moderate to severe tinnitus
Conditions
Interventions
Patients from the intervention group will be surgically implanted with a CI
from Cochlear Ltd under general anesthesia on the most tinnitus affected side.
A phase of rehabilitation and a phase of fo
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients aged 18 or older • Seeking help for tinnitus • Subjective tinnitus • Tinnitus Functional Index (TFI) > 32 • Tinnitus duration > 1 year and subjective tinnitus stability > 6 months • Hearing level: o Audiometry (Pure Tone Average (PTA) at 0.5,1,2 kHz): bilateral threshold >= 40 and = 4 kHz) >= 50 dB o Hearing threshold stability (PTA
Exclusion criteria
Exclusion criteria: • Patient primary seeking help for non-tinnitus hearing problems • Abnormal cochlear anatomy(i.e. ossification) • Comorbidity with an expected survival of less than five years based on medical history as assessed by clinician and in electronical patient file • Additional handicaps that would prevent participation in the evaluations • Presence of any instable psychiatric condition within 6 months before start of the study • Patient with active clinical depression within the 6 months before start of the study • Unrealistic expectations on the part of the patient regarding the possible benefits, risks and limitations that are inherent to the procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome will be the difference of the tinnitus functional index (TFI) between the intervention (CI) at 6 months after cochlear implantation (CI) and the control group at 6 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be: - Anxiety and Depression level: BDI, HADS - Electrocochleography - Hearing level: pure tone audiometry at 0.25, 0.5, 1, 1.5, 2, 4 kHz - Hearing related QoL: SSQ - General QoL: EQ5D - Patient reported change: GBI and CGI - Tinnitus severity: VAS - Tinnitus pitch and loudness matching - Speech recognition test in quiet and noise The usage of CI and the hearing environment on daily average will be logged from the sound processor. | — |
Countries
Netherlands
Outcome results
None listed