Tinnitus Patient Preferences Survey

Last updated: January 16, 2025
Sponsor: Nicolas Gninenko
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Hearing Loss

Deafness

Treatment

Survey using a questionnaire.

Clinical Study ID

NCT06782308
TEP-03301
  • Ages > 18
  • All Genders

Study 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). 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Individuals aged 18 or older suffering from subjective tinnitus

  • Self-reported or healthcare professional-diagnosed chronic (lasting 3 months orlonger), subjective, burdensome tinnitus

Exclusion

Exclusion criteria:

  • Individuals under 18 years of age

  • Healthy volunteers without tinnitus

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Survey using a questionnaire.
Phase:
Study Start date:
January 13, 2025
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Neurosoft Bielectronics US Inc.

    New York, New York 10016
    United States

    Active - Recruiting

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