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

Luxottica Group S.p.A.21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Impairment

Interventions

Hearing aid in spectacle frame form factorDEVICE

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 aidDEVICE

Hearing aid in spectacle frame form factor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

National Acoustic Laboratories

Macquarie Park, New South Wales, Australia

Outcomes

Primary Outcomes

Speech intellegibility testing (Matrix test) with and without device

Conducted in both quiet and noise using validated Australian English BKB sentence materials.

Time frame: Day 1

Secondary Outcomes

Real-world assessments

Moderated walking tour in various acoustic settings (e.g., quiet rooms, traffic noise, multi-talker babble).

Time frame: day 1

Data from ClinicalTrials.gov

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