Abstract
The 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 pre-exposure 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.
Highlights
The 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
All subjects had normal hearing, normal middle ear function on tympanometry, with present distortion product otoacoustic emissions (DPOAEs) from 1500-6000 Hz on pre-exposure testing
Following exposure to a 113-min movie with audio played through the HSS emitter, Post-Exposure testing showed no significant changes in pure tone hearing thresholds or DPOAE thresholds
Summary
The 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. HSS demonstrates excellent safety in normal hearing subjects under normal use conditions
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