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 (IOM laser)

Civil Hospices of Lyon

Status

Completed

Conditions

Indication of Middle Ear Implant (MET)

Moderate to Severe Hearing Loss

Treatments

Device: Conventional implantation

Device: optimized implantation with laser velocimetry

Study type

Interventional

Funder types

Other

Identifiers

NCT02845115

2011.679

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 to 60 years;
Having given written informed consent prior to any procedure related to the study;
Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
Indication and IOM implantation request by the patient with a patient physically, psychologically and legally able to ask its implementation
Average deafness to severe (mean thresholds between 40 to 90 dB) with speech discrimination> 40% to 75 dB.
Deafness of pure perception or mixed hearing loss
Non-fluctuating deafness over the last two years
Failed or cons-indication to conventional equipment
Rocky Scanner and MRI normal brain
Patient fluent in French (to ensure validity audiological measures

Exclusion criteria

Pregnant women or likely to be during the study.
Not affiliated with a social security scheme Patients
Major Patients protected by provisions of the law (Public Health Code).
Refusal of consent.
Ongoing Participation in another study that may interfere with the proposed study (investigator assessment).
Existence of a cons-indication for surgery or port of the implant
Motivation only aesthetic, evaluated by the principal investigator.
Inability of predictable medium-term monitoring.
Acoustic neuroma, tumors and other evolutionary processes of the rock and the cerebellopontine angle.
Pathology requiring follow-up MRI (IOM against-indicating MRI).
Patient with against-indication to MRI.
Contraindication to the establishment of a pacemaker ossicular MET