Comparison between MB11 BERAphone® and ALGO2e color for hearing screening in Japanese healthy newborns

Background: Since 2001, newborn hearing screening has been performed in Japan.Objective: This study compared newborn hearing screening results between the MAICO MB11 BERAphone (MB11) and the Natus ALGO2e color (ALGO) Automated Auditory Brainstem Response (AABR) devices among healthy Japanese newborns.Materials and methods: From December 2014 to April 2018, 1477 healthy newborns were screened by MB11 and 267 by ALGO. Data from at-risk newborns were not included. Outcomes were 'Pass' and 'Refer' rates, specificity, false-positive rates, and assessment duration. Infants with a Refer result were examined using Interacoustics Eclipse.Results: MB11 identified 1425 (96.5%) as Pass and 52 (3.5%) as Refer. ALGO identified 263 (98.5%) as Pass and four (1.5%) as Refer. Specificity and false-positive rates were 97.7% and 2.3% for MB11 and 98.5% and 1.5% for ALGO, respectively. Using MB11, the total mean assessment time was 320.2 +/- 220.7 s, with 315.6 +/- 214.2 s for Pass and 628.6 +/- 288.8 s for Refer.Conclusions: MB11 is useful for hearing screening in healthy Japanese newborns and is fast and easy to operate. MB11 showed high specificity equivalent to ALGO.