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Objective Measures in Implantable Hearing Devices

U

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Mixed Hearing Loss

Treatments

Behavioral: Auditory evoked potentials
Behavioral: Auditory evoked potentials and audiometry

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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 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.

Enrollment

15 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adults
  • mixed hearing loss

Exclusion criteria

  • children

Trial design

15 participants in 1 patient group

Mixed hearing loss
Treatment:
Behavioral: Auditory evoked potentials
Behavioral: Auditory evoked potentials and audiometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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