Despite published guidelines from the Health Professions Council of South Africa (HPCSA, 2018) on the importance of early hearing detection and intervention (EHDI), standardised implementation of newborn and infant hearing screening (NIHS) in South Africa remains missing to date (Bezuidenhout et al., 2021). The HPCSA guidelines recommend diagnosis of hearing loss and enrolment in early intervention programmes by a maximum of 8 months of age (2018). Although there is growing awareness of the need for EHDI in South Africa, clear legislation mandating NIHS remains absent (Bezuidenhout et al., 2021; De Kock et al., 2016). National surveys conducted in both the private and public healthcare sectors of South Africa suggest screening of only 10% of infants, leaving approximately 90% of newborns with no access to hearing screening (Meyer et al., 2012; Theunissen & Swanepoel, 2008). The public healthcare sector in South Africa services approximately 85% of the general population, but only 7.5% of public facilities offer NIHS services, of which less than 1% offer universal screening (Theunissen & Swanepoel, 2008). Resultantly, reports regarding average age at diagnosis of hearing loss range between 23 months and 44.5 months (Kuschke et al., 2020; Van der Spuy & Pottas, 2008). Late identification of hearing loss implies limited access to early auditory stimulation, which is crucial for age-appropriate speech and language development in children (Olusanya, 2012). Recent evidence continues to demonstrate delayed identification of this abnormality in children. A systematic review by Phanguphangu et al. (2025) reported persistent late detection of congenital hearing loss in South Africa. Studies carried out in KwaZulu-Natal and Gauteng provinces highlight risk-based rather than universal implementation models (Khan & Joseph, 2024; Kanji & Khoza-Shangase, 2021). Community-based pilot programmes suggest that integration into immunisation platforms may be feasible (Kgare & Joubert, 2024; Phanguphangu & Ross, 2025), but large-scale implementation remains limited. Within the Western Cape province, one earlier study profiled childhood hearing loss and associated risk factors (Kuschke et al., 2020), yet limited published data describe contemporary screening outcomes within the public tertiary sector. As South Africa is classified as an upper-middle-income country (World Bank, 2025) with substantial inequities in healthcare access, understanding implementation patterns at tertiary referral centres may provide crucial insights into systemic bottlenecks and opportunities for strengthening early detection pathways. Currently, two NIHS-endorsed techniques exist: Otoacoustic emissions (OAEs) and automated auditory brainstem responses (AABRs) (HPCSA, 2018). The OAE technique measures cochlear outer hair cell functioning and is the most frequently used method for well-baby screening in South Africa (HPCSA, 2018). The AABR method measures neural synchrony of the eighth cranial nerve and lower brainstem and is used for screening in high-risk infants and those who are at risk for auditory neuropathy spectrum disorder (HPCSA, 2018). Evidence is lacking about the status of NIHS programmes in the private and public healthcare sectors in South Africa (Bezuidenhout et al., 2021). Available evidence suggests limited success achieved within existing programmes (Maluleke et al., 2018; Swanepoel et al., 2009). Even in the private healthcare sector of South Africa, where resource constraints are less severe, significant delay is observed in the diagnosis and intervention of childhood hearing loss (Khoza-Shangase et al., 2010; Khoza-Shangase & Kanji, 2021; Meyer et al., 2014). Currently, no legislation mandates the implementation of universal NIHS in South Africa (Bezuidenhout et al., 2021; Khoza-Shangase & Kanji, 2021). Screening is primarily risk-based and targeted at babies and young children who present with known risk factors for hearing loss. Targeted hearing screening is not ideal in contexts where risk factors for hearing loss remain poorly documented (Khoza-Shangase et al., 2017). A recent profile of childhood hearing loss in the Western Cape province revealed that in a sample of 240 children, nearly one-third (27.1%) of those with sensorineural hearing loss (SNHL) had no risk factors, highlighting the need for universal screening coverage (Kuschke et al., 2020). A study conducted in two South African provinces revealed a lack of standardised NIHS implementation at primary, secondary and tertiary levels of public healthcare (Khoza-Shangase et al., 2017). Some of the reasons for the sporadic implementation included limited access to equipment and human resources, financial constraints, and a lack of commitment and political will by the South African government to mandate NIHS. These findings, together with geographical barriers, poverty, long travelling distances and associated costs to attend appointments, have highlighted the need for more context-specific studies regarding NIHS to ensure that contextually relevant strategies are formulated to promote early detection, identification and intervention for hearing loss in children (Khoza-Shangase et al., 2017). This study therefore aimed to describe NIHS outcomes and implementation patterns at a tertiary paediatric hospital in the Western Cape, South Africa.

The total number of patients under 6 years who were seen at RCWMCH Audiology from August 2019 to August 2024 was 7871. Of those, only 511 (6.5%) had documented NIHS results, so they were enrolled in the study sample.

The current study provides an updated perspective on the implementation and outcomes of NIHS at a tertiary paediatric hospital in the Western Cape province, South Africa. It evaluates data over a 5-year period. Several key findings highlight both progress and persistent gaps in achieving EHDI benchmarks. The advanced mean age of initial NIHS (16.3 months) emphasises that ‘newborn’ hearing screening in South Africa often occurs well beyond infancy. This delayed occurrence diminishes the opportunity for timely auditory stimulation and speech-language development, thereby highlighting an urgent need for system-level interventions to shift NIHS schedules closer to the neonatal period. The mean age of diagnosis in this cohort, 15.6 months, is earlier than in previous reports from South Africa, in which participants’ age ranged between 18 months and 44.5 months (Kuschke et al., 2020; Swanepoel et al., 2013; Van der Spuy & Pottas, 2008). Nonetheless, this downward trend is encouraging; the current findings remain well outside both the internationally recommended 1-3-6 benchmark (screening by 1 month, diagnosis by 3 months, and intervention by 6 months) and the locally adapted 2-4-8 benchmark proposed for low-income and middle-income contexts (HPCSA, 2018; Olusanya et al., 2014). Analysis of risk factors revealed predominance of neurological (41.1%) and infectious (25.2%) aetiologies in the study sample. These categories included cerebral palsy, hypoxic ischaemic encephalopathy, bacterial meningitis, rubella and cytomegalovirus infections. Such findings mirror the South African epidemiological profile, in which different perinatal complications and infectious diseases remain major contributors to paediatric morbidity (Kehoe, 2025). The significant burden of preventable infections, such as rubella and meningitis, highlights the importance of strengthening vaccination coverage, maternal health programmes, and infection-control practices as complementary strategies to NIHS implementation (Olusanya, 2012). The distribution of referral facilities illustrates another systemic challenge. The majority of children (60.7%) were referred from tertiary facilities, with only 10% referred from primary healthcare centres. This anomalous pattern reflects a disproportionate reliance on higher levels of care, where audiological resources and diagnostic equipment are concentrated, rather than on primary-level MOUs, where universal access could be more effectively achieved. Strengthening NIHS at the primary-care level is essential to reduce inequities in access and ensure earlier identification across the population. Some strategies for strengthening hearing services at the primary care level include training staff on hearing loss risk factors, improved and consistent use of the Road to Health Booklet, early management of middle ear pathology, and clear referral pathways (World Health Organization, 2021). The lifetime economic burden of one annual birth cohort of unidentified infant hearing loss is estimated at R68.6 billion (about R1bn per year of life). The national EHDI programme aligns with national health insurance priorities and supports better educational and employment outcomes (World Health Organization, 2021). Screening outcomes provide further insights into implementation challenges. Nearly half of children (45.2%) were referred on their initial NIHS, yet 40% were later found to have normal bilateral hearing on diagnostic assessment. This discrepancy likely reflects the predominant use of OAE during initial screening, coupled with the older age at which screening occurred. By 16 months of age, middle ear effusions are common, leading to elevated false-positive rates when OAE is employed as the sole screening tool. At repeat screening, where AABR methods were used in approximately 60% of cases, the referral rate decreased considerably to 1.1%. These results corroborate the earlier international literature and validate that AABR is less susceptible to the effects of transient middle ear pathology and environmental noise (Norton et al., 2000; White et al., 2005). The RCWMCH protocol, in which infants who fail OAE screening are rescreened with AABR before their referral for further diagnostics, aligns with best practices and the apparent decreased referral rate on rescreens in this sample. However, the advanced age at initial screening in this cohort diminishes these benefits, because older infants are more vulnerable to otitis media with effusion and other confounding conditions. Diagnostic outcomes also provide important contextual insights. One in five children presented with CHL, thus reflecting the high burden of middle ear disease in low-resource contexts, where recurrent infections and limited access to timely medical care are prevalent (World Health Organization, 2021). Mild and moderate degrees of hearing loss were most common, emphasising the need for greater vigilance in detection, as these degrees can still significantly impact speech and language development if left unmanaged. A notable proportion (20%) of children had an undetermined hearing loss type, which demonstrates the challenges encountered in completing comprehensive diagnostic assessments in young children. Contributing factors likely included fatigue, poor cooperation during behavioural tests, and discharging ears that precluded bone conduction testing. These challenges highlight the importance of strengthening capacity for objective diagnostic measures, such as Auditory brainstem response (ABR), especially in children younger than 3 years or those with complex medical conditions.

The results of this study unravel both progress and persistent gaps in NIHS method in the Western Cape. Though the age of diagnosis is decreasing, the delay in initial screening, the over-representation of tertiary referrals, and the reliance on OAE at older ages all limit the effectiveness of current approaches. These results align with some previous South African studies that describe sporadic, resource-dependent, and non-standardised implementation of NBHS (Khoza-Shangase et al., 2017; Maluleke et al., 2018). Therefore, achieving meaningful improvement will require a shift towards universal screening at the primary level, increased use of AABR in high-risk or older infants, and parallel strengthening of public health measures that address infectious and perinatal risk factors.

Although the mean age of diagnosis was lower in the current study than previously reported in South Africa, it remains substantially delayed compared to international and local EHDI benchmarks. A high proportion of referrals originated from tertiary facilities, revealing inherent weaknesses in the integration of NIHS at the primary care level, where universal access is most feasible. Infectious and neurological risk factors are the most common contributors to hearing loss, consistent with South Africa’s broader child health context. Screening outcomes revealed a high initial referral rate when the OAE approach was used at older ages, but this was mitigated by subsequent AABR rescreening. These findings highlight both encouraging trends and ongoing barriers. To move closer to timely identification and intervention, South Africa requires standardised NIHS protocols, stronger integration of screening at the primary care level, greater use of AABR technology, and complementary strategies to reduce preventable infectious and perinatal risk factors. Overall, we can conclude that sustainable system-level investment and policy support are needed to ensure equitable access to EHDI for all children.