An interventional study of Extracochlear stimulation in Tinnitus, sponsored by ENTIC research and training centre of the European Institute for ORL. Not yet recruiting. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by ENTIC research and training centre of the European Institute for ORL · Not applicable, Interventional, and Treatment
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.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 6 is below the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →This is the only study on the registry with ENTIC research and training centre of the European Institute for ORL as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implanted extracochlearly with a cochlear implant - active implantable medical device.
Device: Extracochlear stimulation
The study will implant a cochlear implant extracochlearly, near the round window.
Number of participants with treatment-related adverse events
The primary objective of this clinical feasibility study is to evaluate safety of the cochlear implant system when implanted extracochlear, near the round window. The number of adverse events in each participant will be reported.
Time frame: 12 months post-operatively
Hearing loss
The primary objective of this clinical feasibility study is to evaluate safety, and usability of the cochlear implant system when implanted extracochlear, near the round window. This includes no major deterioration of hearing thresholds. Hearing thresholds will be measured by pure tone audiometry.
Time frame: 12months postoperatively
Tinnitus suppression
Demonstrate the efficiency of extracochlear electrical stimulation for tinnitus suppression after 6 and 12 months after chronic extracochlear electrical stimulation.The change in self-reported tinnitus severity after 12 months of chronic extracochlear electrical stimulation evaluated with the VAS-scores for tinnitus intensity and annoyance, and the TQ and TFI questionnaires.
Time frame: 6 months and 12 months
speech perception in quiet and in noise
Evaluate the effect on speech perception and sound quality of extracochlear electrical stimulation in the region of the round window at 12 months after implantation of the device.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 24 months is above that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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