Implantation of an auditory brainstem implant for the treatment of incapacitating unilateral tinnitus

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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 <=90 dB (mean over 1-2-4 kHz).
- Functional hearing in the contralateral ear with PTA thresholds <=35dB with a minimal Δ25dB compared to the other (ipsilateral) ear.
- Informed consent after extensive oral and written information about the surgery, complications and the uncertain effect of the ABI on tinnitus
- Acceptable overall physical condition as declared by an anesthesiologist
- No detectable cause for tinnitus that requires causal therapy (e.g. glomus tumor, otosclerosis, arterio-venous malformation) as investigated by medical and otological examination

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 <5 yr
- History of blood coagulation pathology
- ASA >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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is change in the Tinnitus Functioning Index (TFI). The<br /><br>endpoint is set at 1 year after implantation. Follow up will take place until 5<br /><br>years after implantation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Safety: changes in hearing as measured by pure tone audiometry (PTA) and<br /><br>speech discrimination tests from baseline to follow up; changes in vestibular<br /><br>function as measured by vestibular tests between baseline and 3 months after<br /><br>initial stimulation with the ABI.<br /><br>• Change in TFI from 12 months to 5 years of follow up (long term effect).<br /><br>• Change in VAS (visual analogue scale)-scores (tinnitus loudness, tinnitus<br /><br>annoyance) from baseline to follow up.<br /><br>• Change in HADS-scores (Hospital Anxiety and Depression Scale) from baseline<br /><br>to follow up.<br /><br>• Change is THI-scores (Tinnitus Handicap Index) from baseline to follow up.<br /><br>• Tinnitus matching from baseline to follow up.</p><br>