Набор скоро начнётся NCT07711249

Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium

— Наблюдательное Tinnitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Sonova manufactured hearing aids with built-in Tinnitus feature.
Кому может быть актуально: Состояния в реестре: Tinnitus. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Список центров уточняется — проверьте первичный протокол.
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Tinnitus, the perception of sound without an external source, affects around 15% of the global adult population (Jarach et al., 2022). For many, tinnitus is a mild annoyance, but a significant subset experiences severe distress, leading to reduced quality of life and increased healthcare burden. Hearing loss is a major risk factor for tinnitus (Biswas et al., 2023), and clinical guidelines recommend hearing aids as a therapeutic option (Langguth et al., 2023). In addition to amplification through hearing aids, sound therapy has long been used to help manage tinnitus (Sereda \& Hoare, 2024). A recent randomized controlled trial has demonstrated the clinical efficacy of Sonova hearing aids with integrated noise generator (further referred to as "Tinnitus-feature") in reducing tinnitus-related distress. However, the evidence is limited for newer generations of hearing aids and for individuals with severe to profound hearing loss. This study aims to address these gaps by evaluating the clinical benefit of the noise generator feature in newer generations of Sonova hearing aids for adults with tinnitus and hearing loss and in patients with severe to profound hearing loss during routine clinical practice.

Подробное описание

This study is designed to enroll subjects both retrospectively and prospectively. Eligible subjects will be identified and enrolled through the participating clinical site according to the Clinical Investigation Protocol, which was approved by the local Ethics Committee.

Вмешательства

Устройство Sonova manufactured hearing aids with built-in Tinnitus feature
Tinnitus-related annoyance before and after using Sonova manufactured hearing aids with built-in Tinnitus feature. Before use is considered the baseline.

Первичные конечные точки

Tinnitus-related Annoyance [Срок оценки: From enrollment to survey completion, roughly 15 minutes.]

Критерии участия

Критерии включения

Participants ≥ 18 years old
Participants with chronic tinnitus (≥ 6 months)
Participants with the Tinnitus feature activated
Participants that have completed the NRS during routine clinical practice and are at least a little bothered by their tinnitus (NRS ≥ 3)
Participants with at least one Sonova manufactured hearing aid with the tinnitus feature activated for at least 12 weeks