Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752176
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2021-02-03
Brief Title:
Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE Method
Sponsor:
Mayfair Developments
Organization:
Mayfair Developments
Study Overview
Official Title:
Evaluation of the Elimination of Tinnitus and Hyperacusis by the ØREBLUE Method
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 intrusivelyIts 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 hyperacusisHyperacusis 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
Both types of tinnitus may be accompanied by a higher intolerance to noise which is called hyperacusisHyperacusis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None