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

NCT ID: NCT07100522

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2025-08-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor

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.

Group Type: OTHER

Hearing aid in spectacle frame form factor

Intervention Type: 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.

hearing aid

Intervention Type: DEVICE

Hearing aid in spectacle frame form factor

Interventions

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.

Intervention Type: DEVICE

hearing aid

Hearing aid in spectacle frame form factor

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luxottica Group S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Acoustic Laboratories

Macquarie Park, New South Wales, Australia

Countries

Australia

Other Identifiers

C24.08

Identifier Type: -

Identifier Source: org_study_id