Clinical Evaluation of the RH210 Hearing Aid

Официальное название

Clinical Evaluation of the RH210 Hearing Aid Software Used With RH210A Device in Adults With Perceived Mild-to-Moderate Hearing Loss

Обзор

The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.

Подробное описание

The primary objective of this clinical investigation is to demonstrate that the RH210A device provides a clinically meaningful improvement in speech understanding in noise compared with unaided listening in adults with perceived mild-to-moderate hearing loss.

Speech-in-noise performance will be assessed using the BKB-SIN (Australian version), which quantifies the change in signal-to-noise ratio required for sentence recognition. The primary endpoint is defined as the within-subject difference between unaided and RH210 conditions (change in SNR = Unaided - RH210). A successful outcome is defined as a mean improvement of equal to or more than 2 dB in SNR with RH210 compared to unaided listening.

Вмешательства

• Устройство Investigational device (RH210A)
  Over the counter device
• Устройство Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
  FDA cleared OTC device (Control arm)

Первичные конечные точки

• Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL [Срок оценки: Day 1 (Visit 1) and Day 7 (Visit 2)]

Вторичные конечные точки (3)

• Speech understanding in background noise (BKB-SIN; AUS) [Срок оценки: Day 1 (Visit 1) and Day 7 (Visit 2)]
• Real Ear Measure Measurement (REIG) [Срок оценки: Day 1 (Visit 1) and Day 7 (Visit 2)]
• Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia). [Срок оценки: Day 1 (Visit 1) and Day 7 (Visit 2)]

Критерии участия

Критерии включения

• Age 18 years
• Self-perceived mild-to-moderate hearing difficulties/ hearing loss
• Competent smartphone use (able to complete self-fitting via the app)
• Able and willing to provide informed consent
• HHIA screening consistent with perceived hearing difficulty
• Willingness and ability to attend two in-person research appointments
• Ability to operate a SmartPhone

Критерии исключения

• Conductive or mixed hearing loss
• Occluding cerumen
• Otologic disease/ active ear pathology
• Severe or profound hearing loss (PTA >S0dBHL) (WHO, 2021)
• Presence of (red-flag) conditions relevant to OTC hearing aid use (per 21 CFR 801.421)
• Visible deformity of the ear (congenital or traumatic).
• Fluid, pus, or blood coming from the ear (e.g., active drainage).
• Sudden or rapidly progressive hearing loss within the recent past (often defined as within \~90 days).
• Any acute or chronic dizziness or vertigo associated with hearing issues.
• Pain or discomfort in or around the ear.
• Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.
• Unilateral hearing loss of sudden onset or large asymmetry between ears.
• Audiometric air-bone gap suggestive of possible conductive pathology (e.g., gap equal or more than 15 dB at key frequencies)
• Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.
• Unilateral hearing loss of sudden onset or large asymmetry between ears

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• National Acoustic Laboratories — Macquarie Park

Идентификаторы

NCT: NCT07572357 · NAL C26.02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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