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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Time Frame
Start Date: 2016-07
Estimated Completion Date: 2028-01
Participants
Target number of participants: 10
Treatments
Experimental: ABI implantation
All 10 patients included in the study will be neurosurgically implanted with the ABI. This is open label, not blinded. The implant is permanent, but can be switched off.
Sponsors
Collaborators: MED-EL Elektromedizinische Geräte GesmbH
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov