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Not yet recruiting NCT07648615

Efficacy of a Tinnitus Implant for People With Severe Tinnitus Without Damaging the Acoustic Hearing.

No phase Interventional Tinnitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extracochlear stimulation.
Who it may be relevant to
Registry conditions: Tinnitus. Basic parameters: 18 years — 110 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Extracochlear Electrical Stimulation in Patients With Intractable Tinnitus - a Feasibility Study

Overview

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.

Interventions

  • Device Extracochlear stimulation
    The study will implant a cochlear implant extracochlearly, near the round window.

Primary outcome measures

  • Number of participants with treatment-related adverse events [Time frame: 12 months post-operatively]
  • Hearing loss [Time frame: 12months postoperatively]
  • Tinnitus suppression [Time frame: 6 months and 12 months]
Secondary outcome measures (1)
  • speech perception in quiet and in noise [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07648615 · TIN2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗