Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Objective Measures in Implantable Hearing Devices

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Enrolling by invitation
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Nicolas Verhaert, MD, Universitaire Ziekenhuizen Leuven Identifier:
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
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.

Condition Intervention
Mixed Hearing Loss
Behavioral: Auditory evoked potentials and audiometry
Behavioral: Auditory evoked potentials

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

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

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

Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mixed hearing loss Behavioral: Auditory evoked potentials and audiometry Behavioral: Auditory evoked potentials
Different protocols for audiometry and auditory evoked potentials

Detailed 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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mixed hearing loss

Inclusion Criteria:

  • adults
  • mixed hearing loss

Exclusion Criteria:

  • children
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01780025

UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Nicolas Verhaert, MD
Fund for Scientific Research, Flanders, Belgium
  More Information

Responsible Party: Nicolas Verhaert, MD, M.D., Universitaire Ziekenhuizen Leuven Identifier: NCT01780025     History of Changes
Other Study ID Numbers: S53530
Study First Received: January 28, 2013
Last Updated: January 30, 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:
Coupling to the inner ear

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 25, 2017