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

NCT07738237 | Not Yet Recruiting

• 1 other identifier: NAL C26.08
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.
2. 2.Determine whether either self-assessment response method provides acceptable estimated audibility.
3. 3.Evaluate participant preference between the detection response method and the audibility-release response method.

Conditions

Sensorineural Hearing Loss; Perceived Hearing Loss; Hearing Impairment

Keywords

OTC Hearing Aid; hearing impairment; hearing aid

Outcome Measures

Primary Outcomes (1)

• Agreement of NAL-R prescribed gain outputs between the comparator conditions

  The primary endpoint is the agreement of NAL-R prescribed gain outputs, by ear and frequency, between: * Conventional-audiometry-derived NAL-R prescribed gain, and * RH210 self-test-derived NAL-R prescribed gain, generated using each of the two RH210 response methods. The frequency-specific analysis will include: 500 Hz; 1 kHz; 2 kHz; and 4 kHz. The two RH210 response methods are: * Detection response method: participant presses when they hear the tone or beep (Mode A). * Audibility-release response method: participant releases the response control when they no longer hear the tone or beep Mode B).

  Day 1

Secondary Outcomes (2)

• Difference in Speech Intelligibility Index (SII) and SRT in quiet (CNC words) between the three conditions

  Day 1

• Number of Participants with Treatment-Related Adverse Events as classified by ISO14155:2026

  Day 1

Other Outcomes (2)

• Participant preference (A vs B questionnaire) will be assessed after completion of both self fit response methods.

  Day 1

• Compare the practical performance of the two RH210 self-test response methods using NAL checklist.

  Day 1

Study Arms (3)

Conventional manual pure-tone audiometry

ACTIVE COMPARATOR

Conventional manual pure-tone audiometry

Procedure: Audiometry

Mode A

EXPERIMENTAL

RH210 self-test method 1: detection response method, where the participant presses when they hear the tone or beep

Device: OTC Hearing Aid Self Fitting App

Mode B

EXPERIMENTAL

RH210 self-test method 2: audibility-release response method, where the participant releases the response control when they no longer hear the tone or beep

Device: OTC Hearing Aid Self Fitting App

Interventions

OTC Hearing Aid Self Fitting App DEVICE

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).

Mode A; Mode B

Audiometry PROCEDURE

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.

Conventional manual pure-tone audiometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rehear Audiology Company LTD: lead
• Global Edge Medtech Consulting: collaborator
• National Acoustic Laboratories: collaborator

Study Sites (1)

National Acoustic Laboratories

Macquarie Park, New South Wales, 2113, Australia

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Interventions

Hearing

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bettina Turnbull, Doctor of Audiology

  National Acoustic Laboratories

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Poulos, Master of Audiology

CONTACT

+61 2 9412 6872; marisa.poulos@nal.gov.au

Sanna Hou, Master of Audiology

CONTACT

+61 2 9412 6872; sann.hou@nal.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)