Trial Outcomes & Findings for Cochlear Promontory Stimulation for Treatment of Tinnitus (NCT NCT03759834)

Last Updated: 2025-09-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Baseline to 4 months

Results posted on

2025-09-10

Participant Flow

Three participants withdrew consent prior to starting treatment.

Participant milestones

Participant milestones
Measure	Testing Arm There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Testing Arm There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Cochlear Promontory Stimulation for Treatment of Tinnitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testing Arm n=22 Participants There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Age, Continuous	59 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 months

Outcome measures

Outcome measures
Measure	Testing Arm n=22 Participants There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Handicap Inventory	-31 score on a scale Interval -38.0 to -25.0

SECONDARY outcome

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

Population: No participants were measured and analyzed for this outcome measure because the principal investigator decided to only use one standard location on the promontory during the study for all participants.

Location on the cochlear promontory where highest perceived benefit from electrical stimulation

Outcome measures

Outcome data not reported

SECONDARY outcome

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

The number of subjects that reported hearing the electrical stimulus (if at all)

Outcome measures

Outcome measures
Measure	Testing Arm n=22 Participants There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Auditory Feedback	22 Participants

SECONDARY outcome

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

The number of subjects that reported feeling the electrical stimulus (if at all)

Outcome measures

Outcome measures
Measure	Testing Arm n=22 Participants There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Tactile Feedback	22 Participants

SECONDARY outcome

Timeframe: Baseline to 4 months

The Tinnitus Functional Index (TFI) contains eight subscales (domains), of which seven contain 3 items and one contains 4. The possible responses for each item range from 0 (did not interfere) to 10 (completely interfered). The total score is transformed to a scale ranging from 0 (no interference) to 100 (completely interfered with activities).

Outcome measures

Outcome measures
Measure	Testing Arm n=22 Participants There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Change in Short Term Relief of Tinnitus as Measured by the Tinnitus Functional Index	-35 score on a scale Interval -42.0 to -28.0

SECONDARY outcome

Timeframe: Baseline to 4 months

The Visual Analog Scale (VAS) for Numeric Pain Distress was used for this outcome. The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 (no pain) and 10 (unbearable pain). Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.

Outcome measures

Outcome measures
Measure	Testing Arm n=22 Participants There was one arm. The patient and investigator were initially blinded to the "on-off" status of the electrode. The patient served as an internal control for testing. Once device integrity and possible benefit was confirmed, the patients underwent non-tactile electrical stimulation to the bone of the inner ear (cochlear promontory) for short term relief of tinnitus via Cochlear promontory stimulation. Cochlear promontory stimulation: 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.
Change in Short Term Relief of Tinnitus as Measured by the Visual Analog Scale	-3.7 score on a scale Interval -4.7 to -2.8

Adverse Events

Testing Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Carlson, M.D., M.B.A.

Mayo Clinic

Phone: 507-284-8532

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place