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

Summary

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.

Conditions

• Sensorineural Hearing Loss
• Perceived Hearing Loss
• Hearing Impairment

Interventions

DEVICE

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 evaluate the hearing aid's amplification performance. The two RH210 self-test response methods evaluated in this study are: * Detection response method: the participant presses the response control when they hear the tone or beep (Mode A). * Audibility-release response method: the participant maintains the response control while the tone or beep is audible and releases the response control when they no longer hear the tone or beep (Mode B).

PROCEDURE

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.

Sponsors & Collaborators

• Global Edge Medtech Consulting

  collaborator UNKNOWN

• National Acoustic Laboratories

  collaborator UNKNOWN

• Rehear Audiology Company LTD

  lead INDUSTRY

Principal Investigators

• Bettina Turnbull, Doctor of Audiology · National Acoustic Laboratories

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-15

Primary Completion

2026-10-01

Completion

2026-10-01

Countries

• Australia

Study Locations