Back to resultsSurgical 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)
Primary Purpose
Moderate to Severe Hearing Loss, Indication of Middle Ear Implant (MET)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional implantation
optimized implantation with laser velocimetry
Sponsored by
About this trial
This is an interventional other trial for Moderate to Severe Hearing Loss focused on measuring Middle Ear Implant, laser velocimetry
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
control
laser velocimetry
Arm Description
standard care : usual technique for implanting
optimized implantation of laser velocimetry
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
description of adverse events throughout the study
Middle ear transfer function measured by laser velocimetry
measured in mm/s/Pa
Tone and speech audiometry in silence and in noise (dB)
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02845115
Brief Title
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
Acronym
IOM laser
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Hearing Loss, Indication of Middle Ear Implant (MET)
Keywords
Middle Ear Implant, laser velocimetry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Other
Arm Description
standard care : usual technique for implanting
Arm Title
laser velocimetry
Arm Type
Experimental
Arm Description
optimized implantation of laser velocimetry
Intervention Type
Device
Intervention Name(s)
Conventional implantation
Intervention Description
Usual implantation technique of a middle ear implant. The principle of the ossicular stimulator middle ear transducer MET 7000 (Middle Ear Transducer, METTM) is to directly transmit sounds on the ossicles bypassing the outer ear. Their constraint is the surgical placement of the implant.
MET 7000 system (OTOLOGICS LLC, USA) is the implant that the investigators will use for their patients. The stimulator is usually placed against the body of the anvil by simple contact in the case of sensorineural hearing loss. In the case of mixed hearing loss, the stimulator will come in contact with the bracket using a titanium clip (ossicular prosthesis used in otologic surgery for ossiculoplasties). The optimized version corresponds to the use of the conventionally used in mixed deafness and applied to neurosensory deafness art. It is screwed onto the mastoid bone, the motor is suspended in the mastoid cavity and transmits vibrations to the body of the anvil by simple contact of the transducer.
Intervention Type
Device
Intervention Name(s)
optimized implantation with laser velocimetry
Other Intervention Name(s)
Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC")
Primary Outcome Measure Information:
Title
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry
Description
The hearing will be measured by tone and speech audiometry in silence and in noise (dB) Results will be averaged per patient.
Time Frame
at baseline (day 0) and 8 months
Secondary Outcome Measure Information:
Title
Number of surgical implantation performed for the surgical laser velocimetry optimization technique
Description
number of surgical implantations performed in the required conditions and, if necessary, deviations will be described.
Time Frame
at 14 months
Title
description of adverse events throughout the study
Time Frame
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.
Title
Middle ear transfer function measured by laser velocimetry
Description
measured in mm/s/Pa
Time Frame
pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
Title
Tone and speech audiometry in silence and in noise (dB)
Time Frame
Baseline at inclusion visit, day 0, and then at 2, 3, 4, 5, 6, 7, 8 and 14 months.
Title
Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score
Description
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.
Time Frame
day 0, and 2, 3, 5, 8 and 14 months.
Title
Change in the quality of life measured by GBI (Glasgow Benefit Inventory) score
Description
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.
Time Frame
day 0, and 2, 3, 5, 8 and 14 months.
Title
Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score
Description
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.
Time Frame
day 0, and 2, 3, 5, 8 and 14 months.
Title
Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score
Description
Changes will be described in both groups. SSQ questionnaire evaluate the binaural hearing.
Time Frame
day 0, and 2, 3, 5, 8 and 14 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs