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| Name | Class |
|---|---|
| Competence Center for Medical Devices GmbH | UNKNOWN |
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The main objective of this clinical trial is to evaluate the effectiveness and safety of the medical product ForgTin with regard to the impairment and change in the sensation of tinnitus (volume, frequency, psychological stress).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ForgTin | Experimental | Patients randomized into group 1 will receive the ForgTin Medical Device for a duration of 3 months. |
|
| No intervention | No Intervention | Patients randomized into group 2 will receive no device for a duration of 3 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ForgTin© | Device | The device is clamped behind the ear via two connected temple parts that pressed together around the connecting axis until an individual perfect wearing comfort is achieved. The pressure is adjusted so that the wearing of ForgTin© is barely noticed at all and may be changed at any time. The aim is a slight pressure stimulation of clearly defined points behind the ear - thus wearing ForgTin© leads to a minimization of individual tinnitus noises. |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Handicap Inventory | Tinnitus Impairment as assessed by the Tinnitus Handicap Inventory (THI) | Change of the Tinnitus Handicap Inventory assessed at Day 0, Month 3, Month 4, Month 7 |
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Inclusion Criteria:
Male and female patients (aged > 18 years)
Subjective tinnitus in one or both ears with intermittent or continuous symptoms with a duration of > 6 months
Tinnitus of Grade II, III or IV according to Mini-Tinnitus-Questionnaire (Mini-TF12):
If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
Provides written informed consent
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Patients will be randomized into two groups whereas both groups will experience the therapy during the course of the clinical investigation.
Group 1 receives the intervention for a duration of three months. This Phase I is followed by a Washout period of one month and by a non-interventional phase (Phase II).
Group 2 receives no initial treatment for a duration of three months (Phase I). This Phase I is followed by a Washout period of one month and by an interventional phase (Phase II). Phase III is introduced for both groups for ethical and motivational purposes and to observe potential long-term effects within Group 2.
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|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |