Cochlear Promontory Stimulation for Treatment of Tinnitus

NCT03759834 | Completed Results FDA Device

• 2 other identifiers: 17-004832PR180961
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory

  The Tinnitus Handicap Inventory (THI) has 25 questions with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points). Scores categories are (1-16: Slight or no handicap - Grade 1), (18-36: Mild handicap - Grade 2), (38-56: Moderate handicap - Grade 3), (58-76: Severe handicap - Grade 4), (78-100: Catastrophic handicap - Grade 5). Total score ranges from 0 to 100 with higher scores indicating a worse outcome.

  Baseline to 4 months

Secondary Outcomes (5)

• Optimal Location of Tinnitus Relief

  Immediately after electrical stimulation procedure (approximately 1 min after stimulation)

• Auditory Feedback

  Immediately after electrical stimulation procedure (approximately 1 min after stimulation)

• Tactile Feedback

  Immediately after electrical stimulation procedure (approximately 1 min after stimulation)

• Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index

  Baseline to 4 months

• Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale

  Baseline to 4 months

Study Arms (1)

Testing Arm

EXPERIMENTAL

There will only be one arm. The patient and investigator will initially be blinded to the "on-off" status of the electrode. The patient will thus serve as an internal control for testing. Once device integrity and possible benefit is confirmed, the patients will undergo non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation.

Device: Cochlear promontory stimulation

Interventions

Cochlear promontory stimulation DEVICE

Promontory stimulation is an established otologic procedure that was initially developed as a diagnostic tool to assess patient candidacy for cochlear implantation. Promontory stimulation is most commonly performed in the outpatient setting on an awake patient by placing a single insulated probe through a topically anesthetized tympanic membrane and applying monopolar current for several seconds to minutes. The initial session of promontory stimulation will define optimal stimulation parameters (i.e., location, current level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal or no auditory percept. Additional stimulation testing visits will confirm these findings.

Testing Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• United States Department of Defense: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (13)

• Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus. Otolaryngol Head Neck Surg. 2014 Oct;151(2 Suppl):S1-S40. doi: 10.1177/0194599814545325.

  PMID: 25273878 BACKGROUND

• Tsai BS, Sweetow RW, Cheung SW. Audiometric asymmetry and tinnitus laterality. Laryngoscope. 2012 May;122(5):1148-53. doi: 10.1002/lary.23242. Epub 2012 Mar 23.

  PMID: 22447577 BACKGROUND

• Perez R, Shaul C, Vardi M, Muhanna N, Kileny PR, Sichel JY. Multiple electrostimulation treatments to the promontory for tinnitus. Otol Neurotol. 2015 Feb;36(2):366-72. doi: 10.1097/MAO.0000000000000309.

  PMID: 24691511 BACKGROUND

• Rubinstein JT, Tyler RS, Johnson A, Brown CJ. Electrical suppression of tinnitus with high-rate pulse trains. Otol Neurotol. 2003 May;24(3):478-85. doi: 10.1097/00129492-200305000-00021.

  PMID: 12806303 BACKGROUND

• Watanabe K, Okawara D, Baba S, Yagi T. Electrocochleographic analysis of the suppression of tinnitus by electrical promontory stimulation. Audiology. 1997 May-Jun;36(3):147-54. doi: 10.3109/00206099709071968.

  PMID: 9193732 BACKGROUND

• Steenerson RL, Cronin GW. Treatment of tinnitus with electrical stimulation. Otolaryngol Head Neck Surg. 1999 Nov;121(5):511-3. doi: 10.1016/S0194-5998(99)70048-3.

  PMID: 10547461 BACKGROUND

• Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. 2016 Jan;331:1-6. doi: 10.1016/j.heares.2015.09.016. Epub 2015 Oct 24.

  PMID: 26433053 BACKGROUND

• Tyler RS. Patient preferences and willingness to pay for tinnitus treatments. J Am Acad Audiol. 2012 Feb;23(2):115-25. doi: 10.3766/jaaa.23.2.6.

  PMID: 22353680 BACKGROUND

• Arts RA, George EL, Stokroos RJ, Vermeire K. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):398-403. doi: 10.1097/MOO.0b013e3283577b66.

  PMID: 22931903 BACKGROUND

• Arts RA, George EL, Chenault MN, Stokroos RJ. Optimizing intracochlear electrical stimulation to suppress tinnitus. Ear Hear. 2015 Jan;36(1):125-35. doi: 10.1097/AUD.0000000000000090.

  PMID: 25090456 BACKGROUND

• Zeman F, Koller M, Figueiredo R, Aazevedo A, Rates M, Coelho C, Kleinjung T, de Ridder D, Langguth B, Landgrebe M. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? Otolaryngol Head Neck Surg. 2011 Aug;145(2):282-7. doi: 10.1177/0194599811403882.

  PMID: 21493265 BACKGROUND

• Topf MC, Hsu DW, Adams DR, Zhan T, Pelosi S, Willcox TO, McGettigan B, Fisher KW. Rate of tympanic membrane perforation after intratympanic steroid injection. Am J Otolaryngol. 2017 Jan-Feb;38(1):21-25. doi: 10.1016/j.amjoto.2016.09.004. Epub 2016 Sep 28.

  PMID: 27751619 BACKGROUND

• Marinelli JP, Anzalone CL, Prummer CM, Poling GL, Staab JP, Tombers NM, Lohse CM, Carlson ML. Electrical stimulation of the cochlea for treatment of chronic disabling tinnitus: an open-label trial towards the development of an implantable device. J Transl Med. 2022 Jan 29;20(1):56. doi: 10.1186/s12967-022-03271-4.

  PMID: 35093126 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matthew Carlson, M.D., M.B.A.
• Organization: Mayo Clinic

Carlson.Matthew@mayo.edu

507-284-8532

Study Officials

• Matthew L Carlson

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The electrode will be placed in the middle ear. The patient and investigator will be blinded to the "on-off" status of the device. The patient will report if they have improvement of their tinnitus while both the patient and investigator are blinded to the "on-off" status.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: November 30, 2018
• Study Start: January 4, 2018
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)