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Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.
The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.
A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
UZ Leuven
Leuven, Belgium
Start Date
April 1, 2012
Primary Completion Date
November 1, 2020
Completion Date
November 1, 2020
Last Updated
January 27, 2023
15
ACTUAL participants
Auditory evoked potentials and audiometry
BEHAVIORAL
Auditory evoked potentials
BEHAVIORAL
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Data Source & Attribution
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