Tinnitus implant: tinnitus and cochlear implantation

Rationale: Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. While the underlying aetiology of tinnitus is still debated, one hypothesis is that the tinnitus arises from changes in neural activity caused by reduced or lack of auditory input due to hearing loss which often accompanies the tinnitus. Tinnitus is a common symptom with an approximate prevalence of 10-30%, depending on the selected population. Since no curative treatment for tinnitus is available until today, symptom reduction is the highest possible effect. This study will focus on the effect of a cochlear implant (CI) to treat tinnitus.

Objective: The main objective of the study is to assess the effect of a cochlear implant on tinnitus burden in patients suffering from tinnitus accompanied by hearing loss.

Study design: 50 patients with complaints of moderate to severe tinnitus (Tinnitus Functional Index (TFI)>32 and tinnitus duration >1year) and moderate to severe hearing loss (pure tone average at 0.5,1,2,4 kHz: bilateral threshold between 50 and <75dB) will be included in this randomized controlled trial (RCT) after their Informed Consent (IC). 25 patients (CI group) shall receive a CI in the ear mostly affected by tinnitus. The other 25 patients (control group) shall follow the same follow up period of 6 months with no intervention. The follow-up sessions will take place 3 and 6 months after implantation to assess the primary outcome of tinnitus burden and secondary outcomes of quality of life, treatment related outcomes and auditory function.

Study population: The study population consists of patients seeking help for tinnitus, presenting at the outpatient clinic of ENT of the UMC Utrecht, The Netherlands. 50 patients aged 18 or older with moderate to severe tinnitus and moderate to severe hearing loss will be included after fulfilling eligibility and informed consent.

Intervention: Patients from the intervention group will be surgically implanted with a CI from Cochlear Ltd under general anesthesia on the most tinnitus affected side. A phase of rehabilitation and a phase of follow-up including auditory evaluations and questionnaires will be followed by patients from the intervention group. Patients from the control group will have no intervention and will follow the same auditory evaluations and questionnaires as the intervention group.

Significant difference between the cochlear implant recipients and the control group for tinnitus burden at 6 months post-implantation

Baseline and 3 and 6 months post-implantation (CI group)
Baseline and 3 and 6 months after randomization (control group)

Randomised:
Cochlear implantation versus no intervention