NCT03129191

Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hearing Loss, Conductive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-11-06
• Completion: 2017-11-06
• First posted: 2017-04-26
• Last updated: 2017-11-08

Locations

1 site across 1 country: Switzerland