Clinical trial NCT02845115: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate to Severe Hearing Loss
Indication of Middle Ear Implant (MET)
Keywords: Middle Ear Implant
laser velocimetry
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
timeFrame: at baseline (day 0) and 8 months
Secondary outcomes:
measure: Number of surgical implantation performed for the surgical laser velocimetry optimization technique
timeFrame: at 14 months
measure: description of adverse events throughout the study
timeFrame: pre and post-operatively at day 0, at day 4, day 8 and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
measure: Middle ear transfer function measured by laser velocimetry
timeFrame: pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
measure: Tone and speech audiometry in silence and in noise (dB)
timeFrame: Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
measure: Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score
timeFrame: day 0, and 2, 3, 5, 8 and 14 months.
measure: Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score
timeFrame: day 0, and 2, 3, 5, 8 and 14 months.
measure: Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score
timeFrame: day 0, and 2, 3, 5, 8 and 14 months.
measure: Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score
timeFrame: day 0, and 2, 3, 5, 8 and 14 months.
Other outcomes:
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