Implantation of an Auditory Brainstem Implant for Unilateral Tinnitus Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of an auditory brainstem implant (ABI) to treat patients suffering from severely invalidating unilateral tinnitus. The ABI is designed to restore hearing in individuals with dysfunction of the cochlear nerve and has shown a side effect of tinnitus reduction in previous cases. The study aims to evaluate the efficacy and safety of the ABI specifically for tinnitus suppression, as this is the first time it is being used primarily for this purpose. Participants will undergo the implantation procedure and be monitored for outcomes related to their tinnitus symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Unilateral tinnitus
* Severely invalidating tinnitus
* Men or women, age \>18yr
* Tinnitus that is present \>1 years and was stable during the last year
* Tinnitus that is nonresponsive to indicated conventional existing treatments (hearing aids and cognitive behavioral therapy (CBT)). If a psychologist has indicated that CBT may ameliorate tinnitus complaints, the patient should have tried CBT for long enough time to reasonably argue that these treatments were not successful. This is the same for hearing aids.
* Ipsilateral ear: pure tone audiometry (PTA) thresholds \>40dB and \<90dB (mean over 1-2-4kHz)
* Functional hearing in the contralateral ear with pure tone audiometry thresholds \<35dB (mean over 1-2-4 kHz) and with a minimum Δ25dB compared to the ipsilateral ear.
* Informed consent after extensive oral and written information about the surgery, complications and the uncertain effect of the ABI on tinnitus

Exclusion Criteria:

* Detectable cause for tinnitus that requires causal therapy (e.g. vestibular schwannoma, glomus tumor, otosclerosis, arteriovenous malformation) as investigated by radiological and otological examination
* Psychiatric pathology and/or an unstable psychological situation as declared by a psychiatrist
* Unrealistic expectations as declared by the investigator and/or psychiatrist
* Life expectancy \<5 years
* History of blood coagulation pathology
* ASA \>II
* Pregnancy
* Anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull
* Anatomical abnormalities or surgical complications that might prevent placement of the Auditory Brainstem Implant Active Electrode Array
* Known intolerance to the materials used in the implant (medical grade silicone, platinum, iridium and parylene C)

Where it's running

• University Medical Center Groningen
  Groningen, Netherlands Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DeepTMS for chronic tinnitus using different H-coils

  This study tests whether deep repetitive transcranial magnetic stimulation with different H-coils can reduce tinnitus distress in adults with chronic tinnitus, compared to placebo.

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• Non-Invasive Neurofeedback for Tinnitus Distress

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• TRTL-913 in adults with tinnitus: safety and signals of benefit

  This trial tests TRTL-913 versus placebo in healthy adults and in adults with tinnitus to see if it is safe, tolerable, and potentially helpful for tinnitus patients.

  Recruiting Phase 2 Tortugas Neuroscience, Inc. · Newcastle, New South Wales and 9 other locations · NCT07777549

• Foot reflexology or ta-VNS for tinnitus in adults

  This trial tests whether foot reflexology, left-ear vagus nerve stimulation, or auricular acupressure can help reduce tinnitus symptoms in adults with tinnitus.

  Recruiting Tzu Chi University · Hualien City · NCT07711639

• Mild 8 dB hearing amplification for tinnitus in adults with normal hearing

  This test tries wearing hearing aids that add a small (8 dB) boost to see if they reduce tinnitus symptoms in adults with normal hearing.

  Recruiting Technical University of Denmark · Lyngby · NCT07489807

• Neck nerve electrical stimulation combined with sound-frequency training for chronic tonal tinnitus

  This trial tests whether pairing a safe electrical stimulation of the greater occipital nerve with an active sound-frequency training task can reduce tinnitus loudness and distress in adults with chronic tonal tinnitus.

  Recruiting University of Dublin, Trinity College · Dublin, Dublin · NCT07393880

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.