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Supplemental Digital Content is available in the text., Objectives: Early detection of neonatal hearing impairment moderates the negative effects on speech and language development. Universal neonatal hearing screening protocols vary in tests used, timing of testing and the number of stages of screening. This study estimated the cost-effectiveness of various protocols in the preparation of implementation of neonatal hearing screening in Albania. Design: A micro-simulation model was developed using input on demography, natural history of neonatal hearing impairment, screening characteristics and treatment. Parameter values were derived from a review of the literature and expert opinion. We simulated multiple protocols using otoacoustic emissions (OAE) and automated auditory brainstem response (aABR), varying the test type, timing and number of stages. Cost-effectiveness was analyzed over a life-time horizon. Results: The two best protocols for well infants were OAE followed by aABR (i.e., two-stage OAE-aABR) testing in the maternity ward and single-aABR testing. Incremental cost-effectiveness ratios were €4181 and €78,077 per quality-adjusted life-year gained, respectively. Single-aABR screening led to more cases being detected compared to a two-stage screening program. However, it also resulted in higher referral rates, which increased the total costs of diagnostics. Multi-staged screening decreased referral rates but may increase the number of missed cases due to false-negative test results and nonattendance. Conclusions: Only the 2-stage OAE-aABR (maternity ward) protocol was below the willingness-to-pay threshold of €10,413 for Albania, as suggested by the World Health Organization, and was found to be cost-effective. This study is among the few to assess neonatal hearing screening programs over a life-time horizon and the first to predict the cost-effectiveness of multiple screening scenarios.

This study aims to find out the prevalence of hearing impairment in neonates of mothers with diabetes mellitus. The objective is to assess any correlation between the glycemic control and the development of neonatal hearing impairment. A total of 120 neonates of diabetic mothers were included in the study. Data was collected from hospital medical records, direct interview of parent or care taker and clinical examination of child done whenever possible. 120 Neonates were evaluated by OAE soon after birth. Those who failed the test are evaluated with BERA and results were statistically analysed. In our study prevalence of deafness in neonates of mothers with diabetes mellitus was 4.16%. Prevalence of hearing impairment was higher in neonates of mothers with pre gestational diabetes (9.09%) than gestational diabetes mellitus (3.06%). Mean of HbA1c was higher in mothers of neonates with hearing impairment than those without hearing impairment. Prevalence of deafness in neonates of mothers with diabetes mellitus was 4.16%, which is about sevena times higher than the prevalence of deafness in neonates without any risk factors. Prevalence was higher in neonates of mothers with pre gestational diabetes than neonates of mothers with gestational diabetes mellitus.

Objective: The aim of the study was to investigate into the risk factors for failure in the first-time screening test among high-risk neonates in neonatal intensive care unit (NICU) in order to further clarify the etiology of neonatal hearing impairment, thus providing insights into early prevention and intervention. Methods: We performed automated auditory brainstem response (AABR), distortion product otoacoustic emission (DPOAE), and acoustic immittance (AI) on 2,194 high-risk neonates admitted into the NICU of Shanghai Children’s Medical Center from January 2015 to December 2019, and the risk factors, including premature birth, hyperbilirubinemia, and infant respiratory distress syndrome, were analyzed retrospectively by the univariate χ2 test and multivariate stepwise logistic regression analysis. Results: The pass rates of AABR, DPOAE, and AI were 70.21, 78.44, and 93.12%, respectively, in 2,194 cases of high-risk neonates screened, which are significantly lower than those of healthy controls. The most common diagnoses included artificial feeding, preterm birth, C-section, low birth weight (LBW), neonatal hyperbilirubinemia (NHB), neonatal respiratory distress syndrome (NRDS), congenital heart disease (CHD), gestational diabetes mellitus, pregnancy-induced hypertension syndrome, advanced maternal age (AMA), twins, and in vitro fertilization. Stepwise logistic regression analysis indicated that the AABR pass rate was negatively correlated with LBW (p = 0.002), NHB (p < 0.001), NRDS (p = 0.007), artificial or mixed feeding (p = 0.018), and CHD (p = 0.005). The pass rate of DPOAE was negatively correlated with artificial or mixed feeding (p = 0.041), NHB (p < 0.001), LBW (p = 0.007), very LBW (VLBW) (p = 0.008), and C-section (p < 0.001). The pass rate of AI was negatively correlated with revised AMA (≥40 year) (p < 0.001), NHB (p = 0.043), C-section (p = 0.005), and artificial/mixed feeding (p = 0.036). Conclusion: The hearing screening pass rates of high-risk neonates in the NICU were lower than those of normal neonates, among which the rate of AABR was significantly lower than that of DPOAE. NRDS, NHB, LBW, revised AMA, CHD, C-section, and artificial feeding are potential risk factors of hearing impairment. The combination of different hearing screening tests is necessary for accurate diagnosis of congenital hearing disorders.

Objective: To investigate the variance in reported prevalence rates of permanent neonatal hearing impairment (HI) worldwide.Design: A systematic review and meta-analysis was performed on reported p...

To study the role of Otoacoustic emission test in neonatal screening at tertiary center. The study was conducted in the ENT department of LN medical college and JK hospital Bhopal (M.P) as a territory center between 2015 and 2017 were 1250 newborns were screened with Otoacoustic emission test with portable Interacoustics OAE DK-5610 assens an routine screening investigation. In our study a multistep screening with OAE was done, 1250 newborns (659 boys and 591 girls) were assessed. In our study we have found that OAE has 66.7% sensitivity and 98.8% specificity in diagnosis of neonatal hearing impairment. Its positive and negative predictive value was 33.3% and 99.7% respectively. It is essential to examine the generalized development of newborns by identifying hearing loss at birth and providing a screening test for assessment of them. 1250 newborns were assessed we compared the results of OAE (screening test) with the results of ABR (diagnostic test) and found sensitivity of OAE to be 66.7% and its specificity 98.8%. We conclude from these results that OAE is a good screening test for hearing loss of neonates, but the results must be confirmed with BERA test.

Hearing impairment is one of the most common birth defects in children. Universal newborn hearing screenings have been performed for 19 years in Guangdong province, China. A screening/diagnosis/intervention system has gradually been put in place. Over the past 10 years, a relatively complete data management system had been established. In the present study, an etiological analysis of newborn cases that failed the initial and follow-up screenings was performed. The nature and degree of hearing impairment in newborns were confirmed by a set of procedures performed at the time of initial hearing screening, rescreening and final hearing diagnosis. Then, multiple examinations were performed to explore the associated etiology. Over a period of 10 years, 720 children were diagnosed with newborn hearing loss. Among these children, 445 (61.81%) children had a clearly identified cause, which included genetic factor(s) (30.56%), secretory otitis media (13.30%), maternal rubella virus infection during pregnancy (5.83%), inner ear malformations (4.86%), maternal human cytomegalovirus infection during pregnancy (2.92%), malformation of the middle ear ossicular chain (2.50%) and auditory neuropathy (1.81%). In addition, 275 cases of sensorineural hearing loss of unknown etiology accounted for 38.19% of the children surveyed. Long-term follow-up is needed to detect delayed hearing impairment and auditory development in children. The need for long-term follow-up should be taken into account when designing an intervention strategy. Furthermore, the use of the deafness gene chip should further elucidate the etiology of neonatal hearing impairment.

Objectives Neonatal hearing impairment is a common disorder with a prevalence of 1 to 2‰ worldwide, with significant consequences on overall development when rehabilitated too late. New-born hearing screening has been implemented in the 1990s in most European countries and the USA. The Upper-Normandy region of France has been conducting a pilot program since 1999. The aim of this prospective study was to evaluate and critically analyse it. Methods The Upper-Normandy universal new-born hearing screening program is performed in two steps. Between 1999 and 2004, first, we administered a Transient Evoked Oto Acoustic Emission (TEOAE) test was administered a few days after birth for healthy newborns without risk factors. For newborns admitted to a neonatal intensive care unit (NICU) or presenting risk factors, was administered an automated auditory brainstem response (AABR) test prior to discharge. Second, newborns who failed the initial hearing screening were retested as outpatients using TEOAE. Since 2004, infants who failed the initial screen were tested with AABR 3 to 4 weeks later as outpatients, providing an opportunity to compare the two protocols. Results Overall screening coverage in the Upper-Normandy region is 99.8%. First step coverage is 99.58% in well-infant nurseries and 97.09% in the NICU. The test–retest procedure during the first step and the use of AABR for the second resulted in higher follow-up rates and lower false positive rates. Conclusions The Upper-Normandy region universal newborn hearing screening program facilitated diagnosis and rehabilitation of infants before age of 9 months, most notably when severe to profound hearing impairment was found.

Producción Científica, Dado que el potencial discapacitante que causa la deficiencia auditiva neonatal disminuye con una detección e intervención tempranas, hemos elaborado un proyecto de investigación, con el que nos proponemos conocer el grado de desarrollo del lenguaje de los niños y niñas que procedentes del cribado auditivo universal, han sido diagnosticados/as por nosotros de hipoacusia prelingual en estos últimos 15 años y analizar las variables determinantes y las que son modificables. El objeto de esta comunicación consistirá en presentar la metodología que vamos a utilizar. Método: Partimos de los datos almacenados en nuestro Servicio de ORL, que comprende a 282 niños con hipoacusia. Hemos tenido la oportunidad de crear un grupo de investigación en el que coincidimos especialistas de la audición infantil y del lenguaje, por lo que contamos con medios suficientes para el estudio. Resultados: Describimos los elementos que configuran este proyecto, en relación al equipo de trabajo y a su desarrollo. Tras aplicar unos criterios de exclusión/inclusión, hemos seleccionado a un grupo de 45 niños entre 3 y 15 años, definiendo sus características auditivas. Mediante pruebas específicas, adaptadas a la edad, estudiaremos los diferentes aspectos del lenguaje; y a través Rev. ORL, 20xx, x x de una entrevista estructurada realizada a los padres, intentaremos determinar las variables que influyen en el proceso re-habilitador. Finalmente, los datos serán analizados estadísticamente. Discusión: La variabilidad y la escasa prevalencia de la hipoacusia infantil, dificultan la realización de estudios con población suficiente para obtener resultados estadísticamente significativos. Sin embargo, creemos que el grupo de niños seleccionado y la metodología utilizada nos permitirán conocer mejor las variables influyentes en el desarrollo del lenguaje. Conclusiones: El programa de cribado auditivo universal ha permitido una intervención más precoz, lo que debería mejorar los niveles de lenguaje de los niños detectados/as con hipoacusia. Aunque el desarrollo normalizado de la comunicación depende de otros factores difíciles de determinar, a través del protocolo presentado pretendemos equiparar estos resultados, validando el proceso de cribado/diagnóstico e intervención de nuestro medio., Universidad de Valladolid

Background: Serious hearing problems appear in approximately one in 1000 newborns. In 2000, the Joint Committee on Infant Hearing defined a list of risk factors for neonatal hearing impairment relating to health, physical characteristics and family history. The aim of this study is to determine which personal, environmental and social factors are associated with the prevalence of congenital hearing impairment (CHI). Methods: The entire population of 103 835 term newborns in Flanders, Belgium, was tested by a universal neonatal hearing screening (UNHS) programme using automated auditory brainstem responses (AABR). In the case of a positive result, a CHI diagnosis was verified in specialized referral centres. Socio-demographic risk factors were investigated across the entire population to study any relationship with CHI. Results: The prevalence of bilateral CHI of 35 dB nHL (normal hearing level) or more was 0.87/1000 newborns. The sensitivity and specificity of the screening test were 94.02 and 99.96%, respectively. The socio-demographic factors of gender, birth order, birth length, feeding type, level of education and origin of the mother were found to be independent predictors of CHI. Conclusions: The socio-demographic factors found to be associated with CHI extend the list of classic risk factors as defined by the American Academy of Pediatrics (AAP). Assessment of these additional factors may alert the treating physician to the increased risk of newborn hearing impairment and urge the need for accurate follow-up. Moreover, this extended assessment may improve decision making in medical practice and screening policy.

Objective To investigate the feasibility of neonatal hearing impairment in newborn babies in Abidjan, Cote d’Ivoire. Methods It is a cross-sectional study in which all infants aged from 3 to 28 days, attending for Bacille Calmette–Guerin (BCG) immunization in primary care centers or hospitalized in neonatal intensive care units (NICU), between July 2007 and March 2008, were included. Screening followed a two-stage strategy with transient evoked otoacoustic emissions (TEOAE). Infants referred after the second-stage screening were scheduled for diagnostic evaluation by diagnostic auditory brainstem response (ABR). The variables analyzed were: screening coverage, referral rates; return rates for second-stage screening and diagnostic evaluation, incidence of permanent hearing loss and age at diagnosis. Results 1306 newborns, of a total of 1495, were successfully screened, giving a screening coverage of 87.4%. The average age was 4.5 days (S.D.: 2.7), with 5.85 days (S.D.: 3.17) for the immunization group and 3.20 days (S.D.: 0.40) for the neonatal unit group. In total, 286 out of the 1306 infants (21.9%) were referred after the first-stage screening; out of which 193 (67.5%) return for the second stage. After the second-stage screening, 48 (16.8%) were scheduled for diagnostic evaluation (45 from NICU and 3 from primary care centers). The overall referral rate for diagnostic evaluation was 3.7% (48/1306). Only 18.75% of those referred (9/48) returned for evaluation, and seven of them (77.8%) were confirmed with hearing loss (2 from immunization group and 5 from neonatal unit group). The prevalence of permanent hearing loss in this screened population was 5.96 per 1000 (7/1174 babies who completed the screening) [95% I.C.: 5.62–6.30 per 1000]. The mean age at diagnosis was 22 weeks (S.D.: 8.3). The reasons for non-completed screening were, according to 62 mothers: no financial means, absence of hearing loss, fear of spouse reactions, lack of information about this test and deafness. Conclusion The incidence of permanent and early hearing impairment identified by this screening program was about 6 per 1000. Routine hearing screening of infants for the early detection of hearing loss is necessary in Cote d’Ivoire. It is possible to implement such a hearing screening, targeting all newborns, in primary health care centers and neonatal intensive care units.

INTRODUCTION: Hearing loss has severe emotional, psychological, and social consequences. The early identification of hearing impairment is crucial. OBJECTIVE: To evaluate and quantify the knowledge of neonatologists, pediatricians, and residents in pediatrics regarding detection, risk factors, early diagnosis, and referral for rehabilitation of patients with neonatal hearing loss in Jundiaí, state of São Paulo, Brazil. METHODS: This was a cross-sectional contemporary cohort study including 47 physicians from three hospitals, including a questionnaire with 15 items. RESULTS: Most respondents (83%) had received information about hearing loss in their medical courses, but most had no knowledge of techniques for hearing evaluation, and degrees and types of loss. All physicians agreed that in the first six months of life, it is possible to evaluate hearing function and that it is the physician's responsibility to assess the newborn. Regarding the age that the child can receive auditory rehabilitation, the end of the first year and the second year of life predominate. CONCLUSION: Most respondents know the risk factors for the detection of neonatal hearing impairment, know how to perform procedures, and recognize the importance of diagnosis of hearing loss and the need to refer suspected cases, but most do not know the techniques used to assess hearing in newborns. INTRODUÇÃO: A deficiência auditiva acarreta graves consequências emocionais, psicológicas e sociais, sendo imprescindível a identificação precoce de alterações auditivas. OBJETIVO: Avaliar e quantificar o conhecimento de médicos neonatologistas, pediatras e residentes em Pediatria, sobre detecção, fatores de risco, diagnóstico precoce e encaminhamento para reabilitação dos pacientes acometidos por deficiência auditiva neonatal no município de Jundiaí, SP. MÉTODO: Estudo de coorte contemporânea com corte transversal, incluindo 47 médicos de três instituições hospitalares, com aplicação de um questionário de 15 perguntas. RESULTADOS: Grande parte dos entrevistados (83%) teve informações sobre deficiência auditiva em seus cursos médicos, em sua maioria desconheciam técnicas de avaliação auditiva na infância, graus e tipos de perda. Todos relataram que nos primeiros seis meses de vida já é possível avaliar a audição, sendo dever do médico se preocupar com sua comunicação. Com relação à idade em que a criança pode receber a reabilitação auditiva, predominaram o final do primeiro e o segundo ano de vida. CONCLUSÃO: A maioria dos entrevistados conhece os fatores de risco para a detecção neonatal da deficiência auditiva, realiza procedimentos, reconhece a importância do diagnóstico da deficiência auditiva e a necessidade de efetuar encaminhamento dos casos suspeitos, porém desconhece técnicas de avaliação da audição em neonatos.

This article describes the audiologic findings and medical status of infants who were found to have hearing loss, detected as part of the Identification of Neonatal Hearing Impairment (INHI) project. In addition, the neonatal and maternal health variables for the group of infants who could not be tested with visual reinforcement audiometry (VRA) due to developmental and visual disability are presented.The overall goal of the INHI project was to evaluate the test performance of auditory brain stem response and evoked otoacoustic emission (OAE) tests given in the newborn period. These tools were evaluated on the basis of the infants' hearing when tested behaviorally with VRA at 8 to 12 mo corrected age. The neonatal test results, VRA results, medical history information and a record of intercurrent events occurring between the neonatal period and the time of VRA were collated and reviewed. The purpose of this article is to review the characteristics of those infants who were found to have hearing loss.Of 2995 infants who had VRA tests judged to be of good or fair reliability, 168 had a finding of hearing loss for at least one ear, an incidence of 5.6%. Sixty-six infants had bilateral losses, an incidence of 2%, and 22 infants had bilateral hearing losses in the moderate to profound range, an incidence 0.7%. The prevalence of middle ear problems was greater than 50% among these infants with hearing loss. From the larger group of 168 infants with hearing loss, a group of 56 infants (86 ears) was chosen as those with a low probability that the hearing loss was due to transient middle ear pathology and was more likely hearing loss of a permanent nature. These were the infants used for the analyses of neonatal test performance (Norton et al., 2000). In this selected group there were 30 infants with bilateral impairment of at least mild degree, which is an incidence of 1%. There were approximately equal numbers of ears in the mild, moderate, severe and profound range of hearing loss. Risk factors associated with hearing loss were reviewed for the total sample of infants tested with VRA and for those infants with hearing loss. A history of treatment with aminoglycosides was the risk factor most often reported in the entire sample; however, there was no difference in prevalence of this risk factor for the normal-hearing and hearing-impaired groups. The risk factor associated with the highest incidence of hearing loss was stigmata of syndromes associated with sensorineural hearing loss and other neurosensory disorders. Sixty-seven infants who returned for follow-up could not be tested with VRA due to severe developmental delay or visual disability. Many of these infants had medical histories indicating the sequelae of extreme prematurity and/or very low birthweight.Most of the hearing losses found in this study were mild and, based on clinical history and tympanometry tests, many of the mild and some of the moderate impairments may have been acquired in early infancy due to middle ear effusion. In the group of infants used for determination of neonatal test performance there were approximately equal numbers of mild, moderate, severe and profound losses. Only a small percentage of infants with a conventional risk indicator for hearing loss actually had a hearing loss, and there were a significant number of infants with hearing loss who did not have a risk indicator. These findings support the need for an early identification program based on universal neonatal hearing screening rather than by targeted testing of those with risk indicators.

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.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.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 thresholdsor =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.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

The objective of this study was to describe the demographic data, medical status, and incidence of risk factors for hearing impairment in the neonatal intensive care unit (NICU) and well-baby populations in a multicenter prospective study designed to assess neonatal hearing impairment and to evaluate factors that might affect neonatal hearing test performance.This was a prospective multicenter study funded by the National Institutes of Health-National Institute on Deafness and Other Communication Disorders to evaluate the effectiveness of auditory brain stem response, transient evoked otoacoustic emissions, and distortion product otoacoustic emissions for newborn hearing screening. Research staff at each site obtained informed consent and detailed demographic and medical data, including information on established risk factors for hearing loss on 4478 high-risk infants cared for in the NICU, 2348 infants from the well-baby nurseries with no risk factor, and 353 infants from the well-baby nurseries with risk factors. For follow-up purposes the sample was divided further to include a subgroup called selects. Selects were either infants from the well-baby nursery who had an established risk factor for hearing impairment (N = 353) or did not pass the neonatal hearing screen protocol (N = 80). In this study, we focus on the distribution of infants by nursery and risk factors only. Particular effort was made to enroll infants with risk factors for hearing loss in both the NICU and well-baby nurseries. Descriptive analyses are used to describe characteristics of this sample.All 10 of the risk factors established by the Joint Committee on Infant Hearing in 1994 were identified in the NICU population. The four most common were ototoxic medications (44.4%), very low birth weight (17.8%), assisted ventilation5 days (16.4%), and low Apgar scores at 1 or 5 min (13.9%). In contrast, only six risk factors were present in the well-baby nurseries: family history (6.6%), craniofacial abnormalities (3.4%), low Apgar scores (2.8%), syndromes (0.5%), ototoxic medications (0.2%), and congenital infection (0.1%).These descriptive risk factor data reflect both the newborn populations at the study sites and the bias for enrolling infants at risk for hearing loss. The high-risk NICU sample reflects the characteristics typically found in graduates of the NICU. The data summarized in this study will be used to assess the relationships between risk factor and hearing test outcome.

Objectives 1) To describe transient evoked otoacoustic emission (TEOAE) levels, noise levels and signal to noise ratios (SNRs) for a range of frequency bands in three groups of neonates who were tested as a part of the Identification of Neonatal Hearing Impairment multi-center consortium project. 2) To describe the relations between these TEOAE measurements and age, test environment, baby state, and test time. Design TEOAEs were measured in 4478 graduates of neonatal intensive care units (NICUs), 353 well babies with at least one risk indicator, and 2348 well babies without risk factors. TEOAE and noise levels were measured for frequency bands centered at 1.0, 1.5, 2.0, 3.0, and 4.0 kHz for a click stimulus level of 80 dB SPL. For those ears not meeting “passing” stopping criteria at 80 dB pSPL, a level of 86 dB pSPL was included. Measurement-based stopping rules were used such that a test did not terminate unless the response revealed a criterion SNR in four out of five frequency bands or no response occurred after a preset number of averages. Baby state, test environment, and other test factors were captured at the time of test. Results: TEOAE levels, noise levels and SNRs were similar for NICU graduates, well babies with risk factors and well babies without risk factors. There were no consistent differences in response quality as a function of test environment, i.e., private room, unit, open crib, nonworking isolette, or working isolette. Noise level varied little across risk group, test environment, or infant state other than crying, suggesting that the primary source of noise in TEOAE measurements is infant noise. The most significant effect on response quality was center frequency. Responses were difficult to measure in the half-octave band centered at 1.0 kHz, compared with higher frequencies. Reliable responses were measured routinely at frequencies of 1.5 kHz and higher. Conclusions TEOAEs are easily measured in both NICU graduates and well babies with and without risk factors for hearing loss in a wide variety of test environments. Given the difficulties encountered in making reliable measurements for a frequency band centered at 1.0 kHz, its inclusion in a screening program may not be justified.

Objective: The purpose of this study is to describe the recruitment and retention strategies as well as the sample demographics for families with infants completing the neonatal examination and returning for follow-up. These data are compared to those infants inactivated from the study. Design: This study was a prospective, randomized clinical study. All infants who were confined to the neonatal intensive care unit (NICU) and well babies with at least one risk indicator were targeted for behavioral audiometric follow-up testing. In addition, infants without risk factors from the well-baby nursery, but who failed a newborn test, were also followed. Several variables were evaluated to determine those factors, if any, that might predict which families returned for follow-up testing. Results: Recruitment was achieved as per study design with 4911 high-risk infants and 2348 well-baby nursery infants (without risk indicators for hearing) enrolled. Of the 4911 high-risk infants enrolled, 64% were successfully recruited into the follow-up portion of the study. This was less than the projected rate of 80%. Factors predicting non-compliance with the study protocol for follow-up were predominantly sociodemographic and included nonwhite race, no insurance, substance abuse, young maternal age, more than two children at home, and late onset of prenatal care. Conclusions: Factors related to low socioeconomic status and increased social risk were the strongest predictors of poor study protocol compliance. Despite retention challenges, 64% of the targeted, high-risk infants subsequently returned for the 8-to 12-months behavioral hearing assessment protocols for validation purposes.

Objectives 1) To describe the auditory brain stem response (ABR) measurement system and optimized methods used for study of newborn hearing screening. 2) To determine how recording and infant factors related to the screening, using well-defined, specific ABR outcome measures. Design Seven thousand one hundred seventy-nine infants, 4478 from the neonatal intensive care unit (NICU) and the remaining from the well-baby nursery, were evaluated with an automated ABR protocol in each ear. Two channel recordings were obtained (vertex to mastoid or channel A and vertex to nape of neck or channel B) in response to click stimuli of 30 and 69 dB nHL in all infants as well as 50 dB nHL in infants who did not meet criteria for response at 30 dB. Criteria for response included F(SP) > or =3.1 and a tester-judgment of response. Criteria could be met in the first or repeat test with a maximum of 6144 accepted sweeps per test. Results More than 99% of infants could complete the ABR protocol. More than 90% of NICU and well-baby nursery infants "passed" given the strict criteria for response, whereas 86% of those with high risk factors met criterion for ABR response detection. The number of infants who did not meet ABR response criteria in one or both ears was systematically related to stimulus level with the largest group not meeting criteria at 30 dB followed by 50 and 69 dB nHL. Meeting criteria on the ABR was positively correlated with the amplitude of wave V, with low noise and low electrode impedance. Factors that predicted how many sweeps would be needed to reach criterion F(SP) included noise level of the test site, state of the baby (for example, quiet sleep versus crying), recording noise, electrode impedance and response latency. Channel A (vertex to mastoid) reached criterion more often than channel B (vertex to nape of neck) due to higher noise in channel B. Average total test time for 30 dB nHL screening in both ears was under 8 minutes. Well babies with risk factors took slightly longer to evaluate than other groups with this automated ABR procedure and have higher noise levels. Conclusions ABR implemented with an automated detection algorithm using a 30 dB nHL click stimulus is reliable technique for rapid assessment of auditory status in newborns. Factors other than hearing loss that influenced the test result include infant state, electrode location and impedance, testing site, and infant risk status. Even so, ABRs were reliably recorded in the vast majority of babies under circumstances in which most babies are found in the perinatal period.

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.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.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.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.

Objectives: 1) To describe distortion product otoacoustic emission (DPOAE) levels, noise levels and signal to noise ratios (SNRs) for a wide range of frequencies and two stimulus levels in neonates and infants. 2) To describe the relations between these DPOAE measurements and age, test environment, baby state, and test time. Design: DPOAEs were measured in 2348 well babies without risk indicators, 353 well babies with at least one risk indicator, and 4478 graduates of neonatal intensive care units (NICUs). DPOAE and noise levels were measured at f 2 frequencies of 1.0, 1.5, 2.0, 3.0, and 4.0 kHz, and for primary levels (L 1 /L 2 ) of 65/50 dB SPL and 75/75 dB SPL. Measurement-based stopping rules were used such that a test did not terminate unless the response was at least 3 dB above the mean noise floor + 2 SDs (SNR) for at least four of five test frequencies. The test would terminate, however, if these criteria were not met after 360 sec. Baby state, test environment, and other test factors were captured at the time of each test. Results: DPOAE levels, noise levels and SNRs were similar for well babies without risk indicators, well babies with risk indicators, and NICU graduates. There was a tendency for larger responses at f 2 frequencies of 1.5 and 2.0 Hz, compared with 3.0 and 4.0 kHz; however, the noise levels systematically decreased as frequency increased, resulting in the most favorable SNRs at 3.0 and 4.0 kHz. Response levels were least and noise levels highest for an f 2 frequency of 1.0 kHz. In addition, test time to achieve automatic stopping criteria was greatest for 1.0 kHz. With the exception of active/alert and crying babies, baby state had little influence on DPOAE measurements. Additionally, test environment had little impact on these measurements, at least for the environments in which babies were tested in this study. However, the lowest SNRs were observed for infants who were tested in functioning isolettes. Finally, there were some subtle age affects on DPOAE levels, with the infants born most prematurely producing the smallest responses, regardless of age at the time of test. Conclusions: DPOAE measurements in neonates and infants result in robust responses in the vast majority of ears for f 2 frequencies of at least 2.0, 3.0 and 4.0 kHz. SNRs decrease as frequency decreases, making the measurements less reliable at 1.0 kHz. When considered along with test time, there may be little justification for including an f 2 frequency at 1.0 kHz in newborn screening programs. It would appear that DPOAEs result in reliable measurements when tests are conducted in the environments in which babies typically are found. Finally, these data suggest that babies can be tested in those states of arousal that are most commonly encountered in the perinatal period.

Objectives This article describes the design of a multicenter study sponsored by the National Institutes of Health. The purpose of this study was to determine the accuracy of three measures of peripheral auditory system status (transient evoked otoacoustic emissions, distortion product otoacoustic emissions, and auditory brain stem responses) applied in the perinatal period for predicting behavioral hearing status at 8 to 12 mo corrected age. The influences of the infant’s medical status, the test environment, and test and response parameters on test performance were e-amined. Design Seven institutions participated in this study. There were 7179 infants evaluated in the perinatal period. All graduates of the neonatal intensive care unit (4478) and well babies with one or more risk factor for hearing loss (353) were targeted for follow-up testing using visual reinforcement audiometry (VRA) at 8 to 12 mo corrected age. Well babies without any risk indicators (N = 2348) were not targeted for follow-up VRA testing. However, 80 of these well babies did not pass the screening protocol and thus were targeted for follow-up VRA testing as well. Perinatal test performance was evaluated using the VRA data as the “gold standard.” Results The results of this study are described in a series of 11 articles following this introductory article. Conclusions The evaluation of newborn hearing tests required a longitudinal study in which newborn test results were compared with a gold standard based on behavioral audiometric assessment. Such an evaluation was possible because all newborns, passes as well as refers, were followed up long enough to permit reliable behavioral measurements. In addition, prenatal, perinatal, and maternal history information, test environment, and test parameter information were collected to provide data that led to a complete description of factors affecting test outcomes. All of these data were obtained in a sample of sufficient ethnic, medical, and geographic diversity in efforts to increase the generalizability of the results. Finally, the data were combined in a relational data base to e-amine the factors that influence test performance. Specific information related to these issues is presented in the articles that follow.

KEYWORDS Sensorineural; hearing loss; Otitis media; congenital ABSTRACT Hearing impairment is the most prevalent sensory disability and is caused by a variety of genetic and environmental factors. Many studies have proposed otitis media, head injury, convulsions, respiratory problems and infections to the infants as the important antecedents of neonatal deafness or hearing impairment. A prospective etiological study of adverse postnatal conditions leading to bilateral sensorineural neonatal hearing impairment was conducted. In this study 1076 children below 14 years of age with congenital hearing loss were investigated. The results showed adverse postnatal history in 20.26% (218) of the cases out of 1076. High risk factors included otitis media, head injury and convulsions and respiratory distress. Majority (126/11.71%) of the cases showed otitis media followed by head injury in 4.83% (52) of the cases, convulsions in 2.78% (30) of the cases and respiratory problems in 0.92% (10) of the cases. It can be concluded that careful monitoring of the child during the first few years and vaccination against all the infections is necessary.

Background: Hearing loss in early life can have deleterious effects on child’s psychosocial, scholastic and social-emotional development. Early identification and timely intervention can provide the child with better speech and language development. This study has been done to estimate the prevalence of hearing impairment among high risk infants as per Joint Committee on Infant Hearing (JCIH) criteria and to study the risk factors associated with neonatal hearing impairment. Methods: This multicentric observational study was conducted among 613 high risk infants admitted and discharged from neonatal intensive care units (NICU) of Academy of Medical Sciences, Kannur, Kerala and Sri Siddhartha Medical College and Research Centre, Tumakuru, Karnataka, India (level III neonatology units with an NICU admissions of average around 1200 per year), during the period August 2015 - August 2016 (12 months). The babies were selected based on the JCIH 2007 criteria. All babies were subjected to behavioral audiometry (BA) and Oto Acoustic Emissions (OAE), preferably within 3 weeks. Those failing OAE were reevaluated at 6th week and with Auditory brain stem response (ABR) within 3 months time. Results: A total of 613 high risk babies were screened. 42 (6.76%) among them were having hearing impairment. The most common risk factors associated with hearing impairment was NICU stay for more than 24 hours, prematurity, low birth weight and meningitis/sepsis etc. Conclusions: Hearing impairment among high risk babies is not a rare condition. In our study, the prevalence was 6.76%. Low birth weight, admission to NICU for more than 24 hours, low APGAR, meningitis/sepsis, maternal and neonatal complications are significant risk factors for hearing impairment among neonates. This highlights the need for neonatal screening. Though we recommend a universal screening program, at least a targeted approach should be practiced in neonatal care. Those babies who are found to have hearing impairment should be closely followed up with early intervention and rehabilitation.

Congenital hearing loss is a major health care problem that tends to retard the developmental milestones of children. It takes early detection and intervention to avoid a permanent loss in acquisition of speech and cognitive functions. Hence, the importance of hearing screening in all newborns especially in the developing world for accurate statistics and early intervention. Therefore, this work was aimed at detecting the crude prevalence of congenital hearing loss among the newborns in Benin City.Consecutive neonates at designated immunization centers in Benin City metropolis were screened for hearing loss via the detection and analysis of distortion product otoacoustic emissions from both ears. The handheld otoacoustic machine model MAICO 8172 was employed and the outcome results presented in tables. Statistical analysis was performed using SPSS 11.A total of 400 neonates (218 males and 182 females) were screened for the presence of otoacoustic emission in both ears. Ninety neonates (22.5%) p0.05 were referred. Bilateral hearing loss was seen in 26 (6.5%) whereas 64 (16%) had unilateral loss.The screening tests suggest a high crude prevalence (6.5%) of bilateral neonatal hearing impairment in Benin City necessitating confirmation and intervention. The study fortifies the need for hearing screening among all new born in developing countries.

Objective The purposes of this article are to describe the overall protocol for the Identification of Neonatal Hearing Impairment (INHI) project and to describe the management of the data collected as part of this project. A well-defined protocol and database management techniques were needed to ensure that data were 1) collected accurately and in the same way across sites; 2) maintained in a database that could be used to provide feedback to individual sites regarding enrollment and the extent to which the protocol was complete on individual subjects; and 3) available to answer project questions. This article describes techniques that were used to meet these needs. Design This study was a prospective, randomized study that was designed to evaluate auditory brain stem responses, transient evoked otoacoustic emissions, and distortion product otoacoustic emissions as hearing-screening tools, and to relate neonatal test findings to hearing status, defined by visual reinforcement audiometry at 8 to 12 mo of age. Measures of middle-ear function also were obtained at some sites as part of the neonatal test battery. In addition, other clinical and demographic data were gathered to determine the extent to which factors, other than auditory status, influenced test behavior. Three groups were evaluated: neonatal intensive care unit (NICU) infants (those who spent 3 or more days in a NICU), well babies with risk factors for hearing loss, and well babies without risk factors. Six centers participated in the trial. The testers for the project included audiologists, technicians, audiology graduate students, and medical research staff. The same computerized neonatal test program was applied at each center. This program generated the neonatal test database automatically. Clinical and demographic data were collected by means of concise data collection forms and were entered into a database at each site. After the neonatal test, subjects from the NICU and at-risk well babies were evaluated with visual reinforcement audiometry starting at 8 to 12 mo of age. All data were electronically transmitted to the core site where they were merged into one overall database. This database was exercised to provide feedback and to identify discrepancies throughout the course of the study. In its final form, it served as the database on which all analyses were performed. Results and conclusion The protocol was a departure from typical hearing screening procedures in terms of 1) its regimented application of three screening measures; 2) the detailed information that was obtained regarding subject clinical and demographic factors; and 3) its application of the same procedures across six centers having diverse geographic location and subject demographics. A learning curve for successfully executing the study protocols was observed. Throughout the study, monthly reports were generated to monitor subject enrollment, check for data completeness, and to perform data integrity checks. In combination with monthly data reports and checks that occurred throughout the progression of the study, miscellaneous data audits were performed to check accuracy of neonatal testing programs and to cross-check information entered in the clinical and demographic database. The data management techniques used in this project helped to ensure the quality of the data collection process and also allowed for detailed analyses once data were collected. This was particularly important because it enabled us to evaluate not only the performance of individual measures as screening tools, but also permitted an evaluation of the influence of other variables on screening test results.

This article summarizes the results of a multi-center study, "Identification of Neonatal Hearing Impairment," sponsored by the National Institutes of Health. The purpose of this study was to determine the performance characteristics of three measures of peripheral auditory system status, transient evoked otoacoustic emissions (TEOAEs), distortion product otoacoustic emissions (DPOAEs), and auditory brain stem responses (ABR), applied in the neonatal period in predicting hearing status at 8 to 12 mo corrected age.The design and implementation of this study are described in the first two articles in this series. Seven institutions participated in this study; 7179 infants were evaluated. Graduates of the neonatal intensive care unit and well babies with one or more risk factors for hearing loss were targeted for follow-up testing using visual reinforcement audiometry (VRA) at 8 to 12 mo corrected age. Neonatal test performance was evaluated using the VRA data as the "gold standard."The major results of the study are described in the nine articles preceding this summary article. TEOAEs in response to an 80 dB pSPL click, DPOAEs in response to L1 = 65 and L2 = 50 dB SPL and ABR in response to a 30 dB nHL click performed well as predictors of permanent hearing loss of 30 dB or greater at 8 to 12 mo corrected age. All measures were robust with respect to infant state, test environment and infant medical status. No test performed perfectly.Based on the data from this study, the 1993 National Institutes of Health Consensus Conference-recommended protocol-an OAE test followed by an ABR test for those infants failing the OAE test-would result in low referral rate (96 to 98%). TEOAEs for 80 dB pSPL, ABR for 30 dB nHL and DPOAEs for L1 = 65 dB SPL and L2 = 50 dB SPL perform well in predicting hearing status based on the area under the relative operating characteristic curve. Accuracy for the OAE measurements are best when the speech awareness threshold or the pure-tone average for 2.0 kHz and 4 kHz are used as the gold standard. ABR accuracy varies little as a function of the frequencies included in the gold standard. In addition, 96% of those infants returning for VRA at 8 to 12 mo corrected age were able to provide reliable ear-specific behavioral thresholds using insert earphones and a rigorous psychophysical VRA protocol.

The American Hearing Research Foundation has developed a regional Infant Screening Program in the state of Illinois, designed to meet the vital need for early identification of hearing impairment on a mass scale. The four major components of the program include: 1. Application of the High Risk Register to the general newborn population, 2. Hearing Screening in the Intensive Care Nursery, 3. Electrophysiologic confirmation with Brain Stem Electric Response testing and 4. Subsequent and immediate remediation and/or habilitation. Brain Stem Electric Response Audiometry (BERA) has been shown to be an accurate and sensitive clinical tool for obtaining auditory thresholds in infants from birth. At the Donald T. Forsythe Otologic Laboratory in Mercy Hospital, Chicago, IL, over 250 infants and young children have been tested in a controlled study with BERA to establish or rule-out the diagnosis of hearing impairment. The use of BERA preceded by screening of a refined neonatal population has proven to be an effective method of early identification. The goals of the program are: 1. To identify hearing impaired children prior to passage of the critical periods, 2. To medically or surgically classify and treat and/or auditorily habilitate, and 3. To ultimately improve the quality of life of the child born with hearing impairment.