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

ANM Adaptive Neuromodulation

Status and phase: Completed; Phase 4

Conditions: Tinnitus

Treatments: Device: ANM T30 CR®-System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435317

NCT2011-08-26

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• symptomatic subjective tonal chronical (> 3 months) tinnitus
• <60dB hearing loss
• men and women ≥18 years old

Main Exclusion Criteria:

• serious neurologic
• psychiatric or internistic disease
• objective tinnitus
• Morbus Menière
• craniomandibular triggered tinnitus

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

standard

Experimental group

Description:

Standard treatment with the ANM T30 CR®-System

Treatment:

Device: ANM T30 CR®-System