The Effects of Ultrasonic Noise Exposure on Human Hearing

Ultrahaptics

Status: Completed

Conditions: Hearing Loss

Treatments: Diagnostic Test: Pure Tone Audiometry; Other: Ultrasonic noise exposure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03515928

UH-PAN-001

Details and patient eligibility

About

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult, audiometrically healthy

Exclusion criteria

• Underlying/pre-existing hearing impairment

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Noise Exposed Group

Active Comparator group

Treatment:

Diagnostic Test: Pure Tone Audiometry

Other: Ultrasonic noise exposure

Control Group

Placebo Comparator group

Treatment:

Diagnostic Test: Pure Tone Audiometry