The effects of ultrasonic noise exposure on human hearing

  • Research type

    Research Study

  • Full title

    An investigation of the effects of ultrasonic noise exposure on the human auditory system via pure tone audiometry (PTA) on audiologically healthy volunteers.

  • IRAS ID

    245492

  • Contact name

    Andrew Di Battista

  • Contact email

    andrew.di.battista@ultrahaptics.com

  • Sponsor organisation

    Ultrahaptics Ltd

  • Clinicaltrials.gov Identifier

    NCT03515928

  • Duration of Study in the UK

    0 years, 1 months, 1 days

  • Research summary

    The aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). There is a growing use of ultrasonic transducers and sensors in modern technologies and consumer devices; often the public is unaware of any exposure to ultrasound, hence it may pose a public health risk.

    There is currently insufficient, up-to-date scientific evidence to fully support the assortment of international guidelines governing ultrasound exposure limits. Indeed, many reference sources are contradictory, and date back over half a century. Hence, there is a growing demand for new scientific investigations.

    The study will involve exposing a cohort (group) of healthy adult volunteers to an ultrasonic noise source for approximately 30 minutes. Before exposure, participants will have undergone Pure Tone Audiometry (PTA) (i.e. a hearing test) to establish a baseline for their hearing sensitivity. After exposure to ultrasound noise, participants will undergo a second hearing test. By comparing the before-and-after audiograms, the extent of temporary threshold shift (TTS), slight and recoverable hearing loss, can be measured. A placebo (dummy) group will also undergo testing (with the noise source switched off), in order to establish the statistical significance of the results. According to all present research, TTS is expected to be mild if not totally unappreciable for the noise levels used in this experiment.

    The results will be compared to current international guidelines and serve to advise on ultrasonic exposure safety. They will also guide future research in terms of setting appropriate exposure levels (intensity and duration).

    The study will be managed and run from Ultrahaptics Ltd, a Bristol based ultrasonic technology company. Audiometry will be conducted by a licensed practitioner in an NHS/private clinic. It is anticipated to begin in April 2018 and last no more than a month (from recruitment to the final hearing test).

  • REC name

    South West - Frenchay Research Ethics Committee

  • REC reference

    18/SW/0140

  • Date of REC Opinion

    30 Aug 2018

  • REC opinion

    Further Information Favourable Opinion