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Efficacy of a Tinnitus Implant for People With Severe Tinnitus Without Damaging the Acoustic Hearing.
Sponsor: ENTIC research and training centre of the European Institute for ORL
Summary
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.
Official title: Extracochlear Electrical Stimulation in Patients With Intractable Tinnitus - a Feasibility Study
Key Details
Gender
All
Age Range
18 Years - 110 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-09-01
Completion Date
2028-09-01
Last Updated
2026-06-15
Healthy Volunteers
No
Conditions
Interventions
Extracochlear stimulation
The study will implant a cochlear implant extracochlearly, near the round window.