Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss

Официальное название

Clinical Evaluation of Two Rehear RH210 Self-Assessment Methods for Generating NAL-R-Based Prescribed Gain Compared With Conventional Audiometry in Adults With Perceived Mild-to-Moderate Hearing Loss

Обзор

The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are: 1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method. 2. Determine whether either self-assessment response method provides acceptable estimated audibility. 3. Evaluate participant preference between the detection response method and the audibility-release response method. Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement. Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.

Подробное описание

The purpose of this clinical investigation is to evaluate two RH210 hearing aid software self-assessment response methods used to generate NAL-R-based prescribed gain for adults with perceived mild-to-moderate hearing loss. The study will compare prescribed gain outputs derived from each RH210 self-assessment response method with prescribed gain outputs derived from conventional audiometry using the same NAL-R prescription approach. The study will also assess whether the resulting prescribed gain provides estimated audibility using Speech Intelligibility Index (SII) analysis, and will evaluate participant preference between the two self-assessment response methods. The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss.

The two RH210 self-assessment response methods evaluated in this study are:

1. Detection response method (Option 1): the participant presses a response control when they hear the tone or beep. 2. Audibility-release response method (Option 2): the participant maintains a press while the tone or beep is audible and releases the response control when they no longer hear it.

The study is designed to:

1. Evaluate agreement between NAL-R prescribed gain outputs generated from conventional audiometry and NAL-R prescribed gain outputs generated from each RH210 self-assessment response method. 2. Compare the detection response method and audibility-release response method with respect to prescribed gain agreement by ear and frequency. 3. Assess estimated audibility associated with the self-assessment-derived NAL-R prescriptions using Speech Intelligibility Index (SII) analysis. 4. Determine whether either self-assessment response method provides acceptable estimated audibility, including in cases where prescribed gain does not exactly match the conventional-audiometry-derived NAL-R prescription. 5. Evaluate participant preference between the detection response method and the audibility-release response method. 6. Assess general agreement, completeness, invalid-test rate, usability and response consistency for each self-assessment response method. 7. Support validation of the Rehear assessment-to-fitting pathway without positioning the RH210 self-assessment function as a diagnostic audiometer.

This study is not intended to establish Human Factors performance. However, observations arising during execution of the assessment workflow may identify opportunities to improve the user interface, workflow or user guidance before the final Human Factors validation study. These observations are exploratory development outputs and are not formal study endpoints.

Вмешательства

• Устройство OTC Hearing Aid Self Fitting App
  The Investigational Medical Device (IMD) consists of the RH210 hearing aid software self-test function accessed through the Rehear smartphone application and used in combination with the RH210A compatible in-ear hardware platform. For this clinical investigation, the RH210A hardware platform is used to present calibrated test sounds (pure tones) to the participant during the app-based self-test. The RH210A is not being evaluated as a diagnostic audiometer, and the study is not designed to evalu
• Процедура Audiometry
  The comparator for this clinical investigation is conventional manual pure-tone audiometry performed in accordance with ANSI/ASA S3.21-2004 (R2023), Methods for Manual Pure-Tone Threshold Audiometry, followed by generation of a NAL-R-based prescribed gain output.

Первичные конечные точки

• Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions [Срок оценки: Day 1]

Вторичные конечные точки (2)

• Difference in Speech Intelligibility Index (SII) and SRT in quiet (CNC words) between the three conditions [Срок оценки: Day 1]
• Number of Participants with Treatment-Related Adverse Events as classified by ISO14155:2026 [Срок оценки: Day 1]

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 исключения

\-

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

Австралия · 1 центр

• National Acoustic Laboratories — Macquarie Park

Идентификаторы

NCT: NCT07738237 · NAL C26.08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗