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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01435317

Acronym

RRL

Enrollment

200

Registered

2011-09-16

Start date

2011-11-30

Completion date

2014-07-31

Last updated

2014-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

Acoustic CR®-neuromodulation, ANM T30 CR®-System

Brief 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

Interventions

DEVICEANM T30 CR®-System

Stimulation for 4-6h/day for a time of 1 year

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Improvement of TBF-12 Score or CGI Score	12 months	Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.

Secondary

Measure	Time frame	Description
Tinnitus-freedom	3,6,9,12 months	—
Compliance	0.5,1,3,6,9,12 months	Questioning if the specified application was kept.
NRS loudness and annoyance (0-100)	0.5, 1, 2, 3, 6, 9, 12 months	—
Audiogram for hearing loss change	3,12 months	—
TBF-12	3,6,9,12 months	—
Alteration of tinnitus	0.5,1,2,3,6,9,12 months	Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026