Indication of Middle Ear Implant (MET) Clinical Trial
— IOM laserOfficial 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
| Verified date | July 2016 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | August 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry | The hearing will be measured by tone and speech audiometry in silence and in noise (dB) Results will be averaged per patient. | at baseline (day 0) and 8 months | |
| Secondary | Number of surgical implantation performed for the surgical laser velocimetry optimization technique | number of surgical implantations performed in the required conditions and, if necessary, deviations will be described. | at 14 months | |
| Secondary | description of adverse events throughout the study | 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. | ||
| Secondary | Middle ear transfer function measured by laser velocimetry | measured in mm/s/Pa | pre-operatively at day 0 and then at 2, 3, 8 and 14 months. | |
| Secondary | Tone and speech audiometry in silence and in noise (dB) | Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months. | ||
| Secondary | Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score | Changes will be described in both groups. GHSI questionnaire appreciate the impact of hearing loss on quality of life and whose translation is adapted to the French context. | day 0, and 2, 3, 5, 8 and 14 months. | |
| Secondary | Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score | Changes will be described in both groups. GBI questionnaire appreciate the benefit of the port of hearing aid before surgery and the benefit of the middle ear implant after the surgery. | day 0, and 2, 3, 5, 8 and 14 months. | |
| Secondary | Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score | Changes will be described in both groups. APHAB questionnaire is validated in subjects deaf to assess the discomfort associated with deafness in conditions of erveday life. | day 0, and 2, 3, 5, 8 and 14 months. | |
| Secondary | Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score | Changes will be described in both groups. SSQ questionnaire evaluate the binaural hearing. | day 0, and 2, 3, 5, 8 and 14 months. |