Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Hearing Loss, Conductive Clinical Trial

Official title:

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129191
• Other study ID #: HRL-NIBCH
• Status: Completed
• Phase: N/A
• First received: April 19, 2017
• Last updated: November 6, 2017
• Start date: July 1, 2017
• Est. completion date: November 6, 2017

Study information

• Verified date: November 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Conductive

Intervention

Device:
• Non-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.
• Non-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.

Locations

Country	Name	City	State
Switzerland	Hearing Research Laboratory, University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Sound localization	Mean absolute localization error (in degrees)	Day 1
Secondary	Subjective evaluation of the sound quality	Assessment of the sound quality with questionnaire by Gabrielsson et al.	Day 1