AI-Powered Research

• 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 <= 80 dB
o Hearing thresholds in the ear to be implanted (>= 4 kHz) >= 50 dB
o Hearing threshold stability (PTA < 5 dB change for 1 year in each ear)
• Health status allows general anesthesia and surgery for the cochlear
implantation
• Failure of regular tinnitus care (e.g. psychological or sound therapy)
• Dutch language proficiency
• Willingness and ability to participate in all scheduled procedures outlined
in the protocol
• Able to understand and sign informed consent

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome will be the difference of the tinnitus functional index (TFI)<br /><br>between the intervention (CI) at 6 months after cochlear implantation (CI) and<br /><br>the control group at 6 months after randomization.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures will be:<br /><br>- Anxiety and Depression level: BDI, HADS<br /><br>- Electrocochleography<br /><br>- Hearing level: pure tone audiometry at 0.25, 0.5, 1, 1.5, 2, 4 kHz<br /><br>- Hearing related QoL: SSQ<br /><br>- General QoL: EQ5D<br /><br>- Patient reported change: GBI and CGI<br /><br>- Tinnitus severity: VAS<br /><br>- Tinnitus pitch and loudness matching<br /><br>- Speech recognition test in quiet and noise<br /><br>The usage of CI and the hearing environment on daily average will be logged<br /><br>from the sound processor.</p><br>