Clinical Evaluation of the Nuance Audio Hearing Aid in Adults With Mild to Moderate Hearing Difficulties

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.

Inclusion criteria

• Native English speakers
• Self-reported hearing or listening difficulties
• No need for prescription lenses (contact lenses acceptable)
• Ability to use smartphones and complete online surveys
• Willingness and ability to attend two in-person research appointments

Exclusion criteria

• Active ear disease, occluding cerumen, or any of the FDA "red flag" conditions
• Hearing asymmetry or sudden hearing changes
• Requirement for prescription eyewear (due to device form factor)