Sensitivity and specificity of BERAphone® as a screening tool for neonatal hearing loss in a tertiary care hospital in India

Hearing loss is a silent crippling sensory disorder of childhood. If left undiagnosed it can result in speech, hearing and communication problems. Early detection through screening as recommended in the universal screening protocol is mandatory. The present study was done to evaluate the effectiveness of the screening tool BERAphone when it is used to screen high volumes of babies in the natural ward setting with background noise. Our study had used the updated version of the MB 11 device which is known to increase the amplitude of the ABR response using a chirp stimulus. These studies were carried out on healthy newborns who did not present with any particular audiologic risk factors within the first days of life. The present report shows the data analysis from 37 newborns screened using the MB11 BERAphone® as a screening tool. The first stage of the two staged hearing screening was performed in the postnatal ward and the second stage in the audiology lab. After the two stage screening the pass rate was 41.9% and the referral rate was 58.1%. The screening tool BERAphone showed a sensitivity of 92.86%, a specificity of 50%, positive predictive value of 30.23 % and negative predictive value 96.77% for the diagnosis of hearing loss. The results that were obtained show that MB11 is a good screening tool among infants and can be used as a first level diagnostic tool for suspected hearing loss but must be verified with Auditory Brainstem Response (ABR) which is the “gold standard” test essential to a correct neonatal screening programme. CONCLUSION: From our experience, the MB11 BERAphone® is a reliable device for use in a two stage newborn hearing screening based on auditory brainstem response. It gives good results within a very short time with minimal cost of materials since no disposables are necessary to be used compared to other ABR screening devices. Due to the implemented automated detection algorithm for ABR, the device is suitable for use by trained technicians in a post natal environment. The machine shows good specificity as predicted where it is able to identify those who do not have the disease but it has a low sensitivity than expected when used in the ward setting with surrounding high ambient noise. Thus it must be used along with a confirmatory test like ABR to establish hearing loss