TinnitusTINISNCT06641999
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
A study testing Tinnitus Implant System in people with Tinnitus and Hearing Loss, Bilateral or Unilateral, run by Cochlear at 2 sites in 2 countries.
Trial summary
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Hearing Loss, Bilateral or Unilateral, Normal Hearing
- 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
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jun 2025to Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older.
- Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average (PTA) at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears (separately) and best-aided phoneme recognition score more than or equal to 80% in both ears (separately).
- Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of asymmetric tinnitus, the worst ear must be implanted.
- Tinnitus duration of at least 6 months.
- Severe tinnitus loudness determined by a. VAS-L score in the severe range i.e. 50-100/100 b. TFI score in the severe range i.e. 52-90/100
- Tinnitus that is intractable and has not been ameliorated satisfactorily by standard of care such as CBT or hearing aid, when such interventions are potentially clinically indicated.
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- Clinically significant reduction in VAS-L score (≥ 15/100 points) in response to trans-tympanic promontory stimulation
- Willing and able to provide written informed consent.
- Medically able to use the device and to undergo general anaesthesia for implantation taking into account their medical condition, contraindications and surgical risks.
- Dutch language proficiency
Who cannot join
- Pulsatile tinnitus.
- Any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (determined in a temporal bone CT and if necessary (e.g. possibility of vestibular/acoustic schwannoma) by a MRI scan of the head (of sufficient quality at the discretion of the investigator) not more than five years old at the time of enrolment
- Medical contraindications limiting correct placement, activation, or treatment (determined by medical history; contraindications include brain or major ear surgery, brain or temporal bone tumor(s), recurrent ear infections within the last year, otosclerosis, prior major head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment).
- Any medical condition, including mental illness or substance abuse, deemed by the Investigator to likely interfere with a patient's ability to sign informed consent, cooperate and/or participate in the study, or interfere with the interpretation of the results (incl. pregnant or breastfeeding women or patients with unrealistic expectations).
- Presence of clinically diagnosed depression or anxiety determined by a psychological state evaluation (if PHQ-9 > 9 or GAD-7 > 9).
- Active (currently or within two months prior to enrolment) use of medications (taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulator agents) or other tinnitus treatments.
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- 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). A change in medication during the trial should be avoided.
- It is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss. The start of using a hearing aid during the trial should be avoided.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 60 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Kelly Assouly contact
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital (UZA)
Edegem, Belgium, B-2650
Prof. Dr. Marc Lammers, +32 3 821 33 85, Marc.Lammers@uza.be
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3508
Prof. Dr. Robert J. Stokroos, +31 88 75 566 44, R.J.Stokroos@umcutrecht.nl
About this study
Official title: A Prospective, Multicentric, Feasibility Investigation to Assess the Effect of the Tinnitus Implant on Tinnitus Loudness in Adults With Moderate to Severe Chronic Tinnitus Accompanied by Normal Hearing to Moderately Severe Hearing Loss.
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.
- Being tested
- Tinnitus Implant System
- Keywords
- tinnitus, cochlear implant
- Medical subject headings
- Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus Implant SystemDevice
Implanted with Tinnitus Implant System: Active Implantable Medical Device
| Study group | Role | What they receive |
|---|---|---|
| Tinnitus Implant System | Experimental | Tinnitus Implant Receives: Device: Tinnitus Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Loudness (VAS-L) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest loudness severity
Measured: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Secondary outcomes (8)
Reported device or procedure related adverse events and harms
Number of device and procedure-related adverse events and reported harms
Measured: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in tinnitus annoyance from baseline to 6 months post activation of the Tinnitus Implant System
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Annoyance (VAS-A) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest annoyance severity
Measured: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in tinnitus perception from baseline to 6 months post activation of the Tinnitus Implant System
Self-reporting on the Tinnitus Functional Index (TFI) questionnaire
Measured: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Change in self-reported matches of tinnitus pitch and loudness to acoustic stimuli
Patient reported matching of tinnitus pitch (Hz) and loudness (dB SPL) with acoustic stimuli
Measured: Pre-operative baseline, activation (Implant activation is approximately 10 weeks after surgical implantation of Tinnitus implant), 3 months post activation, 6 months post activation
Mean change in health-related quality of life with Tinnitus Implant System
Score of Glasgow Benefit Inventory (GBI) questionnaire
Measured: 6 months post Tinnitus Implant System activation
Mean change in health status with Tinnitus Implant System
Score of Patient Global Impression of Change (PGIC) questionnaire
Measured: At 6 months post Tinnitus Implant System activation
Mean change in speech perception in quiet from baseline to 6 months post-activation
Word recognition in quiet presented at 65 dB SPL in the unaided condition
Measured: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in hearing thresholds from baseline to 6 months post-activation
Bone conduction thresholds (dB HL) at any tested frequency (0.25, 0.5, 1, 1.5, 2, 4 kHz) from baseline to 6 months post-activation in the implanted ear
Measured: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start16 Jun 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
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.
- More trials run by CochlearThe 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Remo Arts, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641999
- Sponsor's protocol ID
- AI5856
- Acronym
- TINIS
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Feasibility Investigation to Assess the Effect of the Tinnitus Implant on Tinnitus Loudness in Adults With Moderate to Severe Chronic Tinnitus Accompanied by Normal Hearing to Moderately Severe Hearing Loss.
- ClinicalTrials.gov ID
- NCT06641999
- Acronym / sponsor ID
- TINIS / AI5856
- Keywords
- tinnitus, cochlear implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tinnitus Implant System | Experimental | Device: Tinnitus Implant SystemTinnitus Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years or older.
- Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average (PTA) at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears (separately) and best-aided phoneme recognition score more than or equal to 80% in both ears (separately).
- Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of asymmetric tinnitus, the worst ear must be implanted.
- Tinnitus duration of at least 6 months.
- Severe tinnitus loudness determined by a. VAS-L score in the severe range i.e. 50-100/100 b. TFI score in the severe range i.e. 52-90/100
Key exclusion criteria (11 listed)
- Pulsatile tinnitus.
- Any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (determined in a temporal bone CT and if necessary (e.g. possibility of vestibular/acoustic schwannoma) by a MRI scan of the head (of sufficient quality at the discretion of the investigator) not more than five years old at the time of enrolment
- Medical contraindications limiting correct placement, activation, or treatment (determined by medical history; contraindications include brain or major ear surgery, brain or temporal bone tumor(s), recurrent ear infections within the last year, otosclerosis, prior major head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment).
- Any medical condition, including mental illness or substance abuse, deemed by the Investigator to likely interfere with a patient's ability to sign informed consent, cooperate and/or participate in the study, or interfere with the interpretation of the results (incl. pregnant or breastfeeding women or patients with unrealistic expectations).
- Presence of clinically diagnosed depression or anxiety determined by a psychological state evaluation (if PHQ-9 > 9 or GAD-7 > 9).
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 SystemImplanted with Tinnitus Implant System: Active Implantable Medical Device | Device | Tinnitus Implant System |
Primary outcome
Mean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Self-reported tinnitus loudness as measured on the Visual Analogue Scale-Loudness (VAS-L) where 0 is equivalent to absence of tinnitus and 100 indicates tinnitus of the greatest loudness severity
8 secondary outcomes
Reported device or procedure related adverse events and harms
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in tinnitus annoyance from baseline to 6 months post activation of the Tinnitus Implant System
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in tinnitus perception from baseline to 6 months post activation of the Tinnitus Implant System
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Change in self-reported matches of tinnitus pitch and loudness to acoustic stimuli
Time frame: Pre-operative baseline, activation (Implant activation is approximately 10 weeks after surgical implantation of Tinnitus implant), 3 months post activation, 6 months post activation
Mean change in health-related quality of life with Tinnitus Implant System
Time frame: 6 months post Tinnitus Implant System activation
Mean change in health status with Tinnitus Implant System
Time frame: At 6 months post Tinnitus Implant System activation
Mean change in speech perception in quiet from baseline to 6 months post-activation
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
Mean change in hearing thresholds from baseline to 6 months post-activation
Time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation
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 2 Jun 2026.
- 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.
Kelly Assouly contact
Remo Arts study director
Cochlear
2 sites in 2 countries: 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 and Hearing Loss, Bilateral or Unilateral, run by Cochlear at 2 sites in 2 countries.
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 10 inclusion and 11 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 2 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 2 sites in Belgium, Netherlands. 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 Remo Arts (+31615326086, rarts@cochlear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in tinnitus loudness from baseline to 6 months post-activation of the Tinnitus Implant System (time frame: Pre-operative baseline to 6 months post Tinnitus Implant System activation). 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 2 Jun 2026.