Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation

Обзор

A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.

Вмешательства

• Устройство Hearing Aid with standard noise reduction (NR_1)
  Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle to mimic the natural directivity of the outer ear.
• Устройство Hearing Aid with NR_2
  Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality
• Устройство Hearing Aid with NR_3
  Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality

Первичные конечные точки

• Own Voice Level [Срок оценки: 3 weeks]

Вторичные конечные точки (2)

• Interpersonal distance [Срок оценки: 3 weeks]
• Qualitative interview form [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• Good written and spoken German language skills
• No suffering from any speech disorders
• Experienced hearing aid user (min. 6 months)
• Ability to stand and walk during the experiment
• Ability to fill in a questionnaire conscientiously
• Ability to produce a reliable hearing test result
• Ability to describe listening experiences/impressions
• The audiogram is in the fitting range of the hearing aid
• The audiogram is in the range of mild to moderate hearing losses (N2 - N4)
• Hearing loss in both ears
• Informed consent form

Критерии исключения

• Contraindications to the medical device
• Unaidable hearing loss in one or both ears
• Acute tinnitus (in either one ear and occurrence for less than 3 months)
• Anatomical deformity of one or both ears
• Single-sided deafness
• Unwillingness to wear the investigational device during the investigational visits
• Active pacemaker implant
• Ear canals are too narrow to take ear impressions
• Ear canals are too narrow for the use of customized earpieces
• Uncomfortable loudness threshold less than 80 dB for at least one measured frequency
• Known hypersensitivity or allergy against synthetic materials
• Acute symptoms of vertigo or dizziness
• Reported Parkinson's disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Sonova AG — Stäfa

Идентификаторы

NCT: NCT06992310 · SRF-30177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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