An interventional study of Non-invasive bone conduction hearing aid A and Non-invasive bone conduction hearing aid B in Hearing Loss, Conductive, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sequence: 1. Aided with non-invasive bone conduction hearing aid A 2. Aided with non-invasive bone conduction hearing aid B
Device: Non-invasive bone conduction hearing aid A · Device: Non-invasive bone conduction hearing aid B
Sequence: 1. Aided with non-invasive bone conduction hearing aid B 2. Aided with non-invasive bone conduction hearing aid A
Device: Non-invasive bone conduction hearing aid A · Device: Non-invasive bone conduction hearing aid B
The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.
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.
Speech reception threshold in noise (S0NDIFF)
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.
Time frame: Day 1
Speech reception threshold in noise (S90NDIFF)
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.
Time frame: Day 1
Speech reception threshold in noise (S270NDIFF)
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.
Time frame: Day 1
Sound localization
Mean absolute localization error (in degrees)
Time frame: Day 1
Subjective evaluation of the sound quality
Assessment of the sound quality with questionnaire by Gabrielsson et al.
Time frame: Day 1
Plan to share: Undecided
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern