Clinical Trial: Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Brief Summary:

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.


Detailed Summary:
Sponsor: University Hospital Inselspital, Berne

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • Sound localization [ Time Frame: Day 1 ]
    Mean absolute localization error (in degrees)
  • Subjective evaluation of the sound quality [ Time Frame: Day 1 ]
    Assessment of the sound quality with questionnaire by Gabrielsson et al.


Original Secondary Outcome: Same as current

Information By: University Hospital Inselspital, Berne

Dates:
Date Received: April 19, 2017
Date Started: May 2017
Date Completion: July 2017
Last Updated: April 26, 2017
Last Verified: April 2017