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

アクティブコンパレータ：Conventional manual pure-tone audiometry

手順：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.

実験的：Mode A

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

デバイス：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).

実験的：Mode B

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

デバイス：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).

Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions

The primary endpoint is the agreement of NAL-R prescribed gain outputs (dB), by ear (R/L) and frequency (Hz), between:

• Conventional-audiometry-derived NAL-R prescribed gain (dB), and
• RH210 self-test-derived NAL-R prescribed gain (dB), 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).

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

The secondary safety objective is to assess the safety of participant exposure to the RH210 app-based self-test procedure when the RH210A in-ear hardware platform is used to present test sounds.

Safety will be assessed by the incidence, severity, seriousness and relationship to the investigational device or study procedure of:

• adverse events;
• adverse device effects;
• anticipated adverse device effects;
• discomfort associated with in-ear device use;
• excessive loudness or sound intolerance;

No formal statistical hypothesis is proposed for safety. Safety outcomes will be summarized descriptively.

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

The secondary objective is to evaluate whether RH210 self-test-derived NAL-R prescribed gain outputs (dB) provide estimated audibility comparable to the conventional-audiometry-derived NAL-R reference pathway.

The secondary endpoint is the difference in Speech Intelligibility Index / Audibility Index and SRT in quiet between:

(1) The conventional-audiometry-derived NAL-R prescribed gain condition (dB); and (2) Each RH210 self-test-derived NAL-R prescribed gain (dB) condition.

The analysis will be conducted under a pre-specified standard aided speech condition (SRT50% dB), for example adaptive speech in quiet SRT50, with the final method defined in the Statistical Analysis Plan

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

The first exploratory objective is to evaluate participant preference between the two RH210 self-test response methods.

Participant preference will be assessed after completion of both RH210 response methods. The endpoint will include:

• proportion of participants preferring the detection response method;
• proportion preferring the audibility-release response method;
• proportion reporting no preference;
• reasons for preference, where collected. No formal hypothesis is proposed. Results will be summarized descriptively.

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

Exploratory endpoints will include, for each response method:

• completion rate;
• invalid or unusable test rate;
• missing frequency-specific data rate;
• test duration;
• participant-reported ease of use;
• observed difficulty or need for clarification;
• repeatability or response consistency, where repeat data are available.

No formal hypothesis is proposed. Results will be summarized descriptively.