Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01780025 |
| Other study ID # |
S53530 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2012 |
| Est. completion date |
November 2020 |
Study information
| Verified date |
January 2013 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
