An interventional study of Conventional implantation and optimized implantation with laser velocimetry in Moderate to Severe Hearing Loss and Indication of Middle Ear Implant (MET), sponsored by Hospices Civils de Lyon. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
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Exclusion Criteria:
standard care : usual technique for implanting
Device: Conventional implantation
optimized implantation of laser velocimetry
Device: optimized implantation with laser velocimetry
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.
Also known as: Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC")
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.
Time frame: at baseline (day 0) and 8 months
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.
Time frame: at 14 months
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.
Middle ear transfer function measured by laser velocimetry
measured in mm/s/Pa
Time frame: pre-operatively at day 0 and then at 2, 3, 8 and 14 months.
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.
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.
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
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.
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
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.
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
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.
Time frame: day 0, and 2, 3, 5, 8 and 14 months.
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon