NCT03515928

The Effects of Ultrasonic Noise Exposure on Human Hearing

An Investigation of the Effects of Ultrasonic Noise Exposure on the Human Auditory System Via Pure Tone Audiometry (PTA) on Audiometrically Healthy Volunteers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ultrahaptics Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. A cohort of 20 audiometrically healthy volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity, at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A subgroup of 10 subjects will be used as a control group. The resulting audiograms will establish the extent of any recoverable loss in hearing sensitivity known as temporary threshold shifts (TTS).

Conditions

• Hearing Loss

Interventions

Type	Name	Description
OTHER	Ultrasonic noise exposure	Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.
DIAGNOSTIC_TEST	Pure Tone Audiometry	Participants will undergo 2 (pre and post exposure) hearing tests

Timeline

• Start date: 2018-10-15
• Primary completion: 2018-11-21
• Completion: 2018-11-21
• First posted: 2018-05-04
• Last updated: 2018-12-13

Locations

1 site across 1 country: United Kingdom