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Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
Sponsor: University Medical Center Groningen
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2016-07
Completion Date
2028-01
Last Updated
2024-02-13
Healthy Volunteers
No
Conditions
Interventions
Auditory brainstem implant
The ABI will be implanted by the neurosurgeon. The implant is fixed in a bed drilled in the parietal-temporal cortex, and the ABI electrode array is inserted into the lateral recess of the fourth ventricle and placed on the cochlear nucleus. Access to the cochlear nucleus will be made via retrosigmoid transcranial approach.
Locations (1)
University Medical Center Groningen
Groningen, Netherlands