Tinnitus, Bilateral, Tinnitus, Hearing Loss, Cochlear Implant Users, Tinnitus, Noise Induced, Tinnitus, Subjective
Conditions
Keywords
tinnitus, iBCI, brain implant, survey, risks acceptance, user preferences, patient preferences, subjective tinnitus, chronic tinnitus, severe tinnitus, catastrophic tinnitus, invasive neuromodulation, surgical treatment
Brief 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.
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.
Interventions
OTHERSurvey using a questionnaire.
patients preferences survey
Sponsors
Nicolas Gninenko
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of invasive neuromodulation treatments for chronic tinnitus | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability preferences for implantable neuromodulation systems for chronic tinnitus | 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. |
| Willingness and ability to pay for novel invasive neuromodulation solutions for chronic tinnitus | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNicolas Gninenko, PhD
Neurosoft Bioelectronics
Outcome results
None listed