Audiological Benefit With Non-implantable Bone Conduction Hearing Systems
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss, Conductive
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Speech reception threshold in noise (S0NDIFF)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Speech reception threshold in noise (S90NDIFF)(Day 1)
- Subjective evaluation of the sound quality(Day 1)
- Speech reception threshold in noise (S270NDIFF)(Day 1)
- Sound localization(Day 1)