Actively Recruiting
Assessing the Effect of the Tinnitus Implant on Loudness in Adults with Moderate to Severe Chronic Tinnitus and Hearing Loss
Led by Cochlear · Updated on 2026-06-02
16
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental Tinnitus Implant System designed for adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study aims to assess how this implant affects tinnitus loudness and annoyance and includes self-reported questionnaires about tinnitus and overall health. This device delivers electrical signals to stimulate the auditory nerve, potentially impacting tinnitus perception. The Tinnitus Implant System consists of a cochlear implant surgically placed under the skin behind the ear in the mastoid bone, with an electrode extending into the cochlea. The sound processor, worn behind the ear, powers the implant through a coil. The implant activation occurs approximately 10 weeks after surgery. Participants will be followed for at least 6 months post-activation to monitor changes. Participants will undergo tests evaluating tinnitus loudness, annoyance, and perception, as well as speech perception and hearing thresholds. Questionnaires on quality of life and health status will be completed. Researchers will also monitor for any device or procedure-related side effects. The primary outcome is the mean change in tinnitus loudness from before implantation to 6 months after activation.
CONDITIONS
Brief Title
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Normal hearing to moderately severe sensorineural hearing loss with pure tone average less than 65 dB HL in both ears
- Unilateral or asymmetric subjective tinnitus lasting at least 6 months
- Severe tinnitus loudness with VAS-L score 50-100/100 or TFI score 52-90/100
- Tinnitus not satisfactorily improved by standard care like cognitive behavioral therapy or hearing aids
- Clinically significant reduction in VAS-L score (≥ 15/100 points) after trans-tympanic promontory stimulation
- Able and willing to provide written informed consent
- Medically suitable for device use and general anesthesia
- Proficient in Dutch language
You will not qualify if you...
- Pulsatile tinnitus
- Anatomical or structural abnormalities of inner ear, cochlear nerve, or brainstem affecting response
- Medical contraindications such as brain or ear surgery, tumors, recent ear infections, otosclerosis, or major head trauma causing lasting cognitive impairment
- Medical conditions or mental illness interfering with consent or participation, including pregnancy or breastfeeding
- Clinically diagnosed depression or anxiety with high scores on screening evaluations
- Current or recent (within 2 months) use of certain medications like antidepressants or other tinnitus treatments
- Investigator site personnel or immediate family members
- Employees of Cochlear or related contractors
- Participation in another interventional clinical trial within 60 days prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical implantation of the Tinnitus Implant System device.
1 visit (in-person)
Duration - Approximately 6 months post device activation
Participants receive activation and use of the Tinnitus Implant System device to manage tinnitus symptoms.
Visits at activation (about 10 weeks after implantation), 3 months post activation, and 6 months post activation
Trial Site Locations
Total: 2 locations
1
Antwerp University Hospital (UZA)
Edegem, Belgium, Belgium, B-2650
Actively Recruiting
2
University Medical Center Utrecht
Utrecht, Netherlands, 3508
Actively Recruiting
Research Team
R
Remo Arts
K
Kelly Assouly
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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