Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus

Recruiting now · Not applicable

Conditions studied: Tinnitus

In brief

Tinnitus is the perception of sound or noise in the absence of an external physical source. It is a highly prevalent condition and for a high percentage of patients, there is no satisfying treatment modality. For some people, tinnitus has a very severe impact on quality of life, leading to incapacity for work and sometimes even suicidality. The auditory brainstem implant (ABI) is an implant indicated for the restoration of hearing in patients with an hypo-, or aplasia of the cochlear nerve or with dysfunction of the nerve caused by tumor growth in neurofibromatosis type II. It has been shown that the standard intended effect of an ABI has reduction of tinnitus as a welcome side effect in about 66% of the cases. This is in analogy with the promising effect of a cochlear implant (CI) as a treatment for patients with unilateral tinnitus. In this study, the effect of an ABI on severely invalidating, unilateral, intractable tinnitus will be investigated. The ABI may have an advantage over the CI as tinnitus treatment, because CI-implantation leads to destruction of inner ear structures, leading to profound deafness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI for the primary aim of tinnitus reduction in an intervention pilot study. In total 10 patients with unilateral, intractable tinnitus and severe hearing loss in the ipsilateral ear, will be implanted with the ABI.

Key facts

Study ID

NCT02630589

Run by

University Medical Center Groningen

People needed

10

Starts

2016-07-01

Expected to finish

2028-01-01

Last updated by the study team

2024-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• University Medical Center Groningen — Groningen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.