MB11 BERAphone and Auditory Brainstem Response in newborns at audiologic risk: Comparison of results

Objective: To compare the diagnostic effectiveness of Automated Auditory Brainstem Responses (MB11 technique) with that of standard Auditory Brainstem Responses (ABR) in a sample of newborns evaluated after the second month of life. Methods: From October 2002 to February 2005, audiologic evaluations were performed in full-term newborns who presented altered otoacoustic emissions and in newborns considered at audiologic risk admitted to the ENT (Ear Nose Throat) Unit of Giannina Gaslini Institute, Genoa, Italy. Our sample included 201 children (104 males and 97 females) who underwent on the same day an audiologic test using MB11 BERAphone Maico and standard ABR test. Results: Out of the 388 ears examined, 378 (97.4%) showed agreement between the two techniques, whereas in 10 (2.6%) there was no agreement. Interobserver agreement was excellent (kappa = 0.92 ± 0.02 S.E., p = 0.0001). The MB11 test yielded no false negatives and 10 false positives which resulted normal at ABR. The MB11 test showed very good specificity 96.8% (95% CI 94.8-98.7%) and sensitivity 100% (95% CI 93.9-100%), positive predictive value 88.2% (95% CI 79-93.9%) and negative predictive value 100% (95% CI 98.4-100%) for diagnosis of hearing loss. Conclusions: The results obtained confirm the absolute validity of MB11 screening test in subjects at audiologic risk. Furthermore, the test can be used to esclude normal hearing subjects (threshold 40 dB HL) and to refer hearing loss subjects to subsequent ABR for diagnosis.