TinnitusNCT03988699
Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
A study testing Tinnitus Implant System in people with Tinnitus, run by Matthew L. Carlson, M.D. at 1 site in United States.
Trial summary
Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Tinnitus Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years of age
- Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥60% in the ear to be implanted
- Asymmetric or unilateral subjective tonal tinnitus
- Subjectively severe tinnitus present for at least 6 months, but not 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
- Tinnitus that is disruptive by at least two of the three criteria:
- THI in the severe range (≥56/100) TFI in the severe range (≥52/100) Tinnitus VAS-A or Tinnitus VAS-L ≥50/100
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- Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking, when such interventions are potentially clinically indicated (e.g., it is not expected that people with minimal or no hearing loss would trial a conventional hearing aid)
- MRI of the head that does not reveal any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (e.g., vestibular schwannoma)
- Temporal bone CT that does not reveal any major anatomical or structural abnormalities that would negatively impact response to study intervention
- Participants must be able to read, understand, and provide informed consent to participate in the trial
- Participants must be willing and anticipate being able to return for study procedures and follow up visits
- Participants must have completed participation in the study entitled "Cochlear Promontory Stimulation for Treatment of Tinnitus: Towards Developing an Implantable Device" (IRB 17-004832) at Mayo Clinic
Who cannot join
- Age: <18 years of age
- Subjectively severe 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
- History of brain or temporal bone tumor(s)
- Recurrent ear infections within the last year
- Prior major head trauma, defined for the purposes of this study as head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment
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- 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
- Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHIA questionnaires GAD-7 score >9 (indicates clinically significant anxiety) PHQ-8 score >9 (indicates clinically significant depression) SHAI score >25 (hypochondriacal level illness anxiety)
- Currently taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulatory agents; 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 at time of surgery
- Any medical condition, including mental illness or substance abuse, deemed by the PI to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.
Read the detailed description
This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.
- Conditions
- Tinnitus
- Being tested
- Tinnitus Implant System
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus Implant SystemDevice
Device will deliver stimulation below hearing thresholds continuously or intermittently.
| Study group | Role | What they receive |
|---|---|---|
| Subject with severe tinnitus | Experimental | Subjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System. Receives: Device: Tinnitus Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-related adverse events
Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (>10 dB) or worsening in WRS from baseline by a clinically significant amount (>20%) or worsening in video head impulse test result from baseline or one or more serious AEs
Measured: One year
Number of subjects to experience significant improvement from implantation of the device
Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain.
Measured: Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start23 Aug 2021
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew L. Carlson, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew L. Carlson, M.D., Mayo Clinic
- Investigators
- Matthew L Carlson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988699
- Sponsor's protocol ID
- 18-007120
- Status last verified
- Feb 2026
- First submitted
- 7 Jun 2019
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT03988699
- Acronym / sponsor ID
- 18-007120
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Matthew L. Carlson, M.D.University, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.
Detailed description
This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject with severe tinnitus | Experimental | Device: Tinnitus Implant SystemSubjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: ≥18 years of age
- Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥60% in the ear to be implanted
- Asymmetric or unilateral subjective tonal tinnitus
- Subjectively severe tinnitus present for at least 6 months, but not 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
- Tinnitus that is disruptive by at least two of the three criteria:
Key exclusion criteria (12 listed)
- Age: <18 years of age
- Subjectively severe 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
- History of brain or temporal bone tumor(s)
- Recurrent ear infections within the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinnitus Implant SystemDevice will deliver stimulation below hearing thresholds continuously or intermittently. | Device | Subject with severe tinnitus |
Primary outcome
Number of subjects with treatment-related adverse events
Time frame: One year
Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (>10 dB) or worsening in WRS from baseline by a clinically significant amount (>20%) or worsening in video head impulse test result from baseline or one or more serious AEs
Number of subjects to experience significant improvement from implantation of the device
Time frame: Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks
Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew L Carlson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinnitus Implant System in people with Tinnitus, run by Matthew L. Carlson, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with treatment-related adverse events (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.