Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.
Identification of early indicators for therapy success
Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
Representative set of safety data in a broad patient spectrum
Measurement of tinnitus burden (TBF-12 Questionnaire)
Generation of longterm compliance data
l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
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.
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