MedPath

The Effects of Ultrasonic Noise Exposure on Human Hearing

Not Applicable
Completed
Conditions
Hearing Loss
Interventions
Other: Ultrasonic noise exposure
Diagnostic Test: Pure Tone Audiometry
Registration Number
NCT03515928
Lead Sponsor
Ultrahaptics Ltd
Brief 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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
Inclusion Criteria
  • Adult, audiometrically healthy
Exclusion Criteria
  • Underlying/pre-existing hearing impairment

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Noise Exposed GroupUltrasonic noise exposure-
Noise Exposed GroupPure Tone Audiometry-
Control GroupPure Tone Audiometry-
Primary Outcome Measures
NameTimeMethod
Temporary Threshold Shifts (TTS)Audiometry will be conducted immediately (with 2 hours) from noise exposure

Mild and recoverable hearing loss in sensitivity due to noise exposure will be checked for statistical significance using paired and independent t-test.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ultrahaptics

🇬🇧

Bristol, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath