N/A
N=22
Cochlear Promontory Stimulation for Treatment of Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT03759834 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory — -31 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cochlear promontory stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory |
-31 | — |
| SECONDARY Optimal Location of Tinnitus Relief |
— | — |
| SECONDARY Auditory Feedback |
22 | — |
| SECONDARY Tactile Feedback |
22 | — |
| SECONDARY Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index |
-35 | — |
| SECONDARY Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale |
-3.7 | — |
Summary
Tinnitus is the perception of sound when no external noise is present. The Center for Disease Control (CDC) estimates over 50 million - nearly 15% of the general public -experience some form of tinnitus. Roughly 20 million people struggle with burdensome chronic tinnitus, with 2 million experiencing extreme and debilitating symptoms.
The 2014 Clinical Practice Guideline on tinnitus from the American Academy of Otolaryngology - Head and Neck Surgery summarized the existing state of tinnitus management by stating "A cure for primary tinnitus does not yet exist, and despite claims to the contrary, no method has been proven to provide long-term suppression of tinnitus."
The purpose of this study is to look at the safety and efficacy of cochlear promontory stimulation in the short term relief of tinnitus. The secondary goal of the study is to determine the optimum region(s) of the cochlear promontory in planning for an implantable electrical device for long term tinnitus suppression.
Eligibility Criteria
Inclusion Criteria
- Normal to moderate sensorineural hearing loss (based on pure tone audiometry (PTA) of 500, 1000 and 2000 Hz) and a word recognition score equal to or greater than 60%
- Asymmetric or unilateral subjective tonal tinnitus
- Tinnitus that is disruptive
- Determined by THI score (in the severe range i.e. ≥56/100)
- TFI (in the severe range i.e. ≥52/100)
- Tinnitus VAS (≥ 5/10 )
- Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking
- Normal contrast-enhanced MRI of the head
Exclusion Criteria
- Tinnitus present less than 6 months or longer than 12 years; it is permissible to include people who have had intermittent or constant tinnitus longer than 12 years as long as it was not perceived as severe longer than 12 years
- History of brain or major ear surgery
- Prior major head trauma
- Ongoing clinical diagnosis of depression or anxiety; for the purposes of this study, it is permissible to include people who: 1. have a past history of clinically diagnosed depression or anxiety that is no longer currently active; or 2. people who have depressive or anxious symptoms that are thought to primarily result from severe tinnitus
a. Determined by screening using the GAD 7, PHQ8, and HAI-S
- GAD7 > 9 (indicates clinically significant anxiety)
- PHQ > 9 (indicates clinically significant depression)
- HAI-S > 25 (hypochondriacal level illness anxiety)
- Inability to assess, continue or complete trial
- Currently on regularly scheduled antidepressants, anxiolytics or antipsychotics; for this study, it is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel)
- Active use of other tinnitus treatments; for the purposes of this study it is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss
- Known pregnancy
Data sourced from ClinicalTrials.gov (NCT03759834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.