tinnitus
Conditions
Interventions
All study participants receive an ABI, which will be neurosurgically implanted.
The ABI will be switched on 6 weeks after implantation. The surgery and
post-surgery follow-up and switch-on procedure
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Unilateral tinnitus - Severely invalidating tinnitus - Men or women, age >18yr - Tinnitus that is present >1 years and was stable during the last year - Tinnitus that is nonresponsive to indicated conventional existing treatments (hearing aids and cognitive behavioral therapy. If a psychologist has indicated that CBT may ameliorate tinnitus complaints, the patient should have tried CBT for long enough time to reasonably argue that these treatments were not successful. This is the same for hearing aids. - Ipsilateral ear: pure tone audiometry (PTA) thresholds >=40dB and
Exclusion criteria
Exclusion criteria: - Psychiatric pathology and/or an unstable psychological situation as declared by a psychiatrist - Unrealistic expectations as declared by the investigator and/or psychiatrist - Life expectancy II - Pregnancy - Anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull - Anatomical abnormalities or surgical complications which might prevent placement of the ABI Active Electrode Array - If the individual is known to be intolerant of the materials used in the implant (medical grade silicone, platinum, iridium and parylene c)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is change in the Tinnitus Functioning Index (TFI). The endpoint is set at 1 year after implantation. Follow up will take place until 5 years after implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety: changes in hearing as measured by pure tone audiometry (PTA) and speech discrimination tests from baseline to follow up; changes in vestibular function as measured by vestibular tests between baseline and 3 months after initial stimulation with the ABI. • Change in TFI from 12 months to 5 years of follow up (long term effect). • Change in VAS (visual analogue scale)-scores (tinnitus loudness, tinnitus annoyance) from baseline to follow up. • Change in HADS-scores (Hospital Anxiety and Depression Scale) from baseline to follow up. • Change is THI-scores (Tinnitus Handicap Index) from baseline to follow up. • Tinnitus matching from baseline to follow up. | — |
Countries
Netherlands
Outcome results
None listed