Enhanced auditory brainstem response device (Vivosonic Integrity) in young children, in the child's home and hospital.

Objective: To evaluate the performance of an enhanced Auditory Brainstem Response (ABR) device (Vivosonic Integrity) in testing the hearing of young children under two years of age in the child's home or in a hospital.

Design: A prospective observational study for assessing ABR thresholds in children aged between 18 months and 2 years of age. The ABR tests were performed at home or in a regular hospital consultation room without soundproofing adaptations or electromagnetic shielding.

Study sample: Hearing was assessed in a total of 31 children (mean age 21.4 ± 3 months), with 20 tested at home and 11 in a hospital setting. These children, all with a congenital cytomegalovirus (cCMV) infection, were participants in the CONCERT-trial (ClinicalTrials.gov Identifier: NCT02005822).

Results: In 20 children tested at home, conclusive hearing thresholds were established at the first attempt in 91.7% of tested ears and in 100% following a second attempt. The first attempt was conclusive in all hospital-tested children.

Conclusions: Conclusive ABR results are achievable with the Vivosonic Integrity in young children under 2 years of age in home and hospital settings, even when awake, restless, talking, eating, drinking or watching television. This eliminates the need for sleep deprivation, sedation or general anaesthesia.