Objective Measures in Implantable Hearing Devices

Overview

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.

Full Title of Study: “Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2020

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.

Interventions

  • Behavioral: Auditory evoked potentials and audiometry
  • Behavioral: Auditory evoked potentials
    • Different protocols for audiometry and auditory evoked potentials

Arms, Groups and Cohorts

  • Mixed hearing loss

Clinical Trial Outcome Measures

Primary Measures

  • auditory evoked potentials
    • Time Frame: 1 – 3 – 6 months

Secondary Measures

  • speech audiometry
    • Time Frame: 3 and 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • adults – mixed hearing loss Exclusion Criteria:

  • children

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Collaborator
    • Fund for Scientific Research, Flanders, Belgium
  • Provider of Information About this Clinical Study
    • Sponsor

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