Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss

Обзор

Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit over a prolonged duration in a sample of individuals with bilateral hearing loss. It will also compare how long each method takes to make and how much each costs.

Вмешательства

• Устройство BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)
  Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Third-party, FlexResin, Resin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group.
• Устройство BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)
  Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group
• Устройство BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)
  Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group

Первичные конечные точки

• Outer EAR comfort questionnaire [Срок оценки: through study completion, an average of 1 week]
• Real Ear Measures [Срок оценки: through study completion, an average of 1 week]

Вторичные конечные точки (2)

• Cost [Срок оценки: through study completion, an average of week]
• Time [Срок оценки: through study completion, an average of week]

Критерии участия

Критерии включения

• Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss
• Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
• English speaking.

Критерии исключения

• Self reported history of extensive or current outer or middle ear pathology.
• Self reported history of extensive outer or middle ear surgery.
• Self reported history of neurological or cognitive disorder.
• Active ear infection

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Arizona Hearing Clinic — Tucson

Идентификаторы

NCT: NCT07228845 · 5737

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗