Sensorineural Hearing LossEXCITENCT07893860
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
A study testing Cochlear implant in people with Sensorineural Hearing Loss and Tinnitus, run by Cochlear at 1 site in Spain.
Trial summary
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss, Tinnitus
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2027to Apr 2028
- 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
- Individuals aged 18 years and older at time of consent.
- Meets local candidacy criteria for cochlear implantation in the ear to be implanted.
- Failure to satisfactorily treat tinnitus with conventional treatments including Tinnitus Retraining Therapy (TRT) for at least six (6) months as determined by the investigator.
- Moderate to severe tinnitus handicap as determined by >38 THI score (Grade 3 / Moderate or greater).
- Duration of moderate to severe tinnitus < 3 years, as determined by the investigator.
- Willing to undergo unilateral cochlear implantation.
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- Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator (i.e. Spanish).
- Direct access to a compatible Smart Phone.
- Willing and able to provide written informed consent.
Who cannot join
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Participants who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Tinnitus of central origin, pulsatile tinnitus related to blood flow, paroxysmal tinnitus, somatosensory tinnitus, tinnitus related to vertigo or headache, or post-traumatic tinnitus, as determined by the investigator.
- Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
- Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
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- Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
- Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
- Cochlear ossification, cochlear malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
- Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
- Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.
- Severe, or poorer, sensorineural hearing loss for more than 15 years, as reported by the participant, in the ear to be implanted.
- Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.
- Preexisting skin condition that could jeopardize wound healing, as determined by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
- Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
- Additional disabilities that may affect the participant's participation or safety during the clinical investigation.
- Pregnant women.
- Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device that is different from the device in this study.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Silivi Andrea Borokoski Barriero contact
Spain1 site
Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
Angel Ramos Macias Prof., Doctor, +34 609564507, ramosorl@idecnet.com
Silvia Andrea Borkoski Barreiro, silviaborkoski@hotmail.com
About this study
Official title: A Prospective, Interventional, Repeated Measures Feasibility Study to Evaluate Change in Tinnitus Severity for Adult Recipients of a Totally Implantable Cochlear Implant System Who Experience Tinnitus Pre-Operatively
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
Read the detailed description
Many studies show that cochlear implants can improve hearing and speech understanding in people with severe-to-profound sensorineural hearing loss. Beyond these hearing benefits, many recipients also report reduced tinnitus when using their cochlear implant. Tinnitus relief usually occurs while the cochlear implant is active and may remain stable over time. Some recipients may also continue to experience reduced tinnitus for a period after the implant is switched off. A totally implantable cochlear implant may provide additional benefit for people with hearing loss and moderate-to-severe tinnitus. Unlike a conventional cochlear implant, it can provide auditory stimulation during the day and night, including during sleep, when an external sound processor is usually removed.
- Conditions
- Sensorineural Hearing Loss, Tinnitus
- Being tested
- Cochlear implant
- Keywords
- cochlear implant
- Medical subject headings
- Hearing Loss, Sensorineural, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
TICI G2 Clinical Investigation System
| Study group | Role | What they receive |
|---|---|---|
| Totally Implantable Cochlear Implant System | Experimental | Participants will be implanted with the TI1132 implant Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of the TICI G2 Clinical Investigation System usage on Tinnitus Handicap Inventory (THI) ratings
Mean within-subject change in THI score. The THI measures tinnitus severity. The score ranges from Slight or No handicap (Grade 1): 0-16, Mild (Grade 2): 18-36, Moderate (Grade 3): 38-56, Severe (Grade 4): 58-76 to Catastrophic (Grade 5): 78-100
Measured: Preoperative baseline to 6- months post-activation
Secondary outcomes (6)
Evaluate the change to speech perception using the TICI G2 Clinical Investigation System with external hearing (EH) compared with baseline in the ear to be implanted
Mean within subject change in speech in quiet from baseline as measured by word recognition using external hearing (sound processor on)
Measured: Pre-operative baseline to 6-months post-activation
Evaluate the change to speech perception using the TICI G2 Clinical Investigation System with invisible hearing (IH) compared with baseline in the ear to be implanted
Mean within subject change in speech in quiet from baseline as measured by word recognition using invisible hearing (sound processor off)
Measured: Pre-operative baseline to 6-months post-activation
Evaluate the subjective ratings of hearing ability in the preferred bilateral listening mode
Mean within subject change in the global score of the Speech, Spatial and Qualities of Hearing Scale (SSQ12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability).
Measured: Pre-operative baseline to 6-months post-activation
Evaluate the overall health status as measured by the Health Utilities Index (HUI2/3)
Mean within subject change in the global score of the Health Utilities Index (HUI2/3). Scores range from -0.36 to 1.00, where a negative score represents a state "worse than dead" and a top score of 1.00 is "perfect health".
Measured: Pre-operative baseline to 6-months post-activation
Evaluate the impact of the TICI G2 Clinical Investigation System usage on THI ratings
Mean within-subject change in THI score. The THI measures tinnitus severity. The score ranges from Slight or No handicap (Grade 1): 0-16, Mild (Grade 2): 18-36, Moderate (Grade 3): 38-56, Severe (Grade 4): 58-76 to Catastrophic (Grade 5): 78-100
Measured: Pre-operative baseline to 3-months post-activation
Characterize the device usage over time of TICI G2 Clinical Investigation System
Average daily time on air, collected through software data logs of device use.
Measured: Activation to 6-months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angel Ramos Marcias, Prof. Doctor, Principal investigator, Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria Las Palmas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893860
- Sponsor's protocol ID
- CLTD03389
- Acronym
- EXCITE
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Interventional, Repeated Measures Feasibility Study to Evaluate Change in Tinnitus Severity for Adult Recipients of a Totally Implantable Cochlear Implant System Who Experience Tinnitus Pre-Operatively
- ClinicalTrials.gov ID
- NCT07893860
- Acronym / sponsor ID
- EXCITE / CLTD03389
- Conditions
- Sensorineural Hearing Loss, Tinnitus
- Keywords
- cochlear implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
Detailed description
Many studies show that cochlear implants can improve hearing and speech understanding in people with severe-to-profound sensorineural hearing loss. Beyond these hearing benefits, many recipients also report reduced tinnitus when using their cochlear implant. Tinnitus relief usually occurs while the cochlear implant is active and may remain stable over time. Some recipients may also continue to experience reduced tinnitus for a period after the implant is switched off. A totally implantable cochlear implant may provide additional benefit for people with hearing loss and moderate-to-severe tinnitus. Unlike a conventional cochlear implant, it can provide auditory stimulation during the day and night, including during sleep, when an external sound processor is usually removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Totally Implantable Cochlear Implant System | Experimental | Device: Cochlear implantParticipants will be implanted with the TI1132 implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals aged 18 years and older at time of consent.
- Meets local candidacy criteria for cochlear implantation in the ear to be implanted.
- Failure to satisfactorily treat tinnitus with conventional treatments including Tinnitus Retraining Therapy (TRT) for at least six (6) months as determined by the investigator.
- Moderate to severe tinnitus handicap as determined by >38 THI score (Grade 3 / Moderate or greater).
- Duration of moderate to severe tinnitus < 3 years, as determined by the investigator.
Key exclusion criteria (21 listed)
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Participants who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Tinnitus of central origin, pulsatile tinnitus related to blood flow, paroxysmal tinnitus, somatosensory tinnitus, tinnitus related to vertigo or headache, or post-traumatic tinnitus, as determined by the investigator.
- Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
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 |
|---|---|---|
| Cochlear implantTICI G2 Clinical Investigation System | Device | Totally Implantable Cochlear Implant System |
Primary outcome
Evaluate the impact of the TICI G2 Clinical Investigation System usage on Tinnitus Handicap Inventory (THI) ratings
Time frame: Preoperative baseline to 6- months post-activation
Mean within-subject change in THI score. The THI measures tinnitus severity. The score ranges from Slight or No handicap (Grade 1): 0-16, Mild (Grade 2): 18-36, Moderate (Grade 3): 38-56, Severe (Grade 4): 58-76 to Catastrophic (Grade 5): 78-100
6 secondary outcomes
Evaluate the change to speech perception using the TICI G2 Clinical Investigation System with external hearing (EH) compared with baseline in the ear to be implanted
Time frame: Pre-operative baseline to 6-months post-activation
Evaluate the change to speech perception using the TICI G2 Clinical Investigation System with invisible hearing (IH) compared with baseline in the ear to be implanted
Time frame: Pre-operative baseline to 6-months post-activation
Evaluate the subjective ratings of hearing ability in the preferred bilateral listening mode
Time frame: Pre-operative baseline to 6-months post-activation
Evaluate the overall health status as measured by the Health Utilities Index (HUI2/3)
Time frame: Pre-operative baseline to 6-months post-activation
Evaluate the impact of the TICI G2 Clinical Investigation System usage on THI ratings
Time frame: Pre-operative baseline to 3-months post-activation
Characterize the device usage over time of TICI G2 Clinical Investigation System
Time frame: Activation to 6-months post-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 26 Oct 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.
Silivi Andrea Borokoski Barriero contact
Angel Ramos Marcias, Prof. Doctor principal investigator
Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria Las Palmas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant in people with Sensorineural Hearing Loss and Tinnitus, run by Cochlear at 1 site in Spain.
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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 26 Oct 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 Spain. 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 Angel Ramos Marcias Prof. Doctor (+34 609564507, ramosorl@idecnet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of the TICI G2 Clinical Investigation System usage on Tinnitus Handicap Inventory (THI) ratings (time frame: Preoperative baseline to 6- months post-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 26 Oct 2026.