Newborn Hearing Screening to Diagnosis: A Clinical Study of 15,818 Cases

Newborn Hearing Screening to Diagnosis: A Clinical Study of 15,818 Cases | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Newborn Hearing Screening to Diagnosis: A Clinical Study of 15,818 Cases Yanmin Chen, Feiwei An This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8110222/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Dec, 2025 Read the published version in International Journal of Pediatric Otorhinolaryngology → Version 1 posted You are reading this latest preprint version Abstract Objective: To analyze the epidemiological characteristics, risk factors, and follow-up outcomes of neonatal hearing loss, thereby providing a basis for optimizing screening and intervention strategies. Methods: A total of 15,818 newborns born at Shenzhen Maternity and Child Healthcare Hospital between January and December 2022 were enrolled. Initial screening was conducted using distortion product otoacoustic emissions (DPOAE). Infants who referred underwent rescreening with a combination of DPOAE and automated auditory brainstem response(AABR), and those who failed were referred for comprehensive diagnostic evaluation at 3 months of age, including auditory brainstem response(ABR), auditory steady-state response(ASSR), and acoustic immittance testing. Pass rates and loss-to-follow-up rates at each stage were analyzed, along with the characteristics and risk factors of confirmed hearing loss. Results: Of the cohort, 15,643 newborns completed the initial screening, with a pass rate of 96.71%. Forty-six cases were confirmed with hearing loss, yielding a detection rate of 2.94 per 1,000. The pass rate for the right ear (97.93%) was significantly higher than for the left ear (97.55%) (P < 0.001). Among the diagnosed cases, hearing loss was predominantly unilateral (56.52%), mild-to-moderate in degree (73.91%), and conductive in type (50.00%). The primary risk factors identified were preterm birth (30.43%), low birth weight (17.39%), craniofacial anomalies (15.22%), and hyperbilirubinemia (13.04%). Follow-up and genetic testing were completed for 42 infants. Pathogenic variants in GJB2 or SLC26A4 genes were identified in 4 cases (9.52%). Hearing returned to normal in 10 infants (23.81%), while the hearing status of those with severe-to-profound loss remained stable. A significant difference was observed in the distribution of hearing loss between the initial diagnosis and follow-up (P < 0.05). Conclusion: This study found a neonatal hearing loss detection rate consistent with previous reports, observed a higher screening pass rate in the right ear. The hearing loss was predominantly unilateral and mild-to-moderate, with follow-up revealing a dichotomous trend of either spontaneous recovery or persistence. This pattern highlights the necessity of enhancing follow-up management during the critical window between rescreening and diagnosis, and of formulating stratified and individualized intervention and follow-up protocols. Newborn Hearing Screening Hearing Loss Risk Factors Detection Rate Follow-Up Studies Intervention Strategies Figures Figure 1 Figure 2 1. Introduction Congenital hearing loss (CHL) ranks among the most common birth defects and represents the most frequently diagnosed condition through newborn disease screening programs [ 1 – 2 ]. The reported global incidence of neonatal hearing loss ranges between 1 and 3 per 1,000 live births [ 3 – 5 ]. Normal auditory function is a fundamental prerequisite for language acquisition, with typically hearing infants entering a critical period for language development between 4 and 9 months of age, which should not extend beyond 11 months. Robust clinical evidence has confirmed that early identification and diagnosis of hearing loss before 6 months of age, followed by prompt and scientifically guided intervention, can significantly mitigate its long-term adverse effects on speech [ 6 – 7 ], cognitive, social, and psychological-behavioral development, thereby substantially improving long-term outcomes [ 8 ]. The implementation of universal newborn hearing screening (UNHS) has laid the groundwork for the early detection, diagnosis, and intervention of CHL. Since China issued the "Guidelines for Early Hearing Assessment and Intervention in Newborns and Infants" in 2009, the national screening system has been progressively refined [ 9 ]. However, the overall effectiveness of UNHS depends not only on high initial screening coverage but also critically on the seamless linkage between subsequent stages—diagnosis, intervention, and long-term follow-up. In practice, significant challenges remain, including the loss to follow-up between the initial screening and confirmatory diagnosis, as well as regional variations in the audiological characteristics and etiological profiles of hearing loss. Shenzhen, a modern metropolis characterized by a large migrant population and a high annual number of births, provides a regionally representative context for investigating the epidemiological profile of CHL. Therefore, this study analyzed hearing screening and follow-up data from 15,818 newborns delivered at Shenzhen Maternity and Child Healthcare Hospital between January and December 2022. The aims were to determine the local detection rate, delineate the clinical and audiological characteristics, and identify the associated risk factors of neonatal hearing loss in this population. The findings are expected to provide localized evidence for optimizing screening management protocols and enhancing intervention efficacy. 2. Materials and Methods 2.1 Study Participants This retrospective study included 15,818 live-born neonates delivered at Shenzhen Maternity and Child Healthcare Hospital between January and December 2022. From this cohort, 15,643 newborns who completed the initial hearing screening were included in the final analysis. The study population comprised 8,760 males and 6,883 females. Prior to any screening procedures, written informed consent was obtained from all participants' parents or guardians. The study protocol was approved by the Shenzhen Maternity and Child Healthcare Hospital Ethics Committee. 2.2 Hearing Screening Protocol Initial hearing screening was performed using distortion product otoacoustic emissions (DPOAE) after 48 hours of birth but before hospital discharge, in an environment with ambient noise levels below 45 dB. Screening was conducted using a Danish International Hearing Otoacoustic Emissions analyzer. The stimulus intensities were set at L1 = 45 dB SPL and L2 = 55 dB SPL, with a frequency ratio f2/f1 = 1.22. The test covered six frequency points (0.5, 1, 2, 3, 4, and 6 kHz). A "PASS" result was defined as responses present in at least four of the six frequencies; otherwise, the result was recorded as "REFER." Infants who failed the initial screening were scheduled for rescreening around 42 days after birth using a combination of DPOAE and automated auditory brainstem response (AABR). 2.3 Audiological Diagnostic Procedures Infants who did not pass the rescreening were referred for a comprehensive audiological diagnostic assessment at a corrected age of 3 months. Prior to testing, all subjects underwent routine otoscopic examination by an otolaryngologist to inspect the ear canal and remove any cerumen if present. To ensure accurate results, natural sleep was induced by oral administration of 10% chloral hydrate solution (50 mg/kg) before testing commenced in a standard sound-attenuated booth. The diagnostic test battery included: Auditory brainstem response (ABR): Testing was performed using the Danish International Hearing Eclipse evoked potential system with insert earphones. Stimulus parameters included alternating polarity clicks presented at a rate of 17.7 times per second, with 1000 sweeps averaged and a bandpass filter of 100–3000 Hz. Electrode montage placed the recording electrode at the hairline, the ground electrode at the glabella, and the reference electrodes on the mastoids, with inter-electrode impedance maintained below 5 kΩ. Hearing loss severity was graded based on the wave V response threshold : normal hearing (< 20 dB nHL), mild (20–34 dB nHL), moderate (35–49 dB nHL), moderately severe (50–64 dB nHL), severe (65–79 dB nHL), profound (80–94 dB nHL), and complete hearing loss (≥ 95 dB nHL)[ 10 ]. For asymmetric hearing loss, classification was based on the worse ear. Auditory steady-state response(ASSR) : Electrode placement was identical to the ABR setup, using a two-channel recording mode. The stimulus was an NB CE-Chirp® tone, with carrier frequencies at 0.5, 1.0, 2.0, and 4.0 kHz. The initial presentation level was 50 dB nHL, and thresholds were determined using a "down-10, up-5" bracketing procedure. Acoustic Immittance Testing: A GSI TympStar middle ear analyzer (USA) was used with a 1000 Hz probe tone. A single-peaked (Type A) tympanogram was considered normal. Diagnostic DPOAE: This test was employed to assist in the evaluation of cochlear outer hair cell function. 2.4 Statistical Analysis All statistical analyses were performed using SPSS Statistics version 27.0 (IBM Corp., USA). Categorical variables were presented as frequencies and percentages, with group comparisons conducted using McNemar's test. Continuous and ordinal variables that did not follow a normal distribution were compared between groups using the Mann-Whitney U test. A two-tailed p-value of less than 0.05 was considered statistically significant for all analyses. 3. Results 3.1 Hearing Screening Outcomes Of the 15,818 newborns, 15,643 underwent the initial hearing screening, yielding an initial screening rate of 98.89%. The initial screening pass rate was 96.71% (15,129/15,643). A total of 514 infants did not pass the initial screening. Among them, 480 underwent rescreening, representing a rescreening rate of 93.39%. The pass rate for the rescreening stage was 66.46% (319/480). Subsequently, 161 infants were referred for diagnostic evaluation, of whom 69 completed the comprehensive audiological assessment, resulting in a referral follow-up rate of 42.86%. Ultimately, 46 cases were confirmed with hearing loss, corresponding to a detection rate of 2.94 per 1,000 screened newborns (46/15,643). The screening cascade is summarized in Fig. 1 . 3.2 Hearing Screening Results by Ear Screening outcomes by ear showed that 15,129 newborns passed bilaterally, 194 failed in both ears, and 320 had a unilateral refer (130 right ear only; 190 left ear only). McNemar's test confirmed a significantly higher overall pass rate in the right ear (97.93%) than in the left (97.55%) (χ² = 10.88, P < 0.001). 3.3 Hearing Screening Results by Sex The pass rate for male infants was 96.71% (8,472/8,760), while for female infants, it was 96.72% (6,657/6,883). No statistically significant difference in hearing screening pass rates was observed between males and females. 3.4 Audiological Diagnosis Analysis Among the 69 infants who underwent diagnostic audiological evaluation, 46 (27 males, 19 females) were confirmed with hearing loss. Detailed distributions of demographic characteristics, laterality, degree, and type of hearing loss are summarized in Table 1 . Unilateral hearing loss was predominant (26 cases, 56.52%), while bilateral loss accounted for 43.48% (20 cases). In terms of severity, mild and moderate hearing loss constituted the majority (34 cases, 73.91%), whereas moderately severe, severe, and profound hearing loss collectively accounted for 26.09% (12 cases). Regarding the type of loss, conductive hearing loss was more common (50.00%), followed by sensorineural hearing loss (47.83%). Table 1 Characteristics of Infants with Confirmed Hearing Loss (n = 46) Characteristic Category n Percentage (%) Sex Male 27 58.70 Female 19 41.30 Laterality Unilateral 26 56.52 Bilateral 20 43.48 Severity Mild 17 36.96 Moderate 17 36.96 Moderately Severe 3 6.52 Severe 1 2.17 Profound 8 17.39 Type Conductive 23 50.00 Sensorineural 22 47.83 Mixed 1 2.17 The degree of hearing loss was classified based on the more severely affected ear. 3.5 Genetic Testing Results Genetic testing for hearing loss was performed on 42 of the 46 infants. Results were normal in 38 cases, while pathogenic variants were identified in 4 cases. These included two cases of heterozygous GJB2 mutations, one case of homozygous GJB2 mutation, and one case of compound heterozygous mutations involving homozygous SLC26A4 and heterozygous GJB2. 3.6 Potential Risk Factors for Hearing Loss in Infants Among the 46 infants diagnosed with hearing loss, 65.22% (30/46) had mothers and 71.74% (33/46) had fathers over 30 years of age. Perinatal factors constituted the primary category of risk, including preterm birth (gestational age < 37 weeks, 14 cases, 30.43%), low birth weight (<2.5 kg, 8 cases, 17.39%), and neonatal hyperbilirubinemia (6 cases, 13.04%). Congenital anomalies and infectious factors were also notable, such as craniofacial anomalies (7 cases, 15.22%) and congenital cytomegalovirus infection (4 cases, 8.70%). Other factors, including severe neonatal asphyxia, abnormal brain development, and family history of hearing loss, are presented in Table 2 . Table 2 Risk Factors for Hearing Loss in Diagnosed Children(n = 46) Risk Factors for Hearing Loss n Percentage (%) Mother's Age > 30 years 30 65.22 ≤ 30 years 16 34.78 Father's Age >30 years 33 71.74 ≤30 years 13 28.26 Preterm Birth (Gestational Age < 37 weeks) 14 30.43 Low Birth Weight 8 17.39 Facial Dysmorphism 7 15.22 Neonatal Hyperbilirubinemia 6 13.04 Cytomegalovirus Intrauterine Infection 4 8.70 Severe Neonatal Asphyxia (NICU Hospitalization > 5 days) 3 6.52 Amniotic Fluid Aspiration 3 6.52 Abnormal Brain Development 2 4.35 Respiratory Distress Syndrome of the Newborn 2 4.35 Family History of Deafness 2 4.35 Other* 7 15.22 *Other:maternal diabetes during pregnancy, neonatal hypoglycemia,G6PD deficiency,pneumonia requiring hospitalization, cleft palate with atrial septal defect, and mechanical ventilation > 48 hours (1 case each). Some children presented with two or more coexisting risk factors. 3.7 Post-Diagnosis Intervention and Follow-up All 46 infants diagnosed with hearing loss received intervention within three months post-diagnosis, resulting in a 100% intervention rate. Follow-up was completed by 42 infants (follow-up rate: 91.30%). The four infants lost to follow-up all had unilateral or asymmetric hearing loss (including two with unilateral mild, one with unilateral moderate, and one with moderate hearing loss in one ear and mild loss in the contralateral ear). Telephone interviews with their families indicated age-appropriate auditory and speech development, and thus re-evaluation was not performed. The follow-up visits for the 42 infants occurred between 6 months and 2 years of age, with the highest frequency of visits concentrated at 6 months, 1 year, and 2 years. Among the 42 infants who completed follow-up, 10 (23.81%) demonstrated normalized hearing by 2 years of age, while 32 (76.19%) had persistent hearing loss. The severity distribution among these 32 infants was as follows: 16 mild, 6 moderate, 1 moderately severe, 1 severe, and 8 profound. A Mann-Whitney U test comparing the severity distributions at initial diagnosis and follow-up revealed a statistically significant difference (P < 0.05), indicating that the overall hearing loss severity was greater at initial diagnosis. The changes in hearing loss profiles are shown in Fig. 2 . 4. Discussion This study, through systematic hearing screening and follow-up of 15,818 newborns, delineates the epidemiological characteristics, associated risk factors, and outcomes of intervention for neonatal hearing loss in our region, providing critical clinical evidence for optimizing newborn hearing screening management strategies.The initial screening rate of 98.89% and rescreening rate of 93.39% indicate good program coverage, meeting the targets set by Chinese guidelines (initial screening rate ≥ 90%, rescreening rate ≥ 80%)[ 9 ]. The initial screening pass rate was 96.71%. A total of 46 infants were diagnosed with hearing loss, yielding a detection rate of 2.94 per 1,000, which aligns with the reported incidence range of 1–3 per 1,000 live births [ 3 – 5 , 10 – 11 ]. Notably, loss to follow-up occurred between the initial screening failure and completion of diagnostic testing (diagnostic referral rate: 42.86%), highlighting the need to strengthen follow-up management and improve tracking/recall systems to enhance overall program efficiency. Loss to follow-up at any stage can delay diagnosis, potentially missing the critical window for early intervention. Our results showed a significantly higher initial screening pass rate for the right ear (97.93%) compared to the left ear (97.55%). This right-ear advantage may reflect earlier maturation of the auditory system on the right side, consistent with documented multilevel asymmetries in the neonatal auditory pathway [ 12 ]. Potential mechanisms for this asymmetry involve both structural and neural pathways. Anatomically, the common left-anterior fetal position may cause greater retention of amniotic fluid, vernix, or secretions in the left ear, impeding sound conduction [ 13 ]. Alternatively, a neural mechanism is supported by evidence of left-right differences in medial olivocochlear bundle function [ 14 – 15 ]. Regarding sex, no significant difference in pass rates was found between males and females, consistent with the consensus that sex is not a major risk factor for hearing loss [ 16 ]. Among diagnosed infants, unilateral hearing loss (56.52%) was more frequent than bilateral loss, and the profile was predominantly mild-to-moderate (73.91%) and conductive (50.00%) in nature. This profile carries important clinical implications. First, it underscores the need to recognize that unilateral and mild-to-moderate losses can still impact speech clarity, learning ability, and sound localization in children [ 17 – 18 ]. Second, the high proportion of conductive losses suggests middle ear dysfunction (e.g., effusion) might be a common cause, which often resolves spontaneously or is medically treatable, explaining the hearing recovery observed in some infants during follow-up. The primary perinatal risk factors identified were preterm birth, low birth weight, and hyperbilirubinemia. Their pathophysiological mechanisms likely involve hypoxic-ischemic injury and bilirubin neurotoxicity affecting the auditory pathway [ 19 – 20 ]. Congenital anomalies (e.g., craniofacial anomalies) and intrauterine infections (e.g., CMV) also contributed significantly, suggesting a need for enhanced prenatal diagnosis and maternal infection screening [ 21 ]. A notable finding was the high proportion of parents over 30 years old. Although this study lacked a control group, this observation suggests parental age as a potential confounding factor warranting further investigation. Furthermore, a considerable number of cases (15.22%) were attributed to 'other' factors, often involving multiple coexisting risks, reflecting the etiological diversity and complexity of neonatal hearing loss, necessitating comprehensive clinical assessment. Genetic testing performed on 42 infants identified pathogenic variants in 4 cases (9.52%), involving GJB2 and SLC26A4 genes, consistent with the common spectrum of deafness-causing genes in China [ 22 ]. Notably, two of the genetically confirmed cases presented with profound sensorineural hearing loss, further reinforcing that genetic etiologies are a primary cause of severe, often poorly prognostic, hearing loss [ 23 – 25 ]. Therefore, for such infants, especially those lacking clear acquired risk factors, early genetic testing and counseling are crucial. This not only clarifies the etiology and estimates recurrence risk but also provides scientific basis for family planning guidance, representing a key step towards precision medicine. Dynamic analysis of hearing status from initial diagnosis to follow-up revealed a distinct dichotomous trend in outcomes. On one hand, hearing normalized in 10 infants (23.81%), primarily those with initial mild-to-moderate loss, likely due to resolution of transient middle ear dysfunction (e.g., effusion) or other reversible pathologies. This highlights the importance of systematic follow-up to identify reversible losses and avoid unnecessary intervention. On the other hand, hearing loss remained stable and significant in all infants initially diagnosed with severe-to-profound loss, consistent with the typically permanent nature of severe sensorineural hearing loss, often associated with irreversible hair cell damage or genetic defects [ 26 – 27 ].This evolutionary pattern significantly altered the case mix at follow-up: mild hearing loss became the most prevalent category, while the relative proportion of profound loss increased substantially, becoming the second most common category. This distribution is clinically significant. It indicates that after natural course filtering, the screening program ultimately identifies two main groups requiring ongoing management: a larger group with mild loss, typically responsive to intervention, and a smaller yet critically important group with severe-to-profound loss, demanding urgent, intensive, and costly rehabilitation. The latter group represents the focus and challenge for long-term clinical management and resource allocation. Of particular concern, loss to follow-up was concentrated among infants with unilateral or mild hearing loss, suggesting insufficient parental awareness of the potential consequences of these losses. This group should be a priority target for future education and follow-up system improvements. Despite its contributions, this study has limitations inherent to its single-center, descriptive design and participant attrition, which may affect generalizability and introduce bias. These constraints must be addressed through future multi-center, prospective studies with long-term follow-up to fully elucidate the natural history and intervention outcomes for these children. 5. Conclusion The Shenzhen cohort demonstrated a neonatal hearing loss detection rate of 2.94‰, consistent with established data. Notably, a disparity in hearing screening outcomes was observed, with a higher pass rate in the right ear. The predominant audiological phenotype consisted of unilateral, mild-to-moderate, and conductive hearing loss. Follow-up evaluation revealed a dichotomous trend, characterized by either spontaneous recovery or persistence of the deficit. This underscores the critical need for enhanced follow-up management between rescreening and diagnosis, and for the implementation of stratified, individualized intervention protocols. Declarations Fundings The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Author Contributions Yanmin Chen, Feiwei An designed the study, wrote the original draft of the manuscript, and reviewed and edited the manuscript.Yanmin Chen and Feiwei An administered the project; Yanmin Chen preprocessed, verified, and analyzed the data. All authors had final responsibility for the decision to submit for publication. Ethics Declaration The study was performed according to the principles expressed in the Declaration of Helsinki. The study was performed with the approval of the Shenzhen Maternity and Child Healthcare Hospital ethics committee. Informed Consent The patients' written informed consent was obtained from parents. Conflict of Interest The authors declare no conflicts of interest. Acknowledgements Not applicable. Consent for Publication Not applicable. Avalability of Data and Materials Data are available from the authors upon reasonable request. References Sontag MK, Yusuf C, Grosse SD, et al. Infants with congenital disorders identified through newborn screening - United States, 2015-2017. MMWR. Morbidity and Mortality Weekly Report, 2020, 69(36): 1265-1268. https://doi.org/10.15585/mmwr.mm6936a6 Thompson DC, McPhillips H, Davis RL, et al. Universal newborn hearing screening: summary of evidence. 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Development, 1999, 126(8): 1581-1590. https://doi.org/10.1242/dev.126.8.1581 Cite Share Download PDF Status: Published Journal Publication published 30 Dec, 2025 Read the published version in International Journal of Pediatric Otorhinolaryngology → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8110222","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":555339154,"identity":"cd630d39-3e5d-4b86-bb77-4c39a5099fb1","order_by":0,"name":"Yanmin 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03:27:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8110222/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8110222/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1016/j.ijporl.2025.112701","type":"published","date":"2025-12-31T00:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":97705690,"identity":"4f28eaf6-7b08-4bff-9ce8-444d711793cd","added_by":"auto","created_at":"2025-12-08 12:53:55","extension":"xml","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":6669,"visible":true,"origin":"","legend":"","description":"","filename":"itjpITJPD2501309.xml","url":"https://assets-eu.researchsquare.com/files/rs-8110222/v1/e74cb0bee79bb7b383e09039.xml"},{"id":97705672,"identity":"85ccb712-0825-4d03-81df-bf452538f6d1","added_by":"auto","created_at":"2025-12-08 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12:53:57","extension":"html","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":91265,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8110222/v1/0daefda52fd3634bb777388b.html"},{"id":97705653,"identity":"b96c2843-bf97-4ae3-93c0-3d569a74a1b6","added_by":"auto","created_at":"2025-12-08 12:53:54","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":76506,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of the hearing screening program for the neonatal cohort (N = 15,818).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8110222/v1/8cf9ed6879346cab36b254f0.png"},{"id":97705615,"identity":"804061b5-bcb9-4e44-acc4-9c8c34088e19","added_by":"auto","created_at":"2025-12-08 12:53:53","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":24523,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8110222/v1/c6fea7ef6cc17e1999e5a4c4.png"},{"id":106959603,"identity":"09c0d029-206c-4d5b-bc74-18abdffa5ff6","added_by":"auto","created_at":"2026-04-15 09:12:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1175770,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8110222/v1/b7dcd4f4-b586-457f-8bba-025d02c12d14.pdf"}],"financialInterests":"","formattedTitle":"Newborn Hearing Screening to Diagnosis: A Clinical Study of 15,818 Cases","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eCongenital hearing loss (CHL) ranks among the most common birth defects and represents the most frequently diagnosed condition through newborn disease screening programs [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The reported global incidence of neonatal hearing loss ranges between 1 and 3 per 1,000 live births [\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Normal auditory function is a fundamental prerequisite for language acquisition, with typically hearing infants entering a critical period for language development between 4 and 9 months of age, which should not extend beyond 11 months. Robust clinical evidence has confirmed that early identification and diagnosis of hearing loss before 6 months of age, followed by prompt and scientifically guided intervention, can significantly mitigate its long-term adverse effects on speech [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], cognitive, social, and psychological-behavioral development, thereby substantially improving long-term outcomes [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe implementation of universal newborn hearing screening (UNHS) has laid the groundwork for the early detection, diagnosis, and intervention of CHL. Since China issued the \"Guidelines for Early Hearing Assessment and Intervention in Newborns and Infants\" in 2009, the national screening system has been progressively refined [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, the overall effectiveness of UNHS depends not only on high initial screening coverage but also critically on the seamless linkage between subsequent stages\u0026mdash;diagnosis, intervention, and long-term follow-up. In practice, significant challenges remain, including the loss to follow-up between the initial screening and confirmatory diagnosis, as well as regional variations in the audiological characteristics and etiological profiles of hearing loss.\u003c/p\u003e\u003cp\u003eShenzhen, a modern metropolis characterized by a large migrant population and a high annual number of births, provides a regionally representative context for investigating the epidemiological profile of CHL. Therefore, this study analyzed hearing screening and follow-up data from 15,818 newborns delivered at Shenzhen Maternity and Child Healthcare Hospital between January and December 2022. The aims were to determine the local detection rate, delineate the clinical and audiological characteristics, and identify the associated risk factors of neonatal hearing loss in this population. The findings are expected to provide localized evidence for optimizing screening management protocols and enhancing intervention efficacy.\u003c/p\u003e"},{"header":"2. Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Study Participants\u003c/h2\u003e\u003cp\u003eThis retrospective study included 15,818 live-born neonates delivered at Shenzhen Maternity and Child Healthcare Hospital between January and December 2022. From this cohort, 15,643 newborns who completed the initial hearing screening were included in the final analysis. The study population comprised 8,760 males and 6,883 females.\u003c/p\u003e\u003cp\u003e Prior to any screening procedures, written informed consent was obtained from all participants' parents or guardians. The study protocol was approved by the Shenzhen Maternity and Child Healthcare Hospital Ethics Committee.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Hearing Screening Protocol\u003c/h2\u003e\u003cp\u003eInitial hearing screening was performed using distortion product otoacoustic emissions (DPOAE) after 48 hours of birth but before hospital discharge, in an environment with ambient noise levels below 45 dB. Screening was conducted using a Danish International Hearing Otoacoustic Emissions analyzer. The stimulus intensities were set at L1\u0026thinsp;=\u0026thinsp;45 dB SPL and L2\u0026thinsp;=\u0026thinsp;55 dB SPL, with a frequency ratio f2/f1\u0026thinsp;=\u0026thinsp;1.22. The test covered six frequency points (0.5, 1, 2, 3, 4, and 6 kHz). A \"PASS\" result was defined as responses present in at least four of the six frequencies; otherwise, the result was recorded as \"REFER.\" Infants who failed the initial screening were scheduled for rescreening around 42 days after birth using a combination of DPOAE and automated auditory brainstem response (AABR).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Audiological Diagnostic Procedures\u003c/h2\u003e\u003cp\u003eInfants who did not pass the rescreening were referred for a comprehensive audiological diagnostic assessment at a corrected age of 3 months. Prior to testing, all subjects underwent routine otoscopic examination by an otolaryngologist to inspect the ear canal and remove any cerumen if present. To ensure accurate results, natural sleep was induced by oral administration of 10% chloral hydrate solution (50 mg/kg) before testing commenced in a standard sound-attenuated booth. The diagnostic test battery included:\u003c/p\u003e\u003cp\u003eAuditory brainstem response (ABR): Testing was performed using the Danish International Hearing Eclipse evoked potential system with insert earphones. Stimulus parameters included alternating polarity clicks presented at a rate of 17.7 times per second, with 1000 sweeps averaged and a bandpass filter of 100\u0026ndash;3000 Hz. Electrode montage placed the recording electrode at the hairline, the ground electrode at the glabella, and the reference electrodes on the mastoids, with inter-electrode impedance maintained below 5 kΩ. Hearing loss severity was graded based on the wave V response threshold : normal hearing (\u0026lt;\u0026thinsp;20 dB nHL), mild (20\u0026ndash;34 dB nHL), moderate (35\u0026ndash;49 dB nHL), moderately severe (50\u0026ndash;64 dB nHL), severe (65\u0026ndash;79 dB nHL), profound (80\u0026ndash;94 dB nHL), and complete hearing loss (\u0026ge;\u0026thinsp;95 dB nHL)[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. For asymmetric hearing loss, classification was based on the worse ear.\u003c/p\u003e\u003cp\u003eAuditory steady-state response(ASSR) : Electrode placement was identical to the ABR setup, using a two-channel recording mode. The stimulus was an NB CE-Chirp\u0026reg; tone, with carrier frequencies at 0.5, 1.0, 2.0, and 4.0 kHz. The initial presentation level was 50 dB nHL, and thresholds were determined using a \"down-10, up-5\" bracketing procedure.\u003c/p\u003e\u003cp\u003eAcoustic Immittance Testing: A GSI TympStar middle ear analyzer (USA) was used with a 1000 Hz probe tone. A single-peaked (Type A) tympanogram was considered normal.\u003c/p\u003e\u003cp\u003eDiagnostic DPOAE: This test was employed to assist in the evaluation of cochlear outer hair cell function.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Statistical Analysis\u003c/h2\u003e\u003cp\u003eAll statistical analyses were performed using SPSS Statistics version 27.0 (IBM Corp., USA). Categorical variables were presented as frequencies and percentages, with group comparisons conducted using McNemar's test. Continuous and ordinal variables that did not follow a normal distribution were compared between groups using the Mann-Whitney U test. A two-tailed p-value of less than 0.05 was considered statistically significant for all analyses.\u003c/p\u003e\u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003e3.1 Hearing Screening Outcomes\u003c/h2\u003e\n \u003cp\u003eOf the 15,818 newborns, 15,643 underwent the initial hearing screening, yielding an initial screening rate of 98.89%. The initial screening pass rate was 96.71% (15,129/15,643). A total of 514 infants did not pass the initial screening. Among them, 480 underwent rescreening, representing a rescreening rate of 93.39%. The pass rate for the rescreening stage was 66.46% (319/480). Subsequently, 161 infants were referred for diagnostic evaluation, of whom 69 completed the comprehensive audiological assessment, resulting in a referral follow-up rate of 42.86%. Ultimately, 46 cases were confirmed with hearing loss, corresponding to a detection rate of 2.94 per 1,000 screened newborns (46/15,643). The screening cascade is summarized in Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003e3.2 Hearing Screening Results by Ear\u003c/h2\u003e\n \u003cp\u003eScreening outcomes by ear showed that 15,129 newborns passed bilaterally, 194 failed in both ears, and 320 had a unilateral refer (130 right ear only; 190 left ear only). McNemar\u0026apos;s test confirmed a significantly higher overall pass rate in the right ear (97.93%) than in the left (97.55%) (\u0026chi;\u0026sup2; = 10.88, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003e3.3 Hearing Screening Results by Sex\u003c/h2\u003e\n \u003cp\u003eThe pass rate for male infants was 96.71% (8,472/8,760), while for female infants, it was 96.72% (6,657/6,883). No statistically significant difference in hearing screening pass rates was observed between males and females.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003e3.4 Audiological Diagnosis Analysis\u003c/h2\u003e\n \u003cp\u003eAmong the 69 infants who underwent diagnostic audiological evaluation, 46 (27 males, 19 females) were confirmed with hearing loss. Detailed distributions of demographic characteristics, laterality, degree, and type of hearing loss are summarized in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. Unilateral hearing loss was predominant (26 cases, 56.52%), while bilateral loss accounted for 43.48% (20 cases). In terms of severity, mild and moderate hearing loss constituted the majority (34 cases, 73.91%), whereas moderately severe, severe, and profound hearing loss collectively accounted for 26.09% (12 cases). Regarding the type of loss, conductive hearing loss was more common (50.00%), followed by sensorineural hearing loss (47.83%).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eCharacteristics of Infants with Confirmed Hearing Loss (n\u0026thinsp;=\u0026thinsp;46)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eCharacteristic\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eCategory\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePercentage (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSex\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e27\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e58.70\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e41.30\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eLaterality\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eUnilateral\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e26\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e56.52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eBilateral\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e20\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e43.48\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSeverity\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMild\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e17\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e36.96\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eModerate\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e17\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e36.96\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eModerately Severe\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e6.52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSevere\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e2.17\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eProfound\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e17.39\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eType\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eConductive\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e23\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e50.00\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSensorineural\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e22\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e47.83\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMixed\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e2.17\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cstrong\u003eThe degree of hearing loss was classified based on the more severely affected ear.\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003e3.5 Genetic Testing Results\u003c/h2\u003e\n \u003cp\u003eGenetic testing for hearing loss was performed on 42 of the 46 infants. Results were normal in 38 cases, while pathogenic variants were identified in 4 cases. These included two cases of heterozygous GJB2 mutations, one case of homozygous GJB2 mutation, and one case of compound heterozygous mutations involving homozygous SLC26A4 and heterozygous GJB2.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003e3.6 Potential Risk Factors for Hearing Loss in Infants\u003c/h2\u003e\n \u003cp\u003eAmong the 46 infants diagnosed with hearing loss, 65.22% (30/46) had mothers and 71.74% (33/46) had fathers over 30 years of age. Perinatal factors constituted the primary category of risk, including preterm birth (gestational age\u0026thinsp;\u0026lt;\u0026thinsp;37 weeks, 14 cases, 30.43%), low birth weight (\u0026lt;2.5 kg, 8 cases, 17.39%), and neonatal hyperbilirubinemia (6 cases, 13.04%). Congenital anomalies and infectious factors were also notable, such as craniofacial anomalies (7 cases, 15.22%) and congenital cytomegalovirus infection (4 cases, 8.70%). Other factors, including severe neonatal asphyxia, abnormal brain development, and family history of hearing loss, are presented in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eRisk Factors for Hearing Loss in Diagnosed Children(n\u0026thinsp;=\u0026thinsp;46)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eRisk Factors for Hearing Loss\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePercentage (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMother\u0026apos;s Age\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e\u0026gt;\u0026thinsp;30 years\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e65.22\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026le;\u0026thinsp;30 years\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e16\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e34.78\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eFather\u0026apos;s Age\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026gt;30 years\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e33\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e71.74\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026le;30 years\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e13\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e28.26\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePreterm Birth\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(Gestational Age\u0026thinsp;\u0026lt;\u0026thinsp;37 weeks)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e14\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e30.43\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eLow Birth Weight\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e17.39\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eFacial Dysmorphism\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e15.22\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eNeonatal Hyperbilirubinemia\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e13.04\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCytomegalovirus Intrauterine Infection\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e8.70\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSevere Neonatal Asphyxia (NICU Hospitalization\u0026thinsp;\u0026gt;\u0026thinsp;5 days)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e6.52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAmniotic Fluid Aspiration\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e6.52\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAbnormal Brain Development\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e4.35\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eRespiratory Distress Syndrome of the Newborn\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e4.35\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eFamily History of Deafness\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e4.35\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eOther*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u003cstrong\u003e15.22\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cstrong\u003e*Other:maternal diabetes during pregnancy, neonatal hypoglycemia,G6PD deficiency,pneumonia requiring hospitalization, cleft palate with atrial septal defect, and mechanical ventilation\u0026thinsp;\u0026gt;\u0026thinsp;48 hours (1 case each). Some children presented with two or more coexisting risk factors.\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n \u003ch2\u003e3.7 Post-Diagnosis Intervention and Follow-up\u003c/h2\u003e\n \u003cp\u003eAll 46 infants diagnosed with hearing loss received intervention within three months post-diagnosis, resulting in a 100% intervention rate. Follow-up was completed by 42 infants (follow-up rate: 91.30%). The four infants lost to follow-up all had unilateral or asymmetric hearing loss (including two with unilateral mild, one with unilateral moderate, and one with moderate hearing loss in one ear and mild loss in the contralateral ear). Telephone interviews with their families indicated age-appropriate auditory and speech development, and thus re-evaluation was not performed. The follow-up visits for the 42 infants occurred between 6 months and 2 years of age, with the highest frequency of visits concentrated at 6 months, 1 year, and 2 years.\u003c/p\u003e\n \u003cp\u003eAmong the 42 infants who completed follow-up, 10 (23.81%) demonstrated normalized hearing by 2 years of age, while 32 (76.19%) had persistent hearing loss. The severity distribution among these 32 infants was as follows: 16 mild, 6 moderate, 1 moderately severe, 1 severe, and 8 profound. A Mann-Whitney U test comparing the severity distributions at initial diagnosis and follow-up revealed a statistically significant difference (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05), indicating that the overall hearing loss severity was greater at initial diagnosis. The changes in hearing loss profiles are shown in Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis study, through systematic hearing screening and follow-up of 15,818 newborns, delineates the epidemiological characteristics, associated risk factors, and outcomes of intervention for neonatal hearing loss in our region, providing critical clinical evidence for optimizing newborn hearing screening management strategies.The initial screening rate of 98.89% and rescreening rate of 93.39% indicate good program coverage, meeting the targets set by Chinese guidelines (initial screening rate\u0026thinsp;\u0026ge;\u0026thinsp;90%, rescreening rate\u0026thinsp;\u0026ge;\u0026thinsp;80%)[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. The initial screening pass rate was 96.71%. A total of 46 infants were diagnosed with hearing loss, yielding a detection rate of 2.94 per 1,000, which aligns with the reported incidence range of 1\u0026ndash;3 per 1,000 live births [\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Notably, loss to follow-up occurred between the initial screening failure and completion of diagnostic testing (diagnostic referral rate: 42.86%), highlighting the need to strengthen follow-up management and improve tracking/recall systems to enhance overall program efficiency. Loss to follow-up at any stage can delay diagnosis, potentially missing the critical window for early intervention.\u003c/p\u003e\u003cp\u003eOur results showed a significantly higher initial screening pass rate for the right ear (97.93%) compared to the left ear (97.55%). This right-ear advantage may reflect earlier maturation of the auditory system on the right side, consistent with documented multilevel asymmetries in the neonatal auditory pathway [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Potential mechanisms for this asymmetry involve both structural and neural pathways. Anatomically, the common left-anterior fetal position may cause greater retention of amniotic fluid, vernix, or secretions in the left ear, impeding sound conduction [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Alternatively, a neural mechanism is supported by evidence of left-right differences in medial olivocochlear bundle function [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Regarding sex, no significant difference in pass rates was found between males and females, consistent with the consensus that sex is not a major risk factor for hearing loss [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAmong diagnosed infants, unilateral hearing loss (56.52%) was more frequent than bilateral loss, and the profile was predominantly mild-to-moderate (73.91%) and conductive (50.00%) in nature. This profile carries important clinical implications. First, it underscores the need to recognize that unilateral and mild-to-moderate losses can still impact speech clarity, learning ability, and sound localization in children [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Second, the high proportion of conductive losses suggests middle ear dysfunction (e.g., effusion) might be a common cause, which often resolves spontaneously or is medically treatable, explaining the hearing recovery observed in some infants during follow-up.\u003c/p\u003e\u003cp\u003eThe primary perinatal risk factors identified were preterm birth, low birth weight, and hyperbilirubinemia. Their pathophysiological mechanisms likely involve hypoxic-ischemic injury and bilirubin neurotoxicity affecting the auditory pathway [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Congenital anomalies (e.g., craniofacial anomalies) and intrauterine infections (e.g., CMV) also contributed significantly, suggesting a need for enhanced prenatal diagnosis and maternal infection screening [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. A notable finding was the high proportion of parents over 30 years old. Although this study lacked a control group, this observation suggests parental age as a potential confounding factor warranting further investigation. Furthermore, a considerable number of cases (15.22%) were attributed to 'other' factors, often involving multiple coexisting risks, reflecting the etiological diversity and complexity of neonatal hearing loss, necessitating comprehensive clinical assessment.\u003c/p\u003e\u003cp\u003eGenetic testing performed on 42 infants identified pathogenic variants in 4 cases (9.52%), involving GJB2 and SLC26A4 genes, consistent with the common spectrum of deafness-causing genes in China [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Notably, two of the genetically confirmed cases presented with profound sensorineural hearing loss, further reinforcing that genetic etiologies are a primary cause of severe, often poorly prognostic, hearing loss [\u003cspan additionalcitationids=\"CR24\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Therefore, for such infants, especially those lacking clear acquired risk factors, early genetic testing and counseling are crucial. This not only clarifies the etiology and estimates recurrence risk but also provides scientific basis for family planning guidance, representing a key step towards precision medicine.\u003c/p\u003e\u003cp\u003eDynamic analysis of hearing status from initial diagnosis to follow-up revealed a distinct dichotomous trend in outcomes. On one hand, hearing normalized in 10 infants (23.81%), primarily those with initial mild-to-moderate loss, likely due to resolution of transient middle ear dysfunction (e.g., effusion) or other reversible pathologies. This highlights the importance of systematic follow-up to identify reversible losses and avoid unnecessary intervention. On the other hand, hearing loss remained stable and significant in all infants initially diagnosed with severe-to-profound loss, consistent with the typically permanent nature of severe sensorineural hearing loss, often associated with irreversible hair cell damage or genetic defects [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].This evolutionary pattern significantly altered the case mix at follow-up: mild hearing loss became the most prevalent category, while the relative proportion of profound loss increased substantially, becoming the second most common category. This distribution is clinically significant. It indicates that after natural course filtering, the screening program ultimately identifies two main groups requiring ongoing management: a larger group with mild loss, typically responsive to intervention, and a smaller yet critically important group with severe-to-profound loss, demanding urgent, intensive, and costly rehabilitation. The latter group represents the focus and challenge for long-term clinical management and resource allocation.\u003c/p\u003e\u003cp\u003eOf particular concern, loss to follow-up was concentrated among infants with unilateral or mild hearing loss, suggesting insufficient parental awareness of the potential consequences of these losses. This group should be a priority target for future education and follow-up system improvements.\u003c/p\u003e\u003cp\u003eDespite its contributions, this study has limitations inherent to its single-center, descriptive design and participant attrition, which may affect generalizability and introduce bias. These constraints must be addressed through future multi-center, prospective studies with long-term follow-up to fully elucidate the natural history and intervention outcomes for these children.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eThe Shenzhen cohort demonstrated a neonatal hearing loss detection rate of 2.94\u0026permil;, consistent with established data. Notably, a disparity in hearing screening outcomes was observed, with a higher pass rate in the right ear. The predominant audiological phenotype consisted of unilateral, mild-to-moderate, and conductive hearing loss. Follow-up evaluation revealed a dichotomous trend, characterized by either spontaneous recovery or persistence of the deficit. This underscores the critical need for enhanced follow-up management between rescreening and diagnosis, and for the implementation of stratified, individualized intervention protocols.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFundings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eYanmin Chen, Feiwei An designed the study, wrote the original draft of the manuscript, and reviewed and edited the manuscript.Yanmin Chen and Feiwei An administered the project; Yanmin Chen preprocessed, verified, and analyzed the data. All authors had final responsibility for the decision to submit for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics Declaration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was performed according to the principles expressed in the Declaration of Helsinki. The study was performed with the approval of the Shenzhen Maternity and Child Healthcare Hospital ethics committee.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed Consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe patients' written informed consent was obtained from parents.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflicts of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for Publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvalability of Data and Materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData are available from the authors upon reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSontag MK, Yusuf C, Grosse SD, et al. Infants with congenital disorders identified through newborn screening - United States, 2015-2017. MMWR. Morbidity and Mortality Weekly Report, 2020, 69(36): 1265-1268. https://doi.org/10.15585/mmwr.mm6936a6\u003c/li\u003e\n\u003cli\u003eThompson DC, McPhillips H, Davis RL, et al. Universal newborn hearing screening: summary of evidence. JAMA, 2001, 286(16): 2000-2010. https://doi.org/10.1001/jama.286.16.2000\u003c/li\u003e\n\u003cli\u003eFinitzo T, Albright K, O\u0026apos;Neal J. The newborn with hearing loss: detection in the nursery. Pediatrics, 1998, 102(6): 1452-1460. https://doi.org/10.1542/peds.102.6.1452\u003c/li\u003e\n\u003cli\u003eMorton CC, Nance WE. Newborn hearing screening--a silent revolution. New England Journal of Medicine, 2006, 354(20): 2151-2164. https://doi.org/10.1056/NEJMra050700\u003c/li\u003e\n\u003cli\u003eSchwarz Y, Mauthner R, Kraus O, et al. Newborn hearing screening: early ear examination improves the pass rate. The Journal of International Advanced Otology, 2023, 19(5): 402-406. https://doi.org/10.5152/iao.2023.22987\u003c/li\u003e\n\u003cli\u003eYoshinaga-Itano C, Coulter D, Thomson V. The Colorado Newborn Hearing Screening Project: effects on speech and language development for children with hearing loss. Journal of Perinatology, 2000, 20(8 Pt 2): S132-S137. https://doi.org/10.1038/sj.jp.7200438\u003c/li\u003e\n\u003cli\u003ePipp-Siegel S, Sedey AL, VanLeeuwen AM, et al. Mastery motivation and expressive language in young children with hearing loss. Journal of Deaf Studies and Deaf Education, 2003, 8(2): 133-145. https://doi.org/10.1093/deafed/eng008\u003c/li\u003e\n\u003cli\u003eYoshinaga-Itano C, Sedey AL, Coulter D., et al. Language of early- and later-identified children with hearing loss. Pediatrics, 1998, 102(5): 1161-1171. https://doi.org/10.1542/peds.102.5.1161\u003c/li\u003e\n\u003cli\u003eAudiology Group, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association; Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery. Guideline on early hearing detection and intervention in newborns and infants (draft). Chinese Journal of Otorhinolaryngology Head and Neck Surgery, 2009, 44(11): 883-888. In Chinese.\u003c/li\u003e\n\u003cli\u003eWorld Health Organization. World report on hearing. World Health Organization; 2021. Available from: https://www.who.int/publications/i/item/9789240020481\u003c/li\u003e\n\u003cli\u003eJakub\u0026iacute;kov\u0026aacute; J, Kab\u0026aacute;tov\u0026aacute; Z, Pavlovcinov\u0026aacute; G, et al. Newborn hearing screening and strategy for early detection of hearing loss in infants. International Journal of Pediatric Otorhinolaryngology, 2009, 73(4): 607-612. https://doi.org/10.1016/j.ijporl.2008.12.006\u003c/li\u003e\n\u003cli\u003eRoth DA, Hildesheimer M, Roziner I, et al. Evidence for a right-ear advantage in newborn hearing screening results.Trends in Hearing, 2016, 20: 2331216516681168. https://doi.org/10.1177/2331216516681168\u003c/li\u003e\n\u003cli\u003ePrieve BA, Hancur-Bucci CA, Preston JL. Changes in transient-evoked otoacoustic emissions in the first month of life.Ear and Hearing, 2009, 30(3): 330-339. https://doi.org/10.1097/AUD.0b013e31819c4000\u003c/li\u003e\n\u003cli\u003eThornton AR, Kimm L, Kennedy CR. Methodological factors involved in neonatal screening using transient-evoked otoacoustic emissions and automated auditory brainstem response testing. Hearing Research, 2003, 182(1-2): 65-76. https://doi.org/10.1016/S0378-5955(03)00173-4\u003c/li\u003e\n\u003cli\u003eBurns EM, Arehart KH, Campbell SL. Prevalence of spontaneous otoacoustic emissions in neonates. The Journal of the Acoustical Society of America, 1992, 91(3): 1571-1575. https://doi.org/10.1121/1.402438\u003c/li\u003e\n\u003cli\u003eMeyer C, Witte J, Hildmann A, et al. Neonatal screening for hearing disorders in infants at risk: incidence, risk factors, and follow-up.Pediatrics, 1999, 104(4): 900-904. https://doi.org/10.1542/peds.104.4.900\u003c/li\u003e\n\u003cli\u003eFitzpatrick EM, Whittingham J, Durieux-Smith A. Mild bilateral and unilateral hearing loss in childhood: a 20-year view of hearing characteristics, and audiologic practices before and after newborn hearing screening.Ear and Hearing, 2014, 35(1): 10-18. https://doi.org/10.1097/AUD.0b013e31829e1ed9\u003c/li\u003e\n\u003cli\u003eCorbin NE, Buss E, Leibold LJ. Spatial hearing and functional auditory skills in children with unilateral hearing loss. Journal of Speech, Language, and Hearing Research, 2021, 64(11): 4495-4512. https://doi.org/10.1044/2021_JSLHR-20-00081\u003c/li\u003e\n\u003cli\u003eMaqbool M, Najar BA, Gattoo I, et al. Screening for hearing impairment in high risk neonates: a hospital based study. Journal of Clinical and Diagnostic Research, 2015, 9(6): SC18-SC21. https://doi.org/10.7860/JCDR/2015/14509.6104\u003c/li\u003e\n\u003cli\u003eZeng QX, Luo RZ, Yan SB, et al. Screening strategy and time points for newborn hearing re-screening with high risk factors. World Journal of Otorhinolaryngology-Head and Neck Surgery, 2022, 8(3): 257-261. https://doi.org/10.1016/j.wjorl.2020.09.002\u003c/li\u003e\n\u003cli\u003eSzyfter K, Gawęcki W, Szyfter W. Newborn hearing screening-Polish experience: a narrative review. Journal of Clinical Medicine, 2025, 14(8): 2789. https://doi.org/10.3390/jcm14082789\u003c/li\u003e\n\u003cli\u003eWang QJ, Zhao YL, Rao SQ, et al. Newborn hearing concurrent gene screening can improve care for hearing loss: a study on 14,913 Chinese newborns. International Journal of Pediatric Otorhinolaryngology, 2011, 75(4): 535-542. https://doi.org/10.1016/j.ijporl.2011.01.016\u003c/li\u003e\n\u003cli\u003eMahboubi H, Dwabe S, Fradkin M, et al. Genetics of hearing loss: where are we standing now?.European Archives of Oto-Rhino-Laryngology, 2012, 269(7): 1733-1745. https://doi.org/10.1007/s00405-011-1910-6\u003c/li\u003e\n\u003cli\u003eSnoeckx RL, Huygen PL, Feldmann D, et al. GJB2 mutations and degree of hearing loss: a multicenter study. The American Journal of Human Genetics, 2005, 77(6): 945-957. https://doi.org/10.1086/497996\u003c/li\u003e\n\u003cli\u003eEverett LA, Glaser B, Beck JC, et al. Pendred syndrome is caused by mutations in a putative sulphate transporter gene (PDS).Nature Genetics, 1997, 17(4): 411-422. https://doi.org/10.1038/ng1297-411\u003c/li\u003e\n\u003cli\u003evan Beeck Calkoen EA, Engel MSD, van de Kamp JM, et al. The etiological evaluation of sensorineural hearing loss in children. European Journal of Pediatrics, 2019, 178(8): 1195-1205. https://doi.org/10.1007/s00431-019-03379-8\u003c/li\u003e\n\u003cli\u003eChen P, Segil, N. p27(Kip1) links cell proliferation to morphogenesis in the developing organ of Corti. Development, 1999, 126(8): 1581-1590. https://doi.org/10.1242/dev.126.8.1581\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Newborn Hearing Screening, Hearing Loss, Risk Factors, Detection Rate, Follow-Up Studies, Intervention Strategies","lastPublishedDoi":"10.21203/rs.3.rs-8110222/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8110222/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective: \u003c/strong\u003eTo analyze the epidemiological characteristics, risk factors, and follow-up outcomes of neonatal hearing loss, thereby providing a basis for optimizing screening and intervention strategies.\u003cbr\u003e\n \u003cstrong\u003eMethods:\u003c/strong\u003e A total of 15,818 newborns born at Shenzhen Maternity and Child Healthcare Hospital between January and December 2022 were enrolled. Initial screening was conducted using distortion product otoacoustic emissions (DPOAE). Infants who referred underwent rescreening with a combination of DPOAE and automated auditory brainstem response(AABR), and those who failed were referred for comprehensive diagnostic evaluation at 3 months of age, including auditory brainstem response(ABR), auditory steady-state response(ASSR), and acoustic immittance testing. Pass rates and loss-to-follow-up rates at each stage were analyzed, along with the characteristics and risk factors of confirmed hearing loss.\u003cbr\u003e\n \u003cstrong\u003eResults:\u003c/strong\u003e Of the cohort, 15,643 newborns completed the initial screening, with a pass rate of 96.71%. Forty-six cases were confirmed with hearing loss, yielding a detection rate of 2.94 per 1,000. The pass rate for the right ear (97.93%) was significantly higher than for the left ear (97.55%) (P \u0026lt; 0.001). Among the diagnosed cases, hearing loss was predominantly unilateral (56.52%), mild-to-moderate in degree (73.91%), and conductive in type (50.00%). The primary risk factors identified were preterm birth (30.43%), low birth weight (17.39%), craniofacial anomalies (15.22%), and hyperbilirubinemia (13.04%). Follow-up and genetic testing were completed for 42 infants. Pathogenic variants in GJB2 or SLC26A4 genes were identified in 4 cases (9.52%). Hearing returned to normal in 10 infants (23.81%), while the hearing status of those with severe-to-profound loss remained stable. A significant difference was observed in the distribution of hearing loss between the initial diagnosis and follow-up (P \u0026lt; 0.05).\u003cbr\u003e\n \u003cstrong\u003eConclusion:\u003c/strong\u003e This study found a neonatal hearing loss detection rate consistent with previous reports, observed a higher screening pass rate in the right ear. The hearing loss was predominantly unilateral and mild-to-moderate, with follow-up revealing a dichotomous trend of either spontaneous recovery or persistence. This pattern highlights the necessity of enhancing follow-up management during the critical window between rescreening and diagnosis, and of formulating stratified and individualized intervention and follow-up protocols.\u003c/p\u003e","manuscriptTitle":"Newborn Hearing Screening to Diagnosis: A Clinical Study of 15,818 Cases","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-08 12:53:25","doi":"10.21203/rs.3.rs-8110222/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"bf2b511d-1f13-425e-b431-cafee2848cba","owner":[],"postedDate":"December 8th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T13:30:12+00:00","versionOfRecord":{"articleIdentity":"rs-8110222","link":"https://doi.org/10.1016/j.ijporl.2025.112701","journal":{"identity":"international-journal-of-pediatric-otorhinolaryngology","isVorOnly":true,"title":"International Journal of Pediatric Otorhinolaryngology"},"publishedOn":"2025-12-31 00:00:00","publishedOnDateReadable":"December 31st, 2025"},"versionCreatedAt":"2025-12-08 12:53:25","video":"","vorDoi":"10.1016/j.ijporl.2025.112701","vorDoiUrl":"https://doi.org/10.1016/j.ijporl.2025.112701","workflowStages":[]},"version":"v1","identity":"rs-8110222","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8110222","identity":"rs-8110222","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}