Here is the design of a clinical trial:

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

Included conditions:
- Tinnitus

Study Armgroups:
- {'label': 'ABI implantation', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Device: Auditory brainstem implant']}

Interventions:
- {'type': 'DEVICE', 'name': 'Auditory brainstem implant', 'description': '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.', 'armGroupLabels': ['ABI implantation'], 'otherNames': ['ABI']}

Primary Outcomes:
- {'measure': 'Tinnitus Functioning Index (TFI)', 'description': 'Unit of measure: Items on a scale.\n\nThe TFI (tinnitus functioning index) is a questionnaire validated to detect changes in tinnitus outcome after an intervention', 'timeFrame': 'pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative'}

Please estimate the sample size based on the assumption: 
No power analysis was performed.
Sample size
        This is a pilot study. Due to the experimental nature of the study, no power analysis was performed. It was empirically decided to select a cohort of 10 patients for this study.