title: Safety of the HyperSound® Audio System in Subjects with Normal Hearing.
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.
authors.affiliation: California Hearing &Balance Center La Jolla , CA, USA.
authors.forename: Ritvik P
authors.initials: RP
authors.lastname: Mehta
authors.affiliation: California Hearing &Balance Center La Jolla , CA, USA.
authors.forename: Sara L
authors.initials: SL
authors.lastname: Mattson
authors.affiliation: Turtle Beach Corporation , Poway, CA, USA.
authors.forename: Brian A
authors.initials: BA
authors.lastname: Kappus
authors.affiliation: Seitzman Consulting , San Diego, CA, USA.
authors.forename: Robin L
authors.initials: RL
authors.lastname: Seitzman
keywords: Hypersound®; directional audio; ultrasonic hearing; ultrasound safety