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| Name | Class |
|---|---|
| CERES GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard | Experimental | Standard treatment with the ANM T30 CR®-System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANM T30 CR®-System | Device | Stimulation for 4-6h/day for a time of 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| NRS loudness and annoyance (0-100) | 0.5, 1, 2, 3, 6, 9, 12 months | |
| Tinnitus-freedom | 3,6,9,12 months | |
| Compliance |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Brinkmann, Dr. med. | HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. med. Mueller | Augsburg | 86167 | Germany | |||
| Dr. med. Jan Loehler |
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Questioning if the specified application was kept. |
| 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. | 0.5,1,2,3,6,9,12 months |
| Audiogram for hearing loss change | 3,12 months |
| TBF-12 | 3,6,9,12 months |
| Bad Bramstedt |
| 24576 |
| Germany |
| Praxisverbund Berlin | Berlin | 10119 | Germany |
| Dr. med. Daniel Osterland | Berlin | 10711 | Germany |
| Dres. med. Bodlien/Lingner/Kassuhn | Braunschweig | 38100 | Germany |
| Praxis HNO Koeln Nord | Cologne | 50735 | Germany |
| Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann | Frankfurt | 60594 | Germany |
| Dr. med. Fleissner | Freiburg im Breisgau | 79098 | Germany |
| EuromedClinic | Fürth | 90763 | Germany |
| Dr. med. Hegemann-Gaertner | Grevenbroich | 41515 | Germany |
| Dipl.-Med. Kathrin Stoelzer | Halle | 06108 | Germany |
| Dr. med. Hahbrock | Koblenz | 56068 | Germany |
| Dr. med. Wichmann | Krefeld | 47807 | Germany |
| Roemerwallklini Gmbh | Mainz | 55131 | Germany |
| HNO-Gemeinschaftspraxis im Zentrum | Mannheim | 68161 | Germany |
| Dr .med. Tatjana von Stackelberg | Meerbusch | 40667 | Germany |
| Dr. med. Ullmann | Melsungen | 34212 | Germany |
| Dr. med. Wurzer | München | 80333 | Germany |
| Dres. med. Bergmann und Davies | Nürtingen | 72622 | Germany |
| Dr. med Uwe Brinkmann | Oelde | 59302 | Germany |
| Dr. med. Huegelschaeffer | Philippsburg | 76661 | Germany |
| Dr. med. Axel Roesler | Radevormwald | 42477 | Germany |
| Dres. med. Ramming und Waller | Schweinfurt | 97421 | Germany |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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