Tinnitus, SubjectiveNCT06782308
Tinnitus Patient Preferences Survey
An observational study of Tinnitus, Subjective and Tinnitus, Bilateral, run by Nicolas Gninenko at 1 site in United States.
Trial summary
The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced
- What is being tested?
- Survey using a questionnaire.
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 3 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
Study population: Adult patients (over 18 years old) with chronic, subjective severe tinnitus
Who may be able to join
- Individuals aged 18 or older suffering from subjective tinnitus
- Self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus
Who cannot join
- Individuals under 18 years of age
- Healthy volunteers without tinnitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurosoft Bielectronics US Inc.
New York, New York, 10016
About this study
The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). This survey covers the acceptance of a surgically-placed brain implant, of its associated risks related to the neurosurgical procedure, usability considerations, and the willingness/ability to pay for such a treatment.
Neurosoft Bioelectronics will use the collected patients' feedback and usability preferences data for the development of a novel minimally invasive brain implant aimed at alleviating tinnitus.
Read the detailed description
Neurosoft Bioelectronics is developing a minimally invasive implantable solution for the treatment of chronic, subjective moderate-to-severe cases of tinnitus. The approach involves developing a state-of-the-art neurostimulation paradigm and incorporating invasive neuromodulation findings from leading experts in the field to create an effective solution. This solution aims to minimize patient's burden by offering a fully implantable system that does not require active patient engagement or repetitive adjustments of electrical stimulation parameters. Instead, it will use a closed-loop feedback algorithm, that will be optimized through multi-target recordings and stimulation, to continuously adapt and refine the treatment. This type of solution could significantly increase the quality of life of affected individuals living with severe chronic tinnitus, for which only palliative and symptom management solutions exist today. As Neurosoft Bioelectronics is at the early stage of device development, we will use the collected patients' feedback and usability preferences data for refining clear users' and product's requirements.
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced, Tinnitus, Hearing Loss, Cochlear Implant Users
- Being tested
- Survey using a questionnaire.
- Keywords
- tinnitus, iBCI, brain implant, survey, risks acceptance, user preferences, patient preferences, subjective tinnitus, chronic tinnitus, severe tinnitus, catastrophic tinnitus, invasive neuromodulation, surgical treatment
- Medical subject headings
- Tinnitus, Hearing Loss, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
patients preferences survey
| Study group | Role | What they receive |
|---|---|---|
| patients with tinnitus | Not described Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of invasive neuromodulation treatments for chronic tinnitus
Risks acceptance and user preferences will be assessed through responses to the survey. The outcome will be summarized in the form of a percentage or similar statistics on acceptances rates for surgical interventions in patients with chronic tinnitus. Acceptance rates will also be evaluated in accordance to several clinical characteristics of tinnitus, such as its perceived annoyance or loudness.
Measured: 1 year
Secondary outcomes (2)
Usability preferences for implantable neuromodulation systems for chronic tinnitus
Usability preferences will be assessed through responses to the survey. This secondary outcome will be summarized in the form of a percentage or similar statistics on usability preferences between different solutions involving surgical interventions in patients with chronic tinnitus. Usability preferences will also be evaluated with respect to different reported tinnitus characteristics, such as perceived annoyance or loudness.
Measured: 1 year
Willingness and ability to pay for novel invasive neuromodulation solutions for chronic tinnitus
Willingness to pay (WTP) will be assessed through responses to the survey. This secondary outcome will be summarized in the form of a range ($ US) or similar statistics on willingness and ability to pay with respect to different solutions involving surgical interventions in patients with chronic tinnitus. WTP will also be evaluated with respect to different reported tinnitus characteristics, such as perceived annoyance or loudness.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Jan 2025
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nicolas Gninenko
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Nicolas Gninenko, Neurosoft Bioelectronics SA
- Investigators
- Nicolas Gninenko, PhD, Principal investigator, Neurosoft Bioelectronics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782308
- Sponsor's protocol ID
- TEP-03301
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus Patient Preferences Survey
- ClinicalTrials.gov ID
- NCT06782308
- Acronym / sponsor ID
- TEP-03301
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced, Tinnitus, Hearing Loss, Cochlear Implant Users
- Keywords
- tinnitus, iBCI, brain implant, survey, risks acceptance, user preferences, patient preferences, subjective tinnitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Nicolas GninenkoIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 17 Jan 2025 (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 goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). This survey covers the acceptance of a surgically-placed brain implant, of its associated risks related to the neurosurgical procedure, usability considerations, and the willingness/ability to pay for such a treatment.
Neurosoft Bioelectronics will use the collected patients' feedback and usability preferences data for the development of a novel minimally invasive brain implant aimed at alleviating tinnitus.
Detailed description
Neurosoft Bioelectronics is developing a minimally invasive implantable solution for the treatment of chronic, subjective moderate-to-severe cases of tinnitus. The approach involves developing a state-of-the-art neurostimulation paradigm and incorporating invasive neuromodulation findings from leading experts in the field to create an effective solution. This solution aims to minimize patient's burden by offering a fully implantable system that does not require active patient engagement or repetitive adjustments of electrical stimulation parameters. Instead, it will use a closed-loop feedback algorithm, that will be optimized through multi-target recordings and stimulation, to continuously adapt and refine the treatment. This type of solution could significantly increase the quality of life of affected individuals living with severe chronic tinnitus, for which only palliative and symptom management solutions exist today. As Neurosoft Bioelectronics is at the early stage of device development, we will use the collected patients' feedback and usability preferences data for refining clear users' and product's requirements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with tinnitus | – | Other: Survey using a questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (over 18 years old) with chronic, subjective severe tinnitus
Key inclusion criteria (2 listed)
- Individuals aged 18 or older suffering from subjective tinnitus
- Self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus
Key exclusion criteria (2 listed)
- Individuals under 18 years of age
- Healthy volunteers without tinnitus
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 |
|---|---|---|
| Survey using a questionnaire.patients preferences survey | Other | patients with tinnitus |
Primary outcome
Acceptance of invasive neuromodulation treatments for chronic tinnitus
Time frame: 1 year
Risks acceptance and user preferences will be assessed through responses to the survey. The outcome will be summarized in the form of a percentage or similar statistics on acceptances rates for surgical interventions in patients with chronic tinnitus. Acceptance rates will also be evaluated in accordance to several clinical characteristics of tinnitus, such as its perceived annoyance or loudness.
2 secondary outcomes
Usability preferences for implantable neuromodulation systems for chronic tinnitus
Time frame: 1 year
Willingness and ability to pay for novel invasive neuromodulation solutions for chronic tinnitus
Time frame: 1 year
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 9 Sep 2026.
- Related InfoLink provided by the sponsor.
- Link to access the surveyLink 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.
Nicolas Gninenko, PhD principal investigator
Neurosoft Bioelectronics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, Subjective and Tinnitus, Bilateral, run by Nicolas Gninenko 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 2 inclusion and 2 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 9 Sep 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?
Acceptance of invasive neuromodulation treatments for chronic tinnitus (time frame: 1 year). 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 9 Sep 2026.