Normal hearing persons with tinnitus symptoms Ear, Nose and Throat Tinnitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal hearing or hearing loss not more than 25 dB between 250 Hz and 2 kHz 2. Minimum 6 months tinnitus (no upper limit) 3. Category 1 (Jastreboff & Hazell, 2004) patients with normal hearing and severe tinnitus 4. Age 18-75 years 5. Inclusion of mono or bilateral tinnitus and with moderate hyperacusis (up to 6 in VAS scale), exclusion of pathological severe anxiety and depression (THI >= 80)
Exclusion criteria
Exclusion criteria: All tinnitus aetiology excluding: Meniere, middle-external ear desease, somatosensory tinnitus under physical therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Demonstrate that the Oticon device is at least as effective as other combination/sound generator devices that are used currently 2. Demonstrate that the Oticon device is more effective than other combination/sound generator devices that are used currently In other words, to understand what makes the Ti different (better?) in comparison with other devices. | — |
Secondary
| Measure | Time frame |
|---|---|
| New sounds: red or pink noise, modulated sounds, and/or ocean sounds are appreciated and preferred by patients | — |
Countries
Italy