Chronic Tonal Tinnitus
Conditions
Brief summary
There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects. Trial objectives: * The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient. * To confirm the efficacy and safety of the coordinated reset technology. These objectives will be assessed: * By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.
Interventions
DEVICEAcoustic CR-Stimulator ANM//Technology: Acoustic coordinated reset
The CR-stimulation was originally developed by Prof. Dr. Dr. Peter Tass for deep brain stimulation (DBS). The CR-stimulation through high frequency short pulses causes a neuronal reorganization in the stimulated brain area establishing a normal neuronal activity. Based on intensive modeling studies, experimental proof of concept (POC) animal studies and a clinical POC, we proved that the pathologic activity can be recuperated to a desynchronized/healthy state with the acoustic CR-stimulation. The acoustic CR-stimulation signal will be generated by the ANM CR-Stimulator and transmitted to the ears through a speaker system
Sponsors
ANM Adaptive Neuromodulation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mentally healthy people * Chronic tonal Tinnitus * Older than 18 years * Signature of the patient informed consent * No participation in other tinnitus therapy during the clinical investigation
Exclusion criteria
* A necessity for hearing aid * Auditory hallucination * Symptomatic hearing disorders * Morbus Meniere, * Tinnitus due to temporomandibular joint disorders * Subjects who can't perceive therapeutic tones * Brainstem diseases * Psychiatric disorders * Objective Tinnitus * Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.
Countries
Germany
Outcome results
None listed