This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Implanted with Tinnitus Implant System: Active Implantable Medical Device
Antwerp University Hospital (UZA)
Edegem, Belgium, Belgium
RECRUITINGUniversity Medical Center Utrecht
Utrecht, Netherlands
RECRUITINGMean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Loudness (VAS-L) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest loudness severity
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Reported device or procedure related adverse events and harms
Number of device and procedure-related adverse events and reported harms
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in tinnitus annoyance from baseline to 6 months post activation of the Tinnitus Implant System
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Annoyance (VAS-A) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest annoyance severity
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in tinnitus perception from baseline to 6 months post activation of the Tinnitus Implant System
Self-reporting on the Tinnitus Functional Index (TFI) questionnaire
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Change in self-reported matches of tinnitus pitch and loudness to acoustic stimuli
Patient reported matching of tinnitus pitch (Hz) and loudness (dB SPL) with acoustic stimuli
Time frame: Pre-operative baseline, activation (Implant activation is approximately 10 weeks after surgical implantation of Tinnitus implant), 3 months post activation, 6 months post activation
Mean change in health-related quality of life with Tinnitus Implant System
Score of Glasgow Benefit Inventory (GBI) questionnaire
Time frame: 6 months post Tinnitus Implant System activation
Mean change in health status with Tinnitus Implant System
Score of Patient Global Impression of Change (PGIC) questionnaire
Time frame: At 6 months post Tinnitus Implant System activation
Mean change in speech perception in quiet from baseline to 6 months post-activation
Word recognition in quiet presented at 65 dB SPL in the unaided condition
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in hearing thresholds from baseline to 6 months post-activation
Bone conduction thresholds (dB HL) at any tested frequency (0.25, 0.5, 1, 1.5, 2, 4 kHz) from baseline to 6 months post-activation in the implanted ear
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
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