About this trial
This is a prospective, intervention-based, non-randomized, pre-post, single-site feasibility study that will involve data collection from individuals with intractable tinnitus. The study comprises a screening under local anesthesia and a surgery to implant the medical device. The screening will allow for accurate selection of patients. For patients not fulfilling the criteria for chronic extracochlear stimulation, the study will stop there. Patients eligible for chronic stimulation will undergo a second surgery under general anaesthesia involving the implantation of a cochlear implant with an electrode placed outside the cochlea in the vicinity of the round window. Each surgical procedure will be followed by a series of medical check-ups. Following implantation, the safety and efficiency of extracochlear chronic stimulation will be evaluated as well as the tinnitus suppression and speech perception.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Proficient in written and spoken Dutch, defined by self-report or the researcher
Intractable severe/uncompensated unilateral tinnitus, evaluated by VAS-score, and confirmed by Tinnitus functionality Index (TFI) and Tinnitus Questionnaire (TQ) (global TFI score of 54 and above and global TQ-score of 47 and above)
Suffering from tinnitus for at least a year
Disqualifiers
Chronic middle ear pathology
Surgical anatomy not allowing for implantation, evaluated by CBCT/MRI imaging
Tinnitus suppression is possible to achieve with hearing aids (as per self-report/documentation)
Clinically significant depression (HADS-score of 11 and above)
Trial design
Treatments tested in this trial
- Extracochlear stimulation
Treatment groups
Locations
Sponsors and collaborators
ENTIC research and training centre of the European Institute for ORL
Lead sponsor