Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE® Method

Last updated: February 16, 2021
Sponsor: Mayfair Developments
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Hearing Loss

Hearing Impairment

Treatment

N/A

Clinical Study ID

NCT04752176
MAY001-PMCF001
  • Ages 18-85
  • All Genders

Study Summary

Tinnitus and hyperacusis are two hearing disorders that can severely impact the patient and their quality of life, as they may induce sleeping disorders, concentration troubles, social life disturbances. Mayfair Developments has created and developed the innovating ØREBLUE® method in order to relieve, possibly completely, tinnitus and hyperacusis symptoms. The ØREBLUE® method relies on a medical device, CE marked, that consists of an auditory stimulation box associated with five softwares. This medical device diffuses thanks to a headphone a specific and personalized sound therapy treatment for the patient. This retrospective, observational study aims at collecting data about the ØREBLUE® method used in routine care and describing its efficacy on tinnitus and hyperacusis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 85 years old
  • Subject seen in consultation in the investigational site from CE marking up to 2 yearsthereafter,
  • Sufficient ENT investigations,
  • Satisfactory general condition: non-invalidating medical history (ENT disorders andothers),
  • The subject agrees to work on the emotional part linked to their condition,
  • Permanent and disabling tinnitus and/or hyperacusis, with the followingcharacteristics for tinnitus: subjective, chronic (present for more than 1 year),resistant to usual treatments (medication, hearing aid with or without masking,psychotherapy) continued for a minimum of 6 months, severe tinnitus, disablingtinnitus (measurement with numerical scale score and THI questionnaire),
  • Patient informed about the study and has no objection to take part

Exclusion

Exclusion Criteria:

  • Proven presence of an anxiety disorder of claustrophobia type,
  • History of neurological disease, in particular personal or family history of epilepsyor seizure (infantile hyperthermic convulsions, or other type of seizure),
  • Serious psychiatric history or attempted autolysis, concomitant use of antidepressantand neuroleptic treatment,
  • Bilateral cophosis,
  • Medication monitoring that can generate more or less tinnitus,
  • More than 6 months since the end of the last treatment or therapy against tinnitus,
  • For women: possibility of pregnancy (absence of effective contraception or certainmenopause), breastfeeding woman,
  • Context of medico-legal litigation and / or concomitant participation in anotherprotocol.

Study Design

Total Participants: 40
Study Start date:
March 22, 2019
Estimated Completion Date:
January 31, 2023

Study Description

Tinnitus is a clinical symptom indicative of abnormal stimulation of the auditory system characterized by the perception of chronic sound in the absence of an external sound source and that only the affected subject perceives intrusively.Its presence can occur independently unilaterally, bilaterally, or be described as perceived in the center of the head and can be heard continuously or intermittently at varying levels of intensity and frequency. There are two types of tinnitus depending on whether it can be detected with a stethoscope by the doctor (objective tinnitus) or only heard by the subject (subjective tinnitus). Many consequences, such as anxiety, depression and sleep disorders, linked to suffering from tinnitus will impact daily life in different forms.

Both types of tinnitus may be accompanied by a higher intolerance to noise which is called hyperacusis.Hyperacusis is defined as an intolerance (and not a finer sensitivity to sounds) to environmental sound levels, the intensity of which, of varying intensity, represents neither risk nor inconvenience for people with normal hearing, but which induces discomfort or pain in people with hyperacusis.

In these clinical situations, the ØREBLUE® method is an innovative treatment with the objective of eliminating the symptoms of tinnitus and hyperacusis depending on the group to which the subject belongs. Its innovative character is based on the design of a sound signal processing device, CE marked as medical device, developed by Mayfair Developments. This technological innovation has been developed to respond specifically to the hearing profile of each subject and to provide personalized rehabilitation of their hearing sphere.

Connect with a study center

  • Hearing Institute of Resources

    La Rochelle,
    France

    Active - Recruiting

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