Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss

Обзор

The goal of this clinical trial will be to evaluate the efficacy of artificial intelligence-integrated hearing aids in individuals with hearing loss. The main questions to answer are: 1. How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise. 2. How does an artificial intelligence integrated hearing aid compare to currently available commercial hearing aids.

Подробное описание

Hearing loss is a leading cause of disability globally. Undertreated hearing loss has been associated with several deleterious sequelae, including social isolation, decreased quality of life, and cognitive decline. For a large portion of individuals with hearing loss, hearing aids remain the intervention of choice for improving communication, decreasing social isolation, and enhancing quality of life. Yet, less than 20% of hearing aid candidates choose to use them2. This is partly due to a perceived lack of benefit from hearing aids. Individuals who use hearing aids continue to report difficulty with speech perception in noisy environments with multiple speakers, such as parties, restaurants, and other complex auditory settings.

The investigators have developed a neural network that runs on-device to achieve real-time target speech hearing in realistic multi-talker environments. Using our neural network, the wearer can focus on speech from a target speaker by learning their unique speech cues while ignoring all interfering speech and noise in complex acoustic environments. The wearer is additionally able to use distance to separate sounds from the environment from target sounds to be amplified. Finally the wearer is also able to specificy categories of sound that will be amplified in environment.

This study will prospectively study a hearing aid implementing these algorithms on individuals with hearing loss. Participants will be randomized to utilizing one of two commercial hearing aids vs the experimental device. Participants will participate in listening tests in which they must identify the words spoken by a specific voice in multi-talker babble noise. The investigators will measure performance with the primary and secondary outcome measures listed elsewhere.

Вмешательства

• Устройство Artificial Intelligence Integrated Hearing Aid Use
  Participants in this arm will use the study-designed artificial intelligence-integrated hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls.
• Устройство Phonak Infineo Hearing Aid
  Participants in this arm will use a fitted commercial hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls.
• Устройство Oticon Real Hearing Aid
  Participants in this arm will use a fitted commercial hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls.

Первичные конечные точки

• Speech Reception Threshold [Срок оценки: From enrollment in the study until completion of a one day listening test experiment.]
• Awareness of Environmental Marker [Срок оценки: From enrollment in the study until completion of a one day listening test experiment.]

Вторичные конечные точки (2)

• Preference Scores [Срок оценки: From enrollment in the study until completion of a one day listening test experiment.]
• Sound quality [Срок оценки: 5 minutes]

Критерии участия

Критерии включения

• Minimum Age of 18 yo
• Bilateral sensorineural hearing loss amenable to hearing aids
• Able to give informed consent
• Native English speaker
• Able to wear a standard pair of hearing aids

Критерии исключения

• Unable to participate in informed consent
• Use of a cochlear implant
• Hearing loss not amenable to hearing aid use
• Conductive hearing loss

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06792110 · STUDY00018443

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗