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Completed

NCT Number: NCT03129191

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss.

An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.

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Key information

Conditions

Hearing Loss, Conductive Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearing Research Laboratory, University Hospital Bern

Bern, 3008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Adults (age ≥ 18 years on the test date)
  • Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
  • German native speakers
  • Willingness and ability to perform all tests required for the study

Exclusion criteria

  • Lack of compliance with any inclusion criteria
  • Allergy against silicon (ear mold casting mass)

Treatment and study plan

Non-invasive bone conduction hearing aid A

Device

The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.

Non-invasive bone conduction hearing aid B

Device

The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle.

Primary outcomes

  1. Speech reception threshold in noise (S0NDIFF)

    Time frame: Day 1

    Speech reception threshold in noise (in dB SNR) measured with speech presented from the front (0° azimuth) and approximated diffuse noise presented from 4 speakers.

Secondary outcomes

  1. Speech reception threshold in noise (S90NDIFF)

    Time frame: Day 1

    Speech reception threshold in noise (in dB SNR) measured with speech presented from the right side (90° azimuth) and approximated diffuse noise presented from 4 speakers.

  2. Speech reception threshold in noise (S270NDIFF)

    Time frame: Day 1

    Speech reception threshold in noise (in dB SNR) measured with speech presented from the left side (270° azimuth) and approximated diffuse noise presented from 4 speakers.

  3. Sound localization

    Time frame: Day 1

    Mean absolute localization error (in degrees)

  4. Subjective evaluation of the sound quality

    Time frame: Day 1

    Assessment of the sound quality with questionnaire by Gabrielsson et al.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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