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Objective Measures in Implantable Hearing Devices

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Nicolas Verhaert, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01780025
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • auditory evoked potentials [ Time Frame: 1 - 3 - 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • speech audiometry [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mixed hearing loss

Criteria

Inclusion Criteria:

  • adults
  • mixed hearing loss

Exclusion Criteria:

  • children
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780025

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

No publications provided

Responsible Party: Nicolas Verhaert, MD, M.D., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01780025     History of Changes
Other Study ID Numbers: S53530
Study First Received: January 28, 2013
Last Updated: January 30, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013