Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Hearing Loss, Conductive

Treatments: Device: Non-invasive bone conduction hearing aid B; Device: Non-invasive bone conduction hearing aid A

Study type: Interventional

Funder types: Other

Identifiers

NCT03129191

HRL-NIBCH

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

AB arm

Active Comparator group

Description:

Sequence: 1. Aided with non-invasive bone conduction hearing aid A 2. Aided with non-invasive bone conduction hearing aid B

Treatment:

Device: Non-invasive bone conduction hearing aid B

Device: Non-invasive bone conduction hearing aid A

BA arm

Active Comparator group

Description:

Sequence: 1. Aided with non-invasive bone conduction hearing aid B 2. Aided with non-invasive bone conduction hearing aid A

Treatment:

Device: Non-invasive bone conduction hearing aid B

Device: Non-invasive bone conduction hearing aid A