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

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Dec 14, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people suffering from severe and persistent tinnitus, which is the sensation of hearing sounds that aren't actually there, like ringing or buzzing. The treatment involves an Auditory Brainstem Implant (ABI), a device designed to help restore hearing in certain patients. Interestingly, while the main purpose of the ABI is to improve hearing, many patients have reported a reduction in their tinnitus symptoms as a bonus. This trial will involve 10 patients who have been living with debilitating unilateral (one-sided) tinnitus for more than a year and have not found relief from other treatments, such as hearing aids or therapy.

To participate in this study, patients must be over 18 years old and have severe tinnitus that affects their daily life significantly. Their hearing must also meet specific criteria, with one ear having significant hearing loss and the other ear having better hearing. Participants will receive detailed information about the procedure, potential risks, and the uncertain outcomes of the ABI before agreeing to join the study. This trial is unique because it’s the first to focus specifically on using the ABI to treat tinnitus, hoping to provide a new option for those who have struggled to find effective relief.

Gender

ALL

Eligibility criteria

• 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)