Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit

Официальное название

Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025

Обзор

The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are: * Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience? * Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting? Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience. Participants will: * Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks. * Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed. * Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices. * Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.

Вмешательства

• Устройство Rechargeable behind-the-ear hearing device kit
  This intervention includes the following components: hearing aid, charger, applicable accessories

Первичные конечные точки

• Subjective questionnaire feedback [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (1)

• Hearing in Noise Test (HINT) [Срок оценки: At the end of treatment, after two weeks of device use.]

Критерии участия

Критерии включения

• Adults (aged 18 years or older)
• Current and experienced hearing aid users (actively using hearing aids for at least 3 months)
• Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)
• Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.
• Good understanding (read/write/speak) of the English language.
• Willingness to comply with all study requirements including minimum wear-time (6-8 hrs/day) of binaural BTE(RIC) investigational devices.
• Good overall health including healthy outer ear with no excessive wax/debris.
• Ear canal size/shape must accommodate appropriate fitting of the hearing device.
• Socially engaged participants are a top priority (out \& active socially) who frequently encounter the noisy situations in which the devices are meant to be used.
• Use/ownership of a smartphone to pair hearing aids with for use with phone calls and streaming.
• Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss

Критерии исключения

• Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.
• Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
• Limited ability to describe listening impressions/experiences and the use of the hearing aid.
• Acute tinnitus (<three months after onset).
• Inability to attend scheduled visits (mobility and/or scheduling).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• National Hearing Services Inc — Kitchener
• National Hearing Services Inc — Mississauga

Идентификаторы

NCT: NCT07414329 · SRF-33501 · 401131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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