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 (IOM laser)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control; standard care : usual technique for implanting	Device: Conventional implantation; 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.
Experimental: laser velocimetry; optimized implantation of laser velocimetry	Device: optimized implantation with laser velocimetry; Other Names: Group benefiting from the implantation technique optimized by laser velocimetry of a middle ear implant.( the MET ossicular stimulator 7000 the company "Otologics LLC")

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Middle Ear Implant; laser velocimetry
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 2011.679