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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03515928

Enrollment

Registered

2018-05-04

Start date

2018-10-15

Completion date

2018-11-21

Last updated

2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Ultrasound, Hearing

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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).

Interventions

OTHERUltrasonic noise exposure

Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.

DIAGNOSTIC_TESTPure Tone Audiometry

Participants will undergo 2 (pre and post exposure) hearing tests

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult, audiometrically healthy

Exclusion criteria

* Underlying/pre-existing hearing impairment

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026