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

Study acronym: TINIS
StatusRecruiting
PhaseNot applicable
SponsorCochlear
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Apr 2026 to Jul 2027v4
  2. Minor Start date changed from estimate of May 2025 to Jun 16, 2025
    • Site details revised at 1 of 2 sites
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2025 to May 2025
    • Site details revised at 2 of 2 sites
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
28 trials monitored
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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.
Trial Details
NCT Number NCT06641999
Lead Sponsor Cochlear
Conditions
(from sponsor)
Tinnitus, Hearing Loss, Bilateral or Unilateral, Normal Hearing
Related terms Hearing Loss, Tinnitus
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov