Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Conductive
• Intervention / Treatment: Device: Non-invasive bone conduction hearing aid A; Device: Non-invasive bone conduction hearing aid B

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3008
    • Hearing Research Laboratory, University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AB arm; 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; The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.; Device: 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.
Active Comparator: BA arm; 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; The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.; Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Martin Kompis, Prof, University Hospital Bern, Inselsptial

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 6, 2017
• Study Completion (Actual): November 6, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Conductive
• Other Study ID Numbers: HRL-NIBCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No