Hearing loss prevalence is increasing, with an estimated 2.5 billion people affected globally by 2050. Scalable service delivery models using innovative technologies and task-shifting are World Health Organization priorities to improve access to hearing care, particularly in low- and middle-income countries. Smartphone-facilitated audiometry in the community using hearing aids covered by noise-attenuating ear cups ("in-situ") could support more accessible hearing care when provided by less trained individuals such as community health workers (CHWs). This study aimed to determine the validity of this method for potential hearing aid fitting. Study objectives included determining the maximum permissible ambient noise level (MPANL), inter-device reliability, clinical threshold accuracy, reliability, and performance in real-world settings. Experiment 1: 15 normal-hearing adult participants were evaluated to determine MPANLs for circumaural Peltor 3M earcups covering Lexie Lumen hearing aids with smartphone-facilitated in-situ audiometry. MPANLs were calculated by measuring the difference in attenuation between thresholds obtained with standard headphones and in-situ hearing aids. Experiment 2: Pure-tone frequency and intensity output of 14 same-model Lexie Lumen hearing aids were measured to determine inter-device reliability. Pure-tone stimuli were measured and analyzed to determine sound pressure levels in decibels and pure-tone frequency when connected to a test box 2cc coupler. Experiment 3: 85 adult participants were tested in a sound booth to determine the accuracy of automated in-situ pure-tone audiometry (PTA) compared to clinical PTA (500, 1000, 2000, 3000, 4000, 6000 Hz) facilitated by an audiologist. The first 39 participants were tested twice to determine test-retest reliability. Experiment 4: In a community setting, 144 adult participants were tested with automated in-situ audiometry facilitated by CHWs using a smartphone app. These participants were subsequently tested with automated mobile PTA (500, 1000, 2000, 4000 Hz). An additional 44 participants were tested twice to determine test-retest reliability. Experiment 1: MPANLs of the Peltor 3M earcup-covered hearing aids were higher than standard headphones across all frequencies, ranging from 24 to 47.3 dB SPL. Experiment 2: Inter-device performance reliability was high, with all inter-device differences across all intensities and frequencies less than 3 dB. Frequency output was consistent and differed less than 0.7% between devices. Experiments 3 and 4: 85.2% and 83.3% of automated in-situ audiometry thresholds were within 10 dB of thresholds obtained in the sound booth and in a community setting, respectively. Acceptable test-retest intraclass correlation coefficient (ICC) was evident across all thresholds obtained in a sound booth (ICC = 0.85 to 0.93) and in a community setting (ICC = 0.83 to 0.97). Smartphone-facilitated in-situ audiometry allows for reliable and valid community-based testing. A simple smartphone user interface and automated in-situ audiometry allow CHWs with minimal training to facilitate the testing. With the additional capability to program hearing aids via the smartphone after the initial test, this approach would have the potential to support widespread access to personalized hearing aid fittings facilitated by CHWs in low- and middle-income countries. This approach also supports self-fitting options based on in-situ thresholds, enabling testing and fitting via over the counter hearing aids.
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