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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Over the counter device
FDA cleared OTC device (Control arm)
National Acoustic Laboratories
Macquarie Park, New South Wales, Australia
RECRUITINGAided vs unaided pure-tone audiogram (PTA) measured in dBSPL
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.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Speech understanding in background noise (BKB-SIN; AUS)
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.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Real Ear Measure Measurement (REIG)
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.
Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)
Moderated walk to evaluate simulated "real world benefit" (Ecological Momentary Assessment (EMA): NAL Australia).
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.
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Time frame: Day 1 (Visit 1) and Day 7 (Visit 2)