Safety of the HyperSound® Audio System in subjects with normal hearing
AbstractThe objective of the study was to assess the safety of the HyperSound® Audio System (HSS), a novel audio system using ultrasound technology, in normal hearing subjects under normal use conditions; we considered preexposure and post-exposure test design. We investigated primary and secondary outcome measures: i) temporary threshold shift (TTS), defined as >10 dB shift in pure tone air conduction thresholds and/or a decrement in distortion product otoacoustic emissions (DPOAEs) >10 dB at two or more frequencies; ii) presence of new-onset otologic symptoms after exposure. Twenty adult subjects with normal hearing underwent a pre-exposure assessment (pure tone air conduction audiometry, tympanometry, DPOAEs and otologic symptoms questionnaire) followed by exposure to a 2-h movie with sound delivered through the HSS emitter followed by a post-exposure assessment. No TTS or new-onset otological symptoms were identified. HSS demonstrates excellent safety in normal hearing subjects under normal use conditions.
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Copyright (c) 2015 Ritvik P. Mehta, Sara L. Mattson, Brian A. Kappus, Robin L. Seitzman
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