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Clinical Trials/NL-OMON47290
NL-OMON47290RecruitingNot Applicable

Implantation of an auditory brainstem implant for the treatment of incapacitating unilateral tinnitus - ABI for tinnitus

niversitair Medisch Centrum Groningen0 sites10 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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. 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 <=90 dB (mean over 1-2-4 kHz).
  • •- Functional hearing in the contralateral ear with PTA thresholds <=35dB with a minimal Δ25dB compared to the other (ipsilateral) ear.
  • •- Informed consent after extensive oral and written information about the surgery, complications and the uncertain effect of the ABI on tinnitus
  • •- Acceptable overall physical condition as declared by an anesthesiologist
  • •- No detectable cause for tinnitus that requires causal therapy (e.g. glomus tumor, otosclerosis, arterio-venous malformation) as investigated by medical and otological examination

Exclusion Criteria

  • •- 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 yr
  • •- 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 which might prevent placement of the ABI Active Electrode Array
  • •- If the individual is known to be intolerant of the materials used in the implant (medical grade silicone, platinum, iridium and parylene c)

Investigators

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