Hearing Impairment, Sensorineural, Perceived Hearing Loss
Conditions
Brief summary
The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.
Detailed description
The primary objective of this clinical investigation is to demonstrate that the RH210A device provides a clinically meaningful improvement in speech understanding in noise compared with unaided listening in adults with perceived mild-to-moderate hearing loss. Speech-in-noise performance will be assessed using the BKB-SIN (Australian version), which quantifies the change in signal-to-noise ratio required for sentence recognition. The primary endpoint is defined as the within-subject difference between unaided and RH210 conditions (change in SNR = Unaided - RH210). A successful outcome is defined as a mean improvement of equal to or more than 2 dB in SNR with RH210 compared to unaided listening.
Interventions
DEVICEInvestigational device (RH210A)
Over the counter device
DEVICEApple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
FDA cleared OTC device (Control arm)
Sponsors
Rehear Audiology Company LTD
Global Edge Medtech Consulting
National Acoustic Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, controlled, within-subject crossover study designed to evaluate the clinical performance, usability, and safety of the RH210 hearing aid and software in adults with perceived mild-to-moderate hearing loss. The study directly compares the performance of the investigation device with both unaided listening and a legally marketed predicate device Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF) under identical, clinically relevant conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aided vs unaided pure-tone audiogram (PTA) measured in dBSPL | Day 1 (Visit 1) and Day 7 (Visit 2) | Aided audiogram with both the investigational and control device measured at 500, 1000, 2000 and 4000Hz in dBSPL. Compared with unaided audiogram measured at the same frequencies in dBSPL. Measured conducted in the sound field in a sound isolated room with warble tones presented from 0 degrees azimuth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech understanding in background noise (BKB-SIN; AUS) | Day 1 (Visit 1) and Day 7 (Visit 2) | Participants will be asked to perform a speech in noise test. Participants will be presented with speech sentences and asked to recall the words they hear. The target stimuli will comprise of BKB sentences (Australian English version), and the noise will be spatially diffuse speech babble. The noise level will be fixed and the speech level will be adaptively changed (Keidser et al, 2013) to determine the speech reception threshold at 50% in dB SNR recall performance, using phonemic scoring. The test conditions, unaided and aided, will comprise of four repeated measures each, with 32 sentence repeats, conducted at 50% threshold. The order of conditions will be randomized across participant. The device will be set to 'Immersive Conversation' mode. For the AirPods Pro 2, the Hearing Aid setting will be toggled, and the AirPods set in Transparency mode. |
| Real Ear Measure Measurement (REIG) | Day 1 (Visit 1) and Day 7 (Visit 2) | Measurement of the Real Ear Insertion Gain (REIG) for the control and intervention device. Output will be compared with the prescribed NAL-R target values. |
| Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia). | Day 1 (Visit 1) and Day 7 (Visit 2) | Participants will use the to use the devices in a controlled, moderated, 60 minute walk. The walk will cover five key listening environments and : 1. Library (\~40 dBA) very low or no noise 2. Office (\~50 dBA) with low level noise 3. Outdoor parkway (\~55 dBA) with environmental noise 4. Traffic / street (\~70-75 dBA) with traffic noise 5. Café / food court (\~65-70 dBA) with multi-talker babble noise Performance will be evaluated using the Ecological Momentary Assessment (EMA) (NAL Australia). The study participants will provide feedback by selecting a rating on a five-point Likert scale for questions related to subjective impressions for speech intelligibility, listening effort, loudness/comfort and their aided/unaided preference while using the trial device or control device during the moderated walk. |
Countries
Australia
Contacts
CONTACTMarisa Poulos, Master of Audiology
CONTACTSanna Hou, Master of Audiology
PRINCIPAL_INVESTIGATORBettina Turnbull, Doctor of Audiology
National Acoustic Laboratories
Outcome results
None listed