Clinical Trial: Objective Measures in Implantable Hearing Devices

Study Status:
Recruit Status: Unknown status
Study Type: Observational

Official Title: Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Nicolas Verhaert, MD

Current Primary Outcome: auditory evoked potentials [ Time Frame: 1 - 3 - 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: speech audiometry [ Time Frame: 3 and 6 months ]

Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: January 28, 2013
Date Started: April 2012
Date Completion: October 2014
Last Updated: January 30, 2013
Last Verified: January 2013