Safety of the HyperSound® Audio System in Subjects with Normal Hearing

Area of Science:

• Audiology
• Acoustic Engineering
• Biomedical Engineering

Background:

• Novel audio systems utilizing ultrasound technology require rigorous safety assessments.
• Understanding the audiological impact of new sound delivery methods is crucial for public health.

Purpose of the Study:

• To evaluate the safety of the HyperSound® Audio System (HSS) in individuals with normal hearing.
• To assess potential auditory effects, including temporary threshold shift (TTS) and new otologic symptoms, following HSS exposure.

Main Methods:

• A pre-exposure and post-exposure study design was employed.
• Twenty adult subjects with normal hearing underwent audiometry, tympanometry, distortion product otoacoustic emissions (DPOAEs) testing, and symptom questionnaires.
• Subjects were exposed to a 2-hour movie using the HSS.

Main Results:

• No instances of temporary threshold shift (TTS) were detected in any subject.
• No new-onset otologic symptoms were reported by participants after HSS exposure.
• Distortion product otoacoustic emissions (DPOAEs) remained stable, indicating no cochlear dysfunction.

Conclusions:

• The HyperSound® Audio System (HSS) demonstrates excellent safety for normal hearing subjects under typical usage conditions.
• Ultrasound-based audio technology presents a safe alternative for sound delivery without adverse audiological effects.