ABR-based newborn hearing screening with MB11 BERAphone® using an optimized chirp for acoustical stimulation.

OBJECTIVE: At our center, the Maico MB11 BERAphone(®) device is used for newborn hearing screening based on Auditory Brainstem Responses (ABR). In 2006, an optimized chirp stimulus was implemented in the device to increase the reliability and quality of the screening method. In 2002, an automated response detection algorithm had been implemented. This study analyzes the screening results using the MB11 BERAphone(®) device with the implemented chirp stimulus and automated response detection method.
METHODS: The data presented were collected in the well-baby nursery as part of the newborn hearing screening program following a two stage screening protocol. To focus the study on the typical routine screening, data from at-risk babies were not included. Overall, data from 6866 babies (3604 males and 3262 females) screened from March 2006 to April 2011 were analyzed in this study.
RESULTS: Out of the 6866 babies screened, 6607 passed bilaterally prior to hospital discharge (defined as 1st stage in this hearing screening program). Therefore, the pre-discharge pass rate of the hearing screening with the MB11 BERAphone(®) device was 96.2%. The resulting referral rate was 3.8%. The median test time per ear (excluding time for preparation and data reporting) was 28s with a range of 15-112s (5-95th percentile). The number of infants referred for 2nd stage, post-discharge re-screening was 259. Of this group, 71 passed bilaterally and 188 failed the re-screening in one or both ears. Therefore, including both the pre-discharge and post-discharge screening results, the bilateral pass rate was 97.3% and 2.7% were referred for diagnostic evaluation. Diagnostic testing was performed on all of the 188 infants who were referred. Results showed that 47 of these babies had hearing loss. This equates to a positive predictive value for a refer result of 25%. The observed prevalence of hearing impairment in our population was 0.684%. Diagnostic results for 141 of the referred newborns proved that they had normal hearing. That is, 141 out of 6866 newborns had a false-positive result with the MB11 BERAphone(®) screening. Therefore, the device had a specificity of 97.9%. During the time period of this study, no baby who passed the hearing screening was later found to have hearing impairment, suggesting a sensitivity of 100%. However, due to the limited number of newborns and the short time period after screening for the more recently screened babies, a reliable estimate of the sensitivity cannot be yet made from our program statistics. The theoretical sensitivity of the MB 11 device is 99.9%.
CONCLUSIONS: The Maico MB11 BERAphone(®) is a reliable device for auditory brainstem response newborn hearing screening and it provides results within a very short time. Due to the implemented method for automatic detection of ABR, the use of the device does not require an experienced examiner, allowing it to be used by trained technicians in locations outside the department of audiology such as the well-baby nursery.