Clinical Evaluation of the RH210 Hearing Aid

Aided 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.

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.

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.

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.

Usability of RH210 using the System Usability Survey (SUS: NAL)

Assess the subjective usability of the RH210 hearing aid software and application workflow in real-world use using the System Usability Survey (SUS) from the National Acoustic Laboratory (NAL). This is to gather data for a proposed human factors evaluation. The scoring is * Poor: Scores below 51 are considered poor. * Average Score: 68. * Above Average: \> 68. * Below Average: \< 68. * Good/Excellent: Scores over 79 are considered good, while 80.3 or higher is an A grade.