Tinnitus Patient Preferences Survey

April 7, 2026 updated by: Nicolas Gninenko

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Neurosoft Bielectronics US Inc.
        • Contact:
        • Principal Investigator:
          • Nicolas Gninenko, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (over 18 years old) with chronic, subjective severe tinnitus

Description

Inclusion criteria:

  • Individuals aged 18 or older suffering from subjective tinnitus
  • Self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus

Exclusion criteria:

  • Individuals under 18 years of age
  • Healthy volunteers without tinnitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with tinnitus
Other: Survey using a questionnaire.
patients preferences survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability preferences for implantable neuromodulation systems for chronic tinnitus
Time Frame: 1 year
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.
1 year
Willingness and ability to pay for novel invasive neuromodulation solutions for chronic tinnitus
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolas Gninenko

Investigators

  • Principal Investigator: Nicolas Gninenko, PhD, Neurosoft Bioelectronics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEP-03301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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