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The research will produce clinical effectiveness performance metrics using standardised procedures of the Nuance Audio hearing device.
EssilorLuxottica is actively pursuing commercialization of their Nuance Audio device in the US (Class 2 - OTC SaMD) and in the EU under the Class IIa classification for hearing aids. The device form factor is an eyeglass frame. Currently there are no medical devices marketed as a hearing aid in the intended form factor (Nuance Audio) which suggests the need for preclinical and clinical evaluations to assess any impact to non-clinical standards compliance and user clinical performance. The manufacturer is actively addressing standards compliance with qualified third-party laboratories and has engaged NAL to collaborate on the clinical assessments based on its extensive history and expertise in the personal hearing aid arena.
Clinical assessment of device performance (basic safety and effectiveness with intended users) will be conducted as per study protocol. Additionally, to ensure quality, preliminary bench top compliance testing will be conducted as part of the study prior to first participant enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor | Other | This study uses a within-subjects design in which participants complete assessments in both unaided and aided conditions, using the Nuance Audio Glasses as the investigational hearing aid device. Each participant attends two sessions at the National Acoustic Laboratories (NAL), with testing conducted in controlled and real-world environments. Research methods include: Audiometric assessments: Pure-tone audiometry, tympanometry, and Real Ear Measurements (REMs). Speech perception testing: Conducted in both quiet and noise using validated Australian English BKB sentence materials. Real-world assessments: Moderated walking tour in various acoustic settings (e.g., quiet rooms, traffic noise, multi-talker babble). Self-reported measures: Questionnaires assessing hearing difficulty (HHIE-S), listening goals (COSI), perceived benefit (IOI-HA), and device preference and satisfaction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid in spectacle frame form factor | Device | eyewear frames embedded with groundbreaking technology which seamlessly integrate an air conduction hearing aid (over-the-counter "OTC", in the United States) intended to amplify sound for adult users (18yrs and older) with a perceived mild to moderate hearing impairment. Nuance Audio Glasses may, if necessary, be used in association with prescription lenses for those adults who also require correction of visual defects. Nuance Audio Glasses can be worn all day and can be easily configured via the App to adapt to any situation, from business meetings to family time. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech intellegibility testing (Matrix test) with and without device | Conducted in both quiet and noise using validated Australian English BKB sentence materials. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world assessments | Moderated walking tour in various acoustic settings (e.g., quiet rooms, traffic noise, multi-talker babble). | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported measures | Questionnaires assessing hearing difficulty (HHIE-S). The outcome measure is the grade of 10 questions ( 0 - 2 or 4 points per each question). | Day 1 |
| Self-reported measures | Questionnaires assessing listening goals (COSI). The outcome measure is the grade in 5 different situation for entity of benefit ( on a scale from 1 to 5) and frequency of the benefit ( on a scale form 1 to 5) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Acoustic Laboratories | Macquarie Park | New South Wales | 2109 | Australia |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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post-market interventional, usability
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|
| hearing aid | Device | Hearing aid in spectacle frame form factor |
|
| day 1 |
| Self-reported measures | Questionnaires assessing perceived benefit (IOI-HA), The outcome measure is the grade to the questionnaire 7 questions on different scale ( raging from 1 to 5). | day 1 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |