Indication of Middle Ear Implant (MET) Clinical Trial
Official title:
Pilot Study Evaluating Surgical Optimizing of a Middle Ear Implant (MET )With Laser Velocimetry in Patients With Moderate to Severe Hearing Loss in Case of Failure of Conventional Equipment
The aging of the population, and greater exposure to noise, are responsible for an increased
incidence of hearing loss (presbycusis). This hearing loss is sensorineural disability that
has become a real public health problem. The main means of rehabilitation of this disability
is represented by the apparatus of patients with conventional hearing aids. However, these
hearing aids have several drawbacks that limit their profits, often abandoning the prosthesis
by the patient.
Middle ear implants were developed to answer these problems. They are intended to amplify the
sound signal by transmitting directly to the middle ear to compensate for the hearing loss
and are indicated in case of failure or contraindication of conventional equipment. However,
these middle ear implants currently have limitations as performance failure. Recent data show
that the performance of the ossicles repair techniques are dependent on the coupling of the
ossicular prosthesis to the ossicles. Furthermore, advances in the understanding of the
biomechanics of the ossicles confirm the importance of the placement and linkage of surgical
restoration processes. This data can be applied to middle ear implants to improve
performance. Indeed, a preliminary experimental study on anatomical parts, using analysis of
the vibration of the middle ear structures by laser velocimetry, allowed the investigators to
define the transducer placement method and coupling method to ossicles.
Investigators wish to validate in vivo results in a pilot study on a small number of patients
by comparing two surgical techniques guided by velocimetric measures.
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