Hearing Loss, Conductive
Conditions
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.
Interventions
DEVICENon-invasive bone conduction hearing aid A
The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.
DEVICENon-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 adhesive adapter that is placed behind the auricle.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech reception threshold in noise (S0NDIFF) | 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
| Measure | Time frame | Description |
|---|---|---|
| Speech reception threshold in noise (S90NDIFF) | 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) | 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 | Day 1 | Mean absolute localization error (in degrees) |
| Subjective evaluation of the sound quality | Day 1 | Assessment of the sound quality with questionnaire by Gabrielsson et al. |
Countries
Switzerland
Outcome results
None listed