AI-Powered Research

Patients aged 18 or older
- Seeking help for tinnitus
- Subjective tinnitus
- Tinnitus Functional Index (TFI) > 32
- Tinnitus duration > 1 and tinnitus stability > 6 months
- Hearing level (measured with a maximum of 3 months before eligibility assessment):
> Audiometry (Pure Tone Average (PTA) at 0.5,1,2,4 kHz): bilateral threshold between 50 and < 75 dB
> Hearing threshold stability (PTA < 5 dB change for 1 year in each ear)
- Becks Depression Inventory (BDI) <19
- 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 1 year 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
Difference of the Tinnitus Functional Index (TFI) between the intervention group (CI group) at 6 months after cochlear implantation (CI) and the control group at 6 months after randomization

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are to assess change in:<br>- Beck's Depression Index (BDI)<br>- Handicap Anxiety and Depression Scale (HADS)<br>- Electrocochleography (ECochG)<br>- Pure tone audiometry at 0.25, 0.5, 1, 1.5, 2; 4 kHz<br>- Speech, Spatial and Qualities of hearing scale (SSQ)<br>- EuroQoL5D<br>- Glasgow Benefit Inventory (GBI)<br>- Clinical Global Impression (CGI)<br>- Tinnitus severity Visual Analogue Scale (VAS)<br>- Tinnitus pitch and loudness matching<br>- Speech recognition test in quiet and noise<br>The usage of CI and the hearing environment on daily average will be logged from the sound processor.