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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB arm | Active Comparator | Sequence:
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| BA arm | Active Comparator | Sequence:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Speech reception threshold in noise (S270NDIFF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Kompis, Prof | University Hospital Bern, Inselsptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearing Research Laboratory, University Hospital Bern | Bern | 3008 | Switzerland |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 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. |
|
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. |
| Day 1 |
| Sound localization | Mean absolute localization error (in degrees) | Day 1 |
| Subjective evaluation of the sound quality | Assessment of the sound quality with questionnaire by Gabrielsson et al. | Day 1 |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |