Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

Not Applicable

• Conditions: Tinnitus
• Interventions: Device: Auditory simulation

• Registration Number: NCT04807686
• Lead Sponsor: Ramsay Générale de Santé

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.

Study Timeline

• Study Start: 2019-07-19
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
notched-type algorithm	Auditory simulation	-
traditional algorithm	Auditory simulation	-

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory	2 months	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.

Trial Locations

Locations (1)

Hôpital Privé Clairval; 🇫🇷 Marseille, France