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

Overview

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.

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.