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Идёт набор NCT07262827

Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users

Без фазы С лечением Cochlear Implant Users

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: Nucleus 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones, Nucleus 8 Sound Processor streaming via Roger 20, Kanso 3 Sound Processor streaming via Multi-Mic+.
Кому может быть актуально
Состояния в реестре: Cochlear Implant Users. 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
Австралия
Следующий шаг
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Официальное название

A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients

Обзор

This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.

Вмешательства

  • Устройство Nucleus 8 Sound Processor streaming via MultiMic+
    The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory.
  • Устройство Nucleus 8 Sound Processor microphones
    Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2).
  • Устройство Nucleus 8 Sound Processor streaming via Roger 20
    Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory.
  • Устройство Kanso 3 Sound Processor streaming via Multi-Mic+
    Kanso 3 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. This includes the Kanso 3 Nexa Sound Processor.
  • Устройство Kanso 3 Sound Processor microphone
    Kanso 3 Sound Processor streaming audio via the Kanso 3 Sound Processor microphones (SCAN 2). This includes the Kanso 3 Nexa Sound Processor.

Первичные конечные точки

  • Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL [Срок оценки: At ad-hoc visits between enrolment and 12 months]
Вторичные конечные точки (3)
  • Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Nucleus 8 streaming via the Multi-Mic+ and Nucleus 8 streaming via the Roger 20 system at -15 dB SNR in 65 dB SPL [Срок оценки: At ad-hoc visits between enrolment and 12 months]
  • Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Kanso 3 streaming via Multi-Mic+ and Kanso 3 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL [Срок оценки: At ad-hoc visits between enrolment and 12 months]
  • Ratings based on the Device Use Questionnaire after a minimum of two weeks actual-use of the new GN ReSound accessories in the real-world environment [Срок оценки: At ad-hoc visits between enrolment and 12 months]

Критерии участия

Критерии включения

  • Aged 18 years or older
  • Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.
  • At least 3 months experience with a cochlear hearing implant
  • Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.
  • Willingness to participate in and to comply with all requirements of the protocol
  • Fluent speaker in English as determined by the investigator
  • Willing and able to provide written informed consent.

Критерии исключения

  • Additional disabilities that would prevent participation in evaluations
  • Unrealistic expectations on the part of the participant, regarding the possible benefits, risks and limitations that are inherent to the procedures
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  • Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).

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
Другое

Центры проведения

Австралия · 1 центр
  • Cochlear Limited — Sydney

Идентификаторы

NCT: NCT07262827 · CLTD5844

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗