TinnitusNCT03511807
Acoustic and Electrical Stimulation for the Treatment of Tinnitus
A study testing Electrical and Acoustic in people with Tinnitus, run by University of California, Irvine at 1 site in United States.
Trial summary
Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Electrical and Acoustic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Male or female
- Tinnitus present for 6 months or more
- Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys.
- For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation)
Who cannot join
- Aged less than 18 years
- Active illicit drug use, alcohol dependence
- Treatable cause of tinnitus
- History of psychosis
- Abnormalities of the ear canal or ear drum
- Chronic middle ear disease
- Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hamid Djalilian, MD contact
William Pu, MS contact
United States1 site, 1 recruiting
- Recruiting
Hamid R. Djalilian
Irvine, California, 92612
William Pu, MS, entclinicalstu@hs.uci.edu
Amanda Francis, BA, entclinicalstu@uci.edu
About this study
Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus.
It has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus.
Read more
In both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition.
Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.
Read the detailed description
Tinnitus, or ringing in the ears, is a medical condition that significantly affects the quality of life of patients and that can be disabling to many. It has become known that acoustic and electrical stimulation of the inner ear can cause suppression and sometimes elimination of tinnitus. The long term goal of this study is to devise new methods for reduction/elimination of tinnitus. Multiple attempts at tinnitus suppression using acoustic and electrical stimulation of the inner ear has been performed with variable success. More commonly, acoustic stimulation is used to mask the tinnitus as opposed to suppressing or inhibiting the tinnitus. More recently, however, cochlear implants have been used for hearing as well as tinnitus suppression. The first hypothesis is that in using acoustic stimulation at specific frequencies and levels of loudness, tinnitus can be suppressed / eliminated. The second hypothesis is that using the same electrical stimulation technology as used in the cochlear implant, tinnitus can be suppressed/eliminated. These predictions will be tested in 3 specific aims. In Specific Aim 1, an acoustic sound will be delivered through headphones to the subjects' ears at various frequencies and loudness levels to evaluate suppression / elimination of tinnitus. In Specific Aim 2, an electrical current will be delivered to the inner ear. Pulse trains of various frequencies will be used to evaluate suppression/elimination of the ringing in the ears. Specific Aim 3. The effect of electrical stimulation on the subjects' quality of life will be measured using validated surveys.
In the past, attempts to suppress tinnitus using acoustic stimulation have succeeded in only masking the tinnitus to a limited degree. Tinnitus masking devices only camouflage the tinnitus. Patients frequently report an interference with hearing or complain that the devices only substitute one unpleasant sound for another. Additionally, the masking devices can only be used for a limited time and the patient's tinnitus often subjectively becomes worse after the removal of the device. Patients also become habituated or accustomed to the device thereby decreasing its effectiveness over time.
Attempts to suppress tinnitus using electrical stimulation have a long history. Starting in 1801 and continuing throughout the 19th century, the effects of electrical stimulation on the ear were described by several authors. Some of these early attempts showed that direct current applied to the mastoid or zygoma could suppress and possibly eliminate tinnitus in some patients. Aran et al have found that electrical stimulation of the inner ear via an electrode inserted through the ear drum can cause suppression and sometimes elimination of tinnitus.
The advent of the cochlear implant revolutionized the restoration of hearing to the deaf by electrically stimulating the hearing nerve. As a side-benefit, the cochlear implant was found to suppress tinnitus in 28% to 79% of patients. Electrical stimulation of the inner ear may have a direct electrical influence on the tinnitus generated in the inner ear, or it may have an indirect influence by creating activity centrally where tinnitus reduction occurs. The success with cochlear implants has led to a number of studies to evaluate electrical stimulation for suppression of tinnitus. These studies have used electrodes externally and internally (behind the ear drum) and various stimulus waveforms. They all suggest that in some patients, tinnitus can be suppressed and occasionally eliminated using these techniques. It is important to note that none of these studies was placebo-controlled.
Most recently in a preliminary study in 2003, Rubinstein et al, used a needle electrode passed through the ear drum to suppress tinnitus. The authors used a high pulse rate of 4,800 pulse-per- second (pps) for their electrical stimulation. They found that 5 of 11 (45%) subjects with electrical stimulation of the inner ear through the ear drum using a needle electrode showed substantial or complete tinnitus suppression with either no perception or only a transient perception of the stimulus. Three (27%) showed tinnitus suppression with the perception of the stimulus and three showed no suppression of the tinnitus. In subjects with cochlear implants, the authors used the cochlear implant for tinnitus suppression using the electrical signal sent through the implant to the inner ear. The results of tinnitus suppression using the cochlear implant were similar to the subjects without implants. Based on recent work performed on cochlear implant subjects, it has been found that low pulse rate stimulation may be more beneficial in suppressing tinnitus in cochlear implant patients. Electric stimulation will be delivered through an optically-isolated constant-current source. The maximum output will be set at 1000 microamps and be periodically calibrated to ensure accuracy. This device has been used in several previous studies on hearing perception and a similar device has been used to treat tinnitus . The device is routinely used for cochlear implant patients, but is not routinely used to stimulate people without cochlear implants (given their normal hearing status). It has been used experimentally, however, used for people with hearing loss or tinnitus.
The goal of this study is to expand on these studies and to evaluate the impact of various modes of electrical stimulation for the suppression of tinnitus and to evaluate the quality of life impact of tinnitus suppression on the patients. The predictor variables include frequency, pulse width, and waveform of the electrical stimulation. This study will determine which combination of amplitude, frequency, or waveform will provide the best response. If successful, this method of treating tinnitus could form the basis for development of hopefully the first effective treatment for tinnitus.
The outcome variables include tinnitus level (on a scale of 0-100, with 100 being the loudest level of tinnitus they have experienced), tinnitus handicap inventory score, and Short-form 36 results.
- Conditions
- Tinnitus
- Being tested
- Electrical, Acoustic
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectricalOther
For the electrical stimulation:
An electrode will be inserted into the ear canal which will be stimulated.
AcousticOther
For the acoustic stimulation:
A typical sound will be presented for 6 minutes. Loudness is reported for 4 minutes after the stimulus offset to measure the presence and duration of the residual inhibition. If a successful acoustic stimulus is found, the subject will be given a series of sound files to listen to on a digital music player (CD or MP3 player) and will be asked to listen to each sound file (5 minute duration) and record their tinnitus loudness/annoyance during and after each sound stimulation. For some subjects, the investigators will use music on a digital music player (MP3 player) to see if music listening and music exercises will help reduce the intensity or annoyance level of the tinnitus (using the same surveys). These music-based exercises will involve training in recognition of musical intervals (e.g., octaves, fifths, and thirds).
| Study group | Role | What they receive |
|---|---|---|
| Electrical/ Acoustic stimulation | Experimental | Not described Receives: Other: Electrical; Other: Acoustic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiogram
Measures hearing ability in db hearing loss (HL).
Measured: Occurs once at the beginning of subject participation (less than one hour)
Otoacoustic Emissions (OAE)
Measures health of the inner ear in db hearing loss (HL).
Measured: Occurs once at the beginning of subject participation (less than one hour)
Tinnitus Handicap Inventory (THI)
Quantifies and evaluates difficulties experience because of tinnitus measured in a numerical score range: Yes (value of 4, highest) Sometimes (value of 2) and No (value of 0, lowest). The sum of all responses yields a total THI score (0-100). High scores indicate catastrophic handicap. Low scores indicate slight or no handicap.
Measured: Outcome will be measured during each participant visit through study completion which can be an average of 1 year
Medical Outcomes Study Questionnaire Short Form 36 (SF-36) Health Survey Quality of life metrics.
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores indicate more disability, higher scores indicate less disability.
Measured: Outcome will be measured during each participant visit through study completion which can be an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Jan 2017
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Djalilian, University of California, Irvine
- Investigators
- Hamid Djalilian, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511807
- Sponsor's protocol ID
- 20065187
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2018
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldman H. History of tinnitus research. In: Shulman A, ed. Tinnitus Diagnosis/Treatment. San Diego: Singular Publishing Group; 1997:3-37.
de Sauvage RC, Cazals Y, Aran JM. Observation of an electrically evoked whole-nerve response using the same stimulating and recording electrode: an image of the unit response at the round window (preliminary report). Hear Res. 1980 Jun;2(3-4):343-6. doi: 10.1016/0378-5955(80)90068-4. No abstract available.
PubMed 7410238Zwolan TA, Kileny PR, Souliere CR, Kemink JL. Tinnitus suppression following cochlear implantation. In: Aran J-M, Dauman R, eds. Tinnitus 91: Proceedings of the Fourth International Tinnitus Seminar. Amsterdam: Kugler, 1992;423-6.
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.
PubMed 12806303Kuk FK, Tyler RS, Rustad N, Harker LA, Tye-Murray N. Alternating current at the eardrum for tinnitus reduction. J Speech Hear Res. 1989 Jun;32(2):393-400. doi: 10.1044/jshr.3202.393.
PubMed 2786979Hazell JW, Jastreboff PJ, Meerton LE, Conway MJ. Electrical tinnitus suppression: frequency dependence of effects. Audiology. 1993;32(1):68-77. doi: 10.3109/00206099309072929.
PubMed 8447763Okusa M, Shiraishi T, Kubo T, Matsunaga T. Tinnitus suppression by electrical promontory stimulation in sensorineural deaf patients. Acta Otolaryngol Suppl. 1993;501:54-8. doi: 10.3109/00016489309126215.
PubMed 8447227Ito J, Sakakihara J. Tinnitus suppression by electrical stimulation of the cochlear wall and by cochlear implantation. Laryngoscope. 1994 Jun;104(6 Pt 1):752-4. doi: 10.1288/00005537-199406000-00017.
PubMed 8196452Matsushima JI, Sakai N, Uemi N, Miyoshi S, Sakajiri M, Ifukube T. Evaluation of Implanted Tinnitus Suppressor Based on Tinnitus Stress Test. Int Tinnitus J. 1997;3(2):123-131.
PubMed 10753374Shulman A. External electrical stimulation in tinnitus control. Am J Otol. 1985 Jan;6(1):110-5. No abstract available.
PubMed 3872077Vurek LS, White M, Fong M, Walsh SM. Opto-isolated stimulators used for electrically evoked BSER: some observations on electrical artifact. Ann Otol Rhinol Laryngol Suppl. 1981 Mar-Apr;90(2 Pt 3):21-4. doi: 10.1177/00034894810902s208. No abstract available.
PubMed 6784647Zeng FG, Shannon RV. Loudness-coding mechanisms inferred from electric stimulation of the human auditory system. Science. 1994 Apr 22;264(5158):564-6. doi: 10.1126/science.8160013.
PubMed 8160013
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic and Electrical Stimulation for the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT03511807
- Acronym / sponsor ID
- 20065187
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 30 Apr 2018 (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.
Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus.
It has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus.
In both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition.
Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.
Detailed description
Tinnitus, or ringing in the ears, is a medical condition that significantly affects the quality of life of patients and that can be disabling to many. It has become known that acoustic and electrical stimulation of the inner ear can cause suppression and sometimes elimination of tinnitus. The long term goal of this study is to devise new methods for reduction/elimination of tinnitus. Multiple attempts at tinnitus suppression using acoustic and electrical stimulation of the inner ear has been performed with variable success. More commonly, acoustic stimulation is used to mask the tinnitus as opposed to suppressing or inhibiting the tinnitus. More recently, however, cochlear implants have been used for hearing as well as tinnitus suppression. The first hypothesis is that in using acoustic stimulation at specific frequencies and levels of loudness, tinnitus can be suppressed / eliminated. The second hypothesis is that using the same electrical stimulation technology as used in the cochlear implant, tinnitus can be suppressed/eliminated. These predictions will be tested in 3 specific aims. In Specific Aim 1, an acoustic sound will be delivered through headphones to the subjects' ears at various frequencies and loudness levels to evaluate suppression / elimination of tinnitus. In Specific Aim 2, an electrical current will be delivered to the inner ear. Pulse trains of various frequencies will be used to evaluate suppression/elimination of the ringing in the ears. Specific Aim 3. The effect of electrical stimulation on the subjects' quality of life will be measured using validated surveys.
In the past, attempts to suppress tinnitus using acoustic stimulation have succeeded in only masking the tinnitus to a limited degree. Tinnitus masking devices only camouflage the tinnitus. Patients frequently report an interference with hearing or complain that the devices only substitute one unpleasant sound for another. Additionally, the masking devices can only be used for a limited time and the patient's tinnitus often subjectively becomes worse after the removal of the device. Patients also become habituated or accustomed to the device thereby decreasing its effectiveness over time.
Attempts to suppress tinnitus using electrical stimulation have a long history. Starting in 1801 and continuing throughout the 19th century, the effects of electrical stimulation on the ear were described by several authors. Some of these early attempts showed that direct current applied to the mastoid or zygoma could suppress and possibly eliminate tinnitus in some patients. Aran et al have found that electrical stimulation of the inner ear via an electrode inserted through the ear drum can cause suppression and sometimes elimination of tinnitus.
The advent of the cochlear implant revolutionized the restoration of hearing to the deaf by electrically stimulating the hearing nerve. As a side-benefit, the cochlear implant was found to suppress tinnitus in 28% to 79% of patients. Electrical stimulation of the inner ear may have a direct electrical influence on the tinnitus generated in the inner ear, or it may have an indirect influence by creating activity centrally where tinnitus reduction occurs. The success with cochlear implants has led to a number of studies to evaluate electrical stimulation for suppression of tinnitus. These studies have used electrodes externally and internally (behind the ear drum) and various stimulus waveforms. They all suggest that in some patients, tinnitus can be suppressed and occasionally eliminated using these techniques. It is important to note that none of these studies was placebo-controlled.
Most recently in a preliminary study in 2003, Rubinstein et al, used a needle electrode passed through the ear drum to suppress tinnitus. The authors used a high pulse rate of 4,800 pulse-per- second (pps) for their electrical stimulation. They found that 5 of 11 (45%) subjects with electrical stimulation of the inner ear through the ear drum using a needle electrode showed substantial or complete tinnitus suppression with either no perception or only a transient perception of the stimulus. Three (27%) showed tinnitus suppression with the perception of the stimulus and three showed no suppression of the tinnitus. In subjects with cochlear implants, the authors used the cochlear implant for tinnitus suppression using the electrical signal sent through the implant to the inner ear. The results of tinnitus suppression using the cochlear implant were similar to the subjects without implants. Based on recent work performed on cochlear implant subjects, it has been found that low pulse rate stimulation may be more beneficial in suppressing tinnitus in cochlear implant patients. Electric stimulation will be delivered through an optically-isolated constant-current source. The maximum output will be set at 1000 microamps and be periodically calibrated to ensure accuracy. This device has been used in several previous studies on hearing perception and a similar device has been used to treat tinnitus . The device is routinely used for cochlear implant patients, but is not routinely used to stimulate people without cochlear implants (given their normal hearing status). It has been used experimentally, however, used for people with hearing loss or tinnitus.
The goal of this study is to expand on these studies and to evaluate the impact of various modes of electrical stimulation for the suppression of tinnitus and to evaluate the quality of life impact of tinnitus suppression on the patients. The predictor variables include frequency, pulse width, and waveform of the electrical stimulation. This study will determine which combination of amplitude, frequency, or waveform will provide the best response. If successful, this method of treating tinnitus could form the basis for development of hopefully the first effective treatment for tinnitus.
The outcome variables include tinnitus level (on a scale of 0-100, with 100 being the loudest level of tinnitus they have experienced), tinnitus handicap inventory score, and Short-form 36 results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical/ Acoustic stimulation | Experimental | Other: Electrical, Other: Acoustic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Male or female
- Tinnitus present for 6 months or more
- Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys.
- For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation)
Key exclusion criteria (8 listed)
- Aged less than 18 years
- Active illicit drug use, alcohol dependence
- Treatable cause of tinnitus
- History of psychosis
- Abnormalities of the ear canal or ear drum
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 |
|---|---|---|
| ElectricalFor the electrical stimulation: An electrode will be inserted into the ear canal which will be stimulated. | Other | Electrical/ Acoustic stimulation |
| AcousticFor the acoustic stimulation: A typical sound will be presented for 6 minutes. Loudness is reported for 4 minutes after the stimulus offset to measure the presence and duration of the residual inhibition. If a successful acoustic stimulus is found, the subject will be given a series of sound files to listen to on a digital music player (CD or MP3 player) and will be asked to listen to each sound file (5 minute duration) and record their tinnitus loudness/annoyance during and after each sound stimulation. For some subjects, the investigators will use music on a digital music player (MP3 player) to see if music listening and music exercises will help reduce the intensity or annoyance level of the tinnitus (using the same surveys). These music-based exercises will involve training in recognition of musical intervals (e.g., octaves, fifths, and thirds). | Other | Electrical/ Acoustic stimulation |
Primary outcome
Audiogram
Time frame: Occurs once at the beginning of subject participation (less than one hour)
Measures hearing ability in db hearing loss (HL).
Otoacoustic Emissions (OAE)
Time frame: Occurs once at the beginning of subject participation (less than one hour)
Measures health of the inner ear in db hearing loss (HL).
Tinnitus Handicap Inventory (THI)
Time frame: Outcome will be measured during each participant visit through study completion which can be an average of 1 year
Quantifies and evaluates difficulties experience because of tinnitus measured in a numerical score range: Yes (value of 4, highest) Sometimes (value of 2) and No (value of 0, lowest). The sum of all responses yields a total THI score (0-100). High scores indicate catastrophic handicap. Low scores indicate slight or no handicap.
Medical Outcomes Study Questionnaire Short Form 36 (SF-36) Health Survey Quality of life metrics.
Time frame: Outcome will be measured during each participant visit through study completion which can be an average of 1 year
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores indicate more disability, higher scores indicate less disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- BackgroundFeldman H. History of tinnitus research. In: Shulman A, ed. Tinnitus Diagnosis/Treatment. San Diego: Singular Publishing Group; 1997:3-37.
- Background: PubMed 7410238de Sauvage RC, Cazals Y, Aran JM. Observation of an electrically evoked whole-nerve response using the same stimulating and recording electrode: an image of the unit response at the round window (preliminary report). Hear Res. 1980 Jun;2(3-4):343-6. doi: 10.1016/0378-5955(80)90068-4. No abstract available.
- BackgroundZwolan TA, Kileny PR, Souliere CR, Kemink JL. Tinnitus suppression following cochlear implantation. In: Aran J-M, Dauman R, eds. Tinnitus 91: Proceedings of the Fourth International Tinnitus Seminar. Amsterdam: Kugler, 1992;423-6.
- Background: PubMed 12806303Rubinstein 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.
- Background: PubMed 2786979Kuk FK, Tyler RS, Rustad N, Harker LA, Tye-Murray N. Alternating current at the eardrum for tinnitus reduction. J Speech Hear Res. 1989 Jun;32(2):393-400. doi: 10.1044/jshr.3202.393.
- Background: PubMed 8447763Hazell JW, Jastreboff PJ, Meerton LE, Conway MJ. Electrical tinnitus suppression: frequency dependence of effects. Audiology. 1993;32(1):68-77. doi: 10.3109/00206099309072929.
- Background: PubMed 8447227Okusa M, Shiraishi T, Kubo T, Matsunaga T. Tinnitus suppression by electrical promontory stimulation in sensorineural deaf patients. Acta Otolaryngol Suppl. 1993;501:54-8. doi: 10.3109/00016489309126215.
- Background: PubMed 8196452Ito J, Sakakihara J. Tinnitus suppression by electrical stimulation of the cochlear wall and by cochlear implantation. Laryngoscope. 1994 Jun;104(6 Pt 1):752-4. doi: 10.1288/00005537-199406000-00017.
- Background: PubMed 10753374Matsushima JI, Sakai N, Uemi N, Miyoshi S, Sakajiri M, Ifukube T. Evaluation of Implanted Tinnitus Suppressor Based on Tinnitus Stress Test. Int Tinnitus J. 1997;3(2):123-131.
- Background: PubMed 3872077Shulman A. External electrical stimulation in tinnitus control. Am J Otol. 1985 Jan;6(1):110-5. No abstract available.
- Background: PubMed 6784647Vurek LS, White M, Fong M, Walsh SM. Opto-isolated stimulators used for electrically evoked BSER: some observations on electrical artifact. Ann Otol Rhinol Laryngol Suppl. 1981 Mar-Apr;90(2 Pt 3):21-4. doi: 10.1177/00034894810902s208. No abstract available.
- Background: PubMed 8160013Zeng FG, Shannon RV. Loudness-coding mechanisms inferred from electric stimulation of the human auditory system. Science. 1994 Apr 22;264(5158):564-6. doi: 10.1126/science.8160013.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
Hamid Djalilian, MD contact
William Pu, MS contact
Hamid Djalilian, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical and Acoustic in people with Tinnitus, run by University of California, Irvine 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamid Djalilian, MD (tinnitus@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Audiogram (time frame: Occurs once at the beginning of subject participation (less than one hour)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511807, which also lists 12 linked publications.
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 11 Jun 2026.