Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Study Overview
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Brief Summary
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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.

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

Conditions
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Hearing Loss, Conductive

Intervention / Treatment
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* Device: Non-invasive bone conduction hearing aid A
* Device: Non-invasive bone conduction hearing aid B


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AB arm<br>Sequence: Aided with non-invasive bone conduction hearing aid A Aided with non-invasive bone conduction hearing aid B | Device: Non-invasive bone conduction hearing aid A<br>* The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.<br>Device: Non-invasive bone conduction hearing aid B<br>* 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.<br>|
| Active Comparator: BA arm<br>Sequence: Aided with non-invasive bone conduction hearing aid B Aided with non-invasive bone conduction hearing aid A | Device: Non-invasive bone conduction hearing aid A<br>* The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.<br>Device: Non-invasive bone conduction hearing aid B<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |