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Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life") — RRL  

Tinnitus Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01435317
Study type Interventional
Source ANM Adaptive Neuromodulation GmbH
Contact
Status Completed
Phase Phase 4
Start date November 2011
Completion date July 2014
View Details
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