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 Nicolas Verhaert, MD, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Enrolling by invitation

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:

Genetics Home Reference related topics: nonsyndromic hearing loss

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Nicolas Verhaert, MD, 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.

Eligibility


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

Criteria

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 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


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

Keywords provided by Nicolas Verhaert, MD, 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 September 21, 2017

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