NCT07100522

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Luxottica Group S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The research will produce clinical effectiveness performance metrics using standardised procedures of the Nuance Audio hearing device.

Detailed description

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.

Conditions

• Hearing Impairment

Interventions

Type	Name	Description
DEVICE	Hearing aid in spectacle frame form factor	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.
DEVICE	hearing aid	Hearing aid in spectacle frame form factor

Timeline

• Start date: 2025-06-11
• Primary completion: 2025-08-28
• Completion: 2025-08-28
• First posted: 2025-08-03
• Last updated: 2025-09-05

Locations

1 site across 1 country: Australia