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Objective Measures in Implantable Hearing Devices

Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01780025
Enrollment
15
Registered
2013-01-30
Start date
2012-04-30
Completion date
2020-11-30
Last updated
2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed Hearing Loss

Keywords

Hearing, Thresholds, Coupling to the inner ear

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.

Interventions

BEHAVIORALAuditory evoked potentials and audiometry

Different protocols for audiometry and auditory evoked potentials

Sponsors

Fund for Scientific Research, Flanders, Belgium
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* adults * mixed hearing loss

Exclusion criteria

* children

Design outcomes

Primary

MeasureTime frame
auditory evoked potentials1 - 3 - 6 months

Secondary

MeasureTime frame
speech audiometry3 and 6 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026