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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Stimulation for 4-6h/day for a time of 1 year
Dr. med. Mueller
Augsburg, Germany
Dr. med. Jan Loehler
Bad Bramstedt, Germany
Praxisverbund Berlin
Berlin, Germany
Dr. med. Daniel Osterland
Berlin, Germany
Dres. med. Bodlien/Lingner/Kassuhn
Braunschweig, Germany
Praxis HNO Koeln Nord
Cologne, Germany
Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
Frankfurt, Germany
Dr. med. Fleissner
Freiburg im Breisgau, Germany
EuromedClinic
Fürth, Germany
Dr. med. Hegemann-Gaertner
Grevenbroich, Germany
...and 13 more locations
Improvement of TBF-12 Score or CGI Score
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
Time frame: 12 months
NRS loudness and annoyance (0-100)
Time frame: 0.5, 1, 2, 3, 6, 9, 12 months
Tinnitus-freedom
Time frame: 3,6,9,12 months
Compliance
Questioning if the specified application was kept.
Time frame: 0.5,1,3,6,9,12 months
Alteration of tinnitus
Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.
Time frame: 0.5,1,2,3,6,9,12 months
Audiogram for hearing loss change
Time frame: 3,12 months
TBF-12
Time frame: 3,6,9,12 months
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