Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Not Applicable

Completed

• Conditions: Hearing Loss, Conductive
• Interventions: Device: Non-invasive bone conduction hearing aid A; Device: Non-invasive bone conduction hearing aid B

• Registration Number: NCT03129191
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2017-07-01
• Status Verified: 2017-11
• Primary Completion: 2017-11-06
• Study Completion: 2017-11-06
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AB arm	Non-invasive bone conduction hearing aid B	Sequence: 1. Aided with non-invasive bone conduction hearing aid A 2. Aided with non-invasive bone conduction hearing aid B
AB arm	Non-invasive bone conduction hearing aid A	Sequence: 1. Aided with non-invasive bone conduction hearing aid A 2. Aided with non-invasive bone conduction hearing aid B
BA arm	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
BA arm	Non-invasive bone conduction hearing aid A	Sequence: 1. Aided with non-invasive bone conduction hearing aid B 2. Aided with non-invasive bone conduction hearing aid A

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Subjective evaluation of the sound quality	Day 1	Assessment of the sound quality with questionnaire by Gabrielsson et al.
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)

Trial Locations

Locations (1)

Hearing Research Laboratory, University Hospital Bern; 🇨🇭 Bern, Switzerland