Efficacy of a Tinnitus Implant for People With Severe Tinnitus Without Damaging the Acoustic Hear… (NCT07648615) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of a Tinnitus Implant for People With Severe Tinnitus Without Damaging the Acoustic Hearing.
6 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Not responsive to the normally available clinical tinnitus treatment.
* High-frequency sensorineural hearing loss in the ear to be treated
* Hearing aid did not provide any tinnitus suppression
* Ability to use the device and follow a personalized rehabilitation program.
* Ability to undergo the surgery
Exclusion Criteria:
* 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)
* Active treatment, or treatment in the past 6 months, with either a chemotherapeutic drug for cancer, or radiation therapy to the head or neck region
* Pregnant or breastfeeding women
* Current participation in another interventional clinical study/trial in the past 30 days involving an investigational drug or device.
* Medical contra-indications to middle ear surgery, and/or anesthesia
* Cholesteatoma in the ear to be treated
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related adverse events
Timeframe: 12 months post-operatively
2
Hearing loss
Timeframe: 12months postoperatively
3
Tinnitus suppression
Timeframe: 6 months and 12 months
Trial details
NCT IDNCT07648615
SponsorENTIC research and training centre of the European Institute for ORL