Tinnitus Ear, Nose and Throat Tinnitus
Conditions
Interventions
Participants are randomised to one of two groups.
Intervention group: participants will trial a hearing device with built-in tinnitus sound generator feature activated for six months at home, alongsi
Sponsors
Oticon A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hearing impaired with flat or mild to moderate-severe sloping sensorineural hearing loss (SNHL). Hearing loss can be asymmetrical provided participant has been medically cleared for red flag conditions by a physician or otolaryngologist. 2. No limitation on type of fitting that can be worn (e.g. open fitting, closed dome, ear mold allowed, depending on HL). 3. New hearing instrument users preferred to eliminate pre-user bias. 4. GAD-7 anxiety screening: score from 0-9, indicating no anxiety or minimal to mild anxiety only. 5. PHQ-9 depression screening: score from 0-9, indicating no depression or minimal to mild depression only. 6. TFI questionnaire: tinnitus symptoms ranging in severity rating from =32 to =71 points. 7. Age 18 and over 8. Only mild hyperacusis symptoms
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of moderate to severe depression (score =10 in PHQ-9 screening) 2. Clinical diagnosis of moderate to severe anxiety disorder (score =10 in GAD-7 screening) 3. Patients with severe to profound hearing loss 4. Normal hearing tinnitus patients 5. Patients with very mild or severe to profound tinnitus symptoms 6. Patient where main symptom is hyperacusis 7. Patient cannot hear the sound generator signal at 82 dB(A)SPL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tinnitus Functional Index (TFI) to measure tinnitus severity 2. Tinnitus Acceptance Questionnaire (TAQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. My Tinnitus document (self-report of symptoms) 2. Hearing Handicap Inventory (HHIA/HHIE) self-report measure of hearing-related disability 3. Patient interviews at each visit | — |
Countries
United Kingdom, United States of America
Contacts
Public ContactDavid Baguley
Outcome results
None listed