Abstract
BACKGROUND: The prevalence of hearing loss in infants in India varies between 4 and 5 per 1000. Objective-based otoacoustic emissions and auditory brainstem response have been used in high-income countries for establishing early hearing screening and intervention programs. Nevertheless, the use of objective screening tests in low- and middle-income countries (LMICs) such as India is not feasible. Mobile health (mHealth) solutions have been demonstrated to be a viable option for hearing screening in LMICs. OBJECTIVE: This study aims to develop and beta-validate an affordable hearing screener for children younger than 6 years of age to identify moderately severe or higher degrees of hearing loss. METHODS: In phase 1, a mHealth-based hearing screener (SRESHT) was developed using a single board computer with wireless commercial headphones and speakers as transducers, which were calibrated according to the standard procedure. Three subjective hearing screening modules were conceptualized and developed for different age groups: (1) behavioral observation audiometry-screening for infants aged from 0 to 1 year; (2) speech spectrum awareness task-screening for children 1 to 3 years old; and (3) speech recognition task-screening for children 3 to 6 years old. Different auditory stimuli for the screening modules were generated and suitability was assessed: (1) noisemakers, animal sounds, and environmental sounds for infants (birth to 1 year old); (2) animal sounds and nonsense syllables for children (1 to 3 years old); and (3) eighteen picturable spondee words for children (3 to 6 years old). In phase 2, the SRESHT screener was beta-validated in children aged below 6 years to establish the agreement between SRESHT modules and the gold-standard procedure in identifying moderately severe and higher degrees of hearing loss. RESULTS: Off-the-shelf commercial speakers and headphones were selected and calibrated. On comparison of stimuli for behavioral observation audiometry on 15 children, Noisemaker stimuli were found suitable based on the average minimum response levels. On comparison of different stimuli for speech spectrum awareness task on 15 children, animal sounds were found to be suitable. On familiarity check of 18 spondee words for speech recognition task among 20 children, 12 spondee words had the eligibility cutoff (85%) and a presentation level of 5 dB SL (re-pure tone threshold) was sufficient to achieve 80% psychometric function. In phase 2, a total of 55 children aged 0 to 6 years (31 normal hearing and 24 hearing impairment) underwent SRESHT screening for beta validation. Cohen κ indicated that the overall SRESHT screener had a very good agreement (κ=0.82) with gold-standard audiometric screening for identifying moderately severe and higher degrees of hearing loss. CONCLUSIONS: The development and beta validation of the SRESHT screener using the selected auditory stimuli showed that the stimuli were suitable for screening children.