Objective Measures in Implantable Hearing Devices

Completed

• Conditions: Mixed Hearing Loss
• Interventions: Behavioral: Auditory evoked potentials and audiometry; Behavioral: Auditory evoked potentials

• Registration Number: NCT01780025
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2013-01
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• adults
• mixed hearing loss

Exclusion Criteria

• children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mixed hearing loss	Auditory evoked potentials	-
Mixed hearing loss	Auditory evoked potentials and audiometry	-

Primary Outcome Measures

Name	Time	Method
auditory evoked potentials	1 - 3 - 6 months

Secondary Outcome Measures

Name	Time	Method
speech audiometry	3 and 6 months

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium