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

NCT07100522 | Completed

• 1 other identifier: C24.08
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Impairment

Keywords

Nuance Audio hearing device, speech in noise, hearing difficulties; mild to moderate

Outcome Measures

Primary Outcomes (1)

• Speech intellegibility testing (Matrix test) with and without device

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

  Day 1

Secondary Outcomes (1)

• Real-world assessments

  day 1

Other Outcomes (3)

• Self-reported measures

  Day 1

• Self-reported measures

  day 1

• Self-reported measures

  day 1

Study Arms (1)

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.

Device: Hearing aid in spectacle frame form factor; Device: hearing aid

Interventions

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.

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

hearing aid DEVICE

Hearing aid in spectacle frame form factor

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Luxottica Group S.p.A.: lead

Study Sites (1)

National Acoustic Laboratories

Macquarie Park, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: post-market interventional, usability

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: August 3, 2025
• Study Start: June 11, 2025
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

AU (1)