ears. Of the infants, 2.2% had bilateral hearing impairment, and 3.4% had impairment in one ear only. More than 80% of the impaired ears had losses of mild-to-moderate degree. CONCLUSIONS: This may be the largest study to attempt to follow all at-risk infants with behavioral audiometric testing, regardless of screening outcome, in an effort to validate the results of auditory brain stem response, distortion product otoacoustic emission, and transient evoked otoacoustic emission testing in the newborn period. It is one of only a few studies to report hearing status of infants at 1 yr of age, using VRA on a clinical population. Successful testing of more than 95% of the infants who returned for the VRA follow-up documents the feasibility of obtaining monaural behavioral data in this population.     

Comparison of hearing screening programs between one step with transient evoked otoacoustic emissions (TEOAE) and two steps with TEOAE and automated auditory brainstem response

OBJECTIVE: To compare the efficacy between one step with transient evoked otoacoustic emissions (TEOAE) and two steps with TEOAE and automated auditory brainstem response (AABR) in a newborn hearing screening program. We investigated their differences in referral rate, the accurate identification rate of congenital hearing loss (HL), and cost effectiveness. METHOD: From November 1998 to December 2004, a total of 21,273 healthy newborns were screened for HL in Mackay Memorial Hospital, Taipei. In the periods from November 1998 to January 2004 and from February 2004 to December 2004, the screening tools used were TEOAE alone (n = 18,260) and TEOAE plus AABR (n = 3,013), respectively. RESULTS: A statistically significant decrease of referral rate was achieved in the group using TEOAE and AABR as screening tools when compared with TEOAE alone (1.8% vs. 5.8%). The accurate identification rate of congenital HL was 0.45% in TEOAE protocol and 0.3% in TEOAE and AABR protocol, which was not statistically significant. The total direct costs per screening were 10.1 U.S. dollars for the program using TEOAE alone and 8.9 U.S. dollars for the TEOAE plus AABR program. The intangible cost, however, was much higher in the earlier program because of the higher referral rate. CONCLUSION: In terms of the efficacy of a hearing screening program using the one step TEOAE and two step TEOAE and AABR programs, the later significantly decreased the referral rate from 5.8% to 1.8%. No significant difference was noted between the accurate identification rates of congenital HL. The total costs, including expenditures and intangible cost, were lower in the protocol with TEOAE plus AABR.     

DPOAE与高刺激率ABR在听力正常耳鸣患者中的应用价值

目的 观察分析听力正常的耳鸣患者畸变产物耳声发射(DPOAE)与高刺激率听性脑干反应(ABR)检测的特征,探讨其在耳鸣评估中的应用价值。 方法 选取耳鼻咽喉科门诊听力正常的青年耳鸣患者31例(46耳)为耳鸣组,另外选取听力结果正常的青年无耳鸣者25例(50耳)为正常对照组,分别进行纯音听阈测定、声导抗测听、DPOAE和高低刺激率ABR的检测,对比两组受试者DPOAE各频检出率和信噪比以及高低刺激率ABR各波潜伏期(PL)、波间期(IPL)、波幅以及两种刺激速率下的潜伏期和波间期差值(△PL和△IPL)。 结果 DPOAE各频检出率两组无显著性差异;信噪比在8 kHz,耳鸣组较对照组降低,差异有统计学意义(P<0.05);高低刺激率ABR结果中,不同刺激速率下两组Ⅰ、Ⅲ、Ⅴ波波幅差异均无统计学意义;高刺激速率下,耳鸣组Ⅰ~Ⅴ IPL较对照组延长,差异有统计学意义(P<0.05),两种刺激速率下,耳鸣组Ⅰ△PL较对照组缩短,差异有统计学意义(P<0.05),耳鸣组Ⅴ△PL、Ⅰ~Ⅴ△IPL较对照组延长,差异有统计学意义(P<0.05)。 结论 DPOAE与高刺激率ABR可作为诊断耳鸣的一种客观检查方法,其对耳鸣的早期评估有重要的应用价值;增加ABR刺激速率,可提高耳鸣检测的敏感性。     

自身免疫性听神经病动物模型的建立及听性脑干反应和畸变产物耳声发射的变化

目的建立自身免疫性听神经病动物模型，探讨其听性脑干反应（auditory brainstem response ABR）和畸变产物耳声发射（distortion product otoacoustic emission DPOAE）的变化特征。方法选取耳廓反射正常的白色豚鼠250只，分离、电泳与纯化豚鼠螺旋神经节及蜗轴内的耳蜗神经纤维抗原，然后与等量完全弗氏佐剂免疫同种豚鼠，其中正常组10只，对照组10只，试验组50只。观察ABR、DPOAE、血清IgG水平、螺旋神经节和耳蜗核团形态学的改变、听神经抗原蛋白在螺旋神经节和耳蜗神经的表达、听神经纤维超微结构的变化。结果免疫后16只动物（32／100耳）出现听性脑干反应阈提高10～25dB，Ⅰ、Ⅲ波潜伏期延长，到免疫后第3周最为明显，随后有逐渐恢复的趋势，其中Ⅲ波潜伏期到第6周恢复正常；该组豚鼠DPOAE没有变化，动物血清IgG显著性升高，与对照组相比差异有统计学意义（F=10．03，P〈0．05）；均有不同程度的螺旋神经节细胞变性、数目减少，螺旋神经节和小血管周围有淋巴细胞浸润；听神经纤维出现脱髓鞘、髓鞘断裂等现象。豚鼠耳蜗核各亚核团平均细胞密度和细胞平均面积各组差异比较没有统计学意义；听神经蛋白完全分布于耳蜗螺旋神经节和听神经纤维组织。免疫后34只动物（68／100耳）没有出现ABR反应阈升高，血清IgG没有升高，与对照组相比差异没有统计学意义，螺旋神经节、耳蜗核团、听神经纤维超微结构没有变化。结论建立了豚鼠自身免疫性听神经病动物模型，该动物模型的ABR反应阈轻中度提高，Ⅰ、Ⅲ波有自然恢复的趋势。DPOAE没有变化。     

听性脑干反应和畸变产物耳声发射在糖尿病患者听功能检测中的应用

目的:研究糖尿病(DM)患者听力损失特点,探讨其听性脑干反应(ABR)和畸变产物耳声发射(DPOAE)变化特征。方法:对在我院就诊的136例(272耳)DM患者(实验组)的一般情况、有无微血管并发症及听力损失程度等进行问卷调查,按每10岁分为30～40岁,>40～50岁,>50～60岁,>60～70岁4个年龄段,均对其进行纯音听阈(PTT)、声导抗、ABR和DPOAE检测,并与120例(240耳)同样分为4组的正常同龄成人(对照组)进行比较。结果:实验组30～40岁年龄段其ABRⅠ～Ⅴ波间期及反应阈与对照组比较差异无统计学意义,40岁以上患者ABR反应阈随增龄明显增加、波间期延长,而且60岁以上患者Ⅲ～Ⅴ、Ⅰ～Ⅴ波间期的延长与同龄对照组比较差异有统计学意义(P<0.05)。实验组与对照组患者的DPOAE检出率均为100%,但早期DM患者DPOAE幅值在1～8kHz均较同龄对照组降低,且以4kHz幅值减小明显,变化差异有统计学意义(P<0.05)。结论:DM患者多为双侧渐进性的轻、中度听力损害,ABR及其听阈异常与患者年龄、性别及有无微血管并发症相关,而与DM类型及病程无关。DPOAE可用于了解早期DM患者的耳蜗损害。     

Paediatric auditory brainstem response and pure-tone audiometry: threshold comparisons. A study of 142 difficult-to-test children

Auditory brainstem response (ABR) thresholds have been determined in 142 anaesthetized 'difficult-to-test' children. The stimuli employed were 2-kHz tone bursts. Pneumatic otomicroscopy was carried out prior to the ABR assessment in all cases, and diagnostic myringotomy was performed when there was the slightest suspicion of abnormality. Long-term follow-up pure-tone audiograms were obtained in 56 patients. A comparison was made between ABR and pure-tone thresholds in the 2-4 kHz range both in healthy middle ears and in ears having middle ear effusion (MEE) at the time of ABR measurement. A correction factor for prediction of behavioural threshold from the ABR threshold both in healthy and in MEE ears is proposed.     

Identification of neonatal hearing impairment: evaluation of transient evoked otoacoustic emission, distortion product otoacoustic emission, and auditory brain stem response test performance

OBJECTIVES: The purpose of this study was to compare the performance of transient evoked otoacoustic emissions (TEOAEs), distortion product otoacoustic emissions (DPOAEs), and auditory brain stem responses (ABRs) as tools for identification of neonatal hearing impairment. DESIGN: A total of 4911 infants including 4478 graduates of neonatal intensive care units, 353 well babies with one or more risk factors for hearing loss (Joint Committee on Infant Hearing, 1994) and 80 well babies without risk factor who did not pass one or more neonatal test were targeted as the potential subject pool on which test performance would be assessed. During the neonatal period, they were evaluated using TEOAEs in response to an 80 dB pSPL click, DPOAE responses to two stimulus conditions (L1 = L2 = 75 dB SPL and L1 = 65 dB SPL L2 = 50 dB SPL), and ABR elicited by a 30 dB nHL click. In an effort to describe test performance, these "at-risk" infants were asked to return for behavioral audiologic assessments, using visual reinforcement audiometry (VRA) at 8 to 12 mo corrected age, regardless of neonatal test results. Sixty-four percent of these subjects returned and reliable VRA data were obtained on 95.6% of these returnees. This approach is in contrast to previous studies in which, by necessity, efforts were made to follow only those infants who "failed" the neonatal screening tests. The accuracy of the neonatal measures in predicting hearing status at 8 to 12 mo corrected age was determined. Only those infants who provided reliable, monaural VRA test results were included in the analysis. Separate analyses were performed without regard to intercurrent events (i.e., events between the neonatal and VRA tests that could cause their results to disagree), and then after accounting for the possible influence of intercurrent events such as otitis media and late-onset or progressive hearing loss. RESULTS: Low refer rates were achieved for the stopping criteria used in the present study, especially when a protocol similar to the one recommended in the National Institutes of Health (1993) Consensus Conference Report was followed. These analyses, however, do not completely describe test performance because they did not compare neonatal screening test results with a gold standard test of hearing. Test performance, as measured by the area under a relative operating characteristic curve, were similar for all three neonatal tests when neonatal test results were compared with VRA data obtained at 8 to 12 mo corrected age. However, ABRs were more successful at determining auditory status at 1 kHz, compared with the otoacoustic emission (OAE) tests. Performance was more similar across all three tests when they were used to identify hearing loss at 2 and 4 kHz. No test performed perfectly. Using either the two- or three-frequency pure-tone average (PTA), with a fixed false alarm rate of 20%, hit rates for the neonatal tests, in general, exceeded 80% when hearing impairment was defined as behavioral thresholds > or =30 dB HL. All three tests performed similarly when a two-frequency (2 and 4 kHz) PTA was used as the gold standard; OAE test performance decreased when a three-frequency PTA (adding 1 kHz) was used as the gold standard definition. For both PTA and all three neonatal screening measures, however, hit rate increased as the magnitude of hearing loss increased. CONCLUSIONS: Singly, all three neonatal hearing screening tests resulted in low refer rates, especially if referrals for follow-up were made only for the cases in which stopping criteria were not met in both ears. Following a protocol similar to that recommended in the National Institutes of Health (1993) Consensus Conference report resulted in refer rates that were less than 4%. TEOAEs at 80 dB pSPL, DPOAE at L1 = 65, L2 = 50 dB SPL and ABR at 30 dB nHL measured during the neonatal period, and as implemented in the current study, performed similarly at predicting behavioral hearing status at 8 to 12