Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

Study Overview
=================
Brief Summary
-----------------
Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this gap in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

Detailed Description
-----------------
In France, up to 16 million people suffer from tinnitus or ringing in the ears daily. This parasitic sound that does not come from the patient's environment can interfere with each individual in a variable way, sometimes creating an insurmountable handicap which has not known any effective treatment validated to date. Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this gap in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

Official Title
-----------------
Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: Auditory simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old. Patient with disabling tonal tinnitus (THI score> 40) for more than 6 months. Patient with a hearing loss of at least 25dB, centered on the frequency of tinnitus and requiring hearing aids Patient who has never used a hearing aid or a tinnitus masking system. Patient who stopped all tinnitus treatment at least 1 month before the start of the study (drug treatment, psychotherapy). Patient being willing to attend all of the visits planned as part of the study. Patient affiliated or beneficiary of a social security scheme. Patient having signed the free and informed consent Exclusion Criteria: Minor patient. Patient with hyperacusis Patient already with a hearing aid or tinnitus masker. Patient undergoing psychotropic or neurotropic drug treatments. Patient with a history of psychological or psychiatric disorders. Patient with a contraindication to wearing hearing aids. Patient suffering from non-disabling tinnitus (THI score <40). Patient suffering from intermittent, non-tonal or pulsatile tinnitus. Patient participating in another clinical study. Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision. Pregnant or breastfeeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: traditional algorithm<br> | Device: Auditory simulation<br>* Each patient will be delivered each of the 2 auditory stimulation protocols considered in the context of the research: stimulation with a traditional algorithm called AT and stimulation with a notched-type algorithm called AE. The order in which will be carried out, for the same patient, each of these 2 protocols (AT then AE or AE then AT) will be randomized.<br>|
| Experimental: notched-type algorithm<br> | Device: Auditory simulation<br>* Each patient will be delivered each of the 2 auditory stimulation protocols considered in the context of the research: stimulation with a traditional algorithm called AT and stimulation with a notched-type algorithm called AE. The order in which will be carried out, for the same patient, each of these 2 protocols (AT then AE or AE then AT) will be randomized.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory | The primary endpoint is the score (out of 100 points) obtained on the Tinnitus Handicap Inventory (THI), expressed in terms of variation from the baseline. | 2 months |