Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06641999

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

Led by Cochlear · Updated on 2025-11-25

16

Participants Needed

2

Research Sites

41 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older.
  • Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears.
  • Best-aided phoneme recognition score of 80% or higher in both ears.
  • Unilateral or asymmetric subjective tinnitus; the worst ear must be implanted if tinnitus is asymmetric.
  • Tinnitus duration of at least 6 months.
  • Severe tinnitus loudness with VAS-L score between 50-100/100 and TFI score between 52-90/100.
  • Tinnitus that has not improved satisfactorily with standard treatments like CBT or hearing aids when indicated.
  • Clinically significant reduction (≥15/100 points) in VAS-L score in response to trans-tympanic promontory stimulation.
  • Willing and able to provide written informed consent.
  • Medically able to use the device and undergo general anesthesia for implantation.
  • Proficient in Dutch language.
Not Eligible

You will not qualify if you...

  • Pulsatile tinnitus.
  • Anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that negatively affect the intervention.
  • Medical contraindications affecting device placement or treatment, including brain or major ear surgery, tumors, recent ear infections, otosclerosis, or major head trauma causing lasting cognitive impairment.
  • Any medical condition or mental illness that may interfere with consent, cooperation, participation, or result interpretation, including pregnancy or unrealistic expectations.
  • Clinically diagnosed depression or anxiety with PHQ-9 or GAD-7 scores above 9.
  • Active use of medications for depression, anxiety, psychosis, epilepsy, or neuromodulation within two months before enrollment, except low-dose or situational use.
  • Initiating hearing aid use during the trial is not allowed; existing users may continue.
  • Investigator site personnel and immediate family members.
  • Employees of Cochlear or contractors involved in the study.
  • Participation in another interventional clinical trial involving investigational drugs or devices within 60 days prior, unless it does not impact this study.

AI-Screening

AI-Powered Screening

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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

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Research Team

R

Remo Arts

CONTACT

K

Kelly Assouly

CONTACT

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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