Back to results

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Primary Purpose

Hearing Loss, Conductive

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Non-invasive bone conduction hearing aid A

Non-invasive bone conduction hearing aid B

About this trial

This is an interventional treatment trial for Hearing Loss, Conductive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Hearing Research Laboratory, University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

AB arm

BA arm

Arm Description

Sequence: Aided with non-invasive bone conduction hearing aid A Aided with non-invasive bone conduction hearing aid B

Sequence: Aided with non-invasive bone conduction hearing aid B Aided with non-invasive bone conduction hearing aid A

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Sound localization

Mean absolute localization error (in degrees)

Subjective evaluation of the sound quality

Assessment of the sound quality with questionnaire by Gabrielsson et al.

Full Information

NCT ID

NCT03129191

First Posted

April 19, 2017

Last Updated

November 6, 2017

Sponsor

Insel Gruppe AG, University Hospital Bern

1. Study Identification

Unique Protocol Identification Number

NCT03129191

Brief Title

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Official Title

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

November 6, 2017 (Actual)

Study Completion Date

November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Conductive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AB arm

Arm Type

Active Comparator

Arm Description

Sequence: Aided with non-invasive bone conduction hearing aid A Aided with non-invasive bone conduction hearing aid B

Arm Title

BA arm

Arm Type

Active Comparator

Arm Description

Sequence: Aided with non-invasive bone conduction hearing aid B Aided with non-invasive bone conduction hearing aid A

Intervention Type

Device

Intervention Name(s)

Non-invasive bone conduction hearing aid A

Intervention Description

The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.

Intervention Type

Device

Intervention Name(s)

Non-invasive bone conduction hearing aid B

Intervention Description

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.

Primary Outcome Measure Information:

Title

Speech reception threshold in noise (S0NDIFF)

Description

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.

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Speech reception threshold in noise (S90NDIFF)

Description

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.

Time Frame

Day 1

Title

Speech reception threshold in noise (S270NDIFF)

Description

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.

Time Frame

Day 1

Title

Sound localization

Description

Mean absolute localization error (in degrees)

Time Frame

Day 1

Title

Subjective evaluation of the sound quality

Description

Assessment of the sound quality with questionnaire by Gabrielsson et al.

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Kompis, Prof

Organizational Affiliation

University Hospital Bern, Inselsptial

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hearing Research Laboratory, University Hospital Bern

City

Bern

ZIP/Postal Code

3008

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

We'll reach out to this number within 24 hrs