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

Not Applicable

Completed

• Conditions: Indication of Middle Ear Implant (MET); Moderate to Severe Hearing Loss
• Interventions: Device: optimized implantation with laser velocimetry; Device: Conventional implantation

• Registration Number: NCT02845115
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Status Verified: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser velocimetry	optimized implantation with laser velocimetry	optimized implantation of laser velocimetry
control	Conventional implantation	standard care : usual technique for implanting

Primary Outcome Measures

Name	Time	Method
Change from Baseline hearing at 8 months post-implantation (hearing gain), measured by tone and speech audiometry	at baseline (day 0) and 8 months	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

Name	Time	Method
Change in the quality of life measured by SSQ (Speech Saptial Qualiteies) score	day 0, and 2, 3, 5, 8 and 14 months.	Changes will be described in both groups. SSQ questionnaire evaluate the binaural hearing.
Number of surgical implantation performed for the surgical laser velocimetry optimization technique	at 14 months	number of surgical implantations performed in the required conditions and, if necessary, deviations will be described.
Middle ear transfer function measured by laser velocimetry	pre-operatively at day 0 and then at 2, 3, 8 and 14 months.	measured in mm/s/Pa
Change in the quality of life measured by GHSI (Glasgow Health Status Inventory) score	day 0, and 2, 3, 5, 8 and 14 months.	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	day 0, and 2, 3, 5, 8 and 14 months.	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.
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.
Change in the quality of life measured by APHAB ( Abbreviated Profile of Hearing Aid Benefit) score	day 0, and 2, 3, 5, 8 and 14 months.	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.
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.