Hearing ImpairmentNCT07100522
Clinical Evaluation of the Nuance Audio Hearing Aid in Adults With Mild to Moderate Hearing Difficulties
A study testing Hearing aid in spectacle frame form factor and hearing aid in people with Hearing Impairment, run by Luxottica Group S.p.A. at 1 site in Australia.
Trial summary
The research will produce clinical effectiveness performance metrics using standardised procedures of the Nuance Audio hearing device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Hearing aid in spectacle frame form factor and hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jun 2025to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
National Acoustic Laboratories
Macquarie Park, New South Wales, 2109
About this study
The research will produce clinical effectiveness performance metrics using standardised procedures of the Nuance Audio hearing device.
Read the 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
- Being tested
- Hearing aid in spectacle frame form factor, hearing aid
- Keywords
- Nuance Audio hearing device, speech in noise, hearing difficulties, mild to moderate
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hearing aid in spectacle frame form factor; Device: hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intellegibility testing (Matrix test) with and without device
Conducted in both quiet and noise using validated Australian English BKB sentence materials.
Measured: Day 1
Secondary outcomes (1)
Real-world assessments
Moderated walking tour in various acoustic settings (e.g., quiet rooms, traffic noise, multi-talker babble).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start11 Jun 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- post-market interventional, usability
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxottica Group S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100522
- Sponsor's protocol ID
- C24.08
- Status last verified
- Aug 2025
- First submitted
- 15 May 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Nuance Audio Hearing Aid in Adults With Mild to Moderate Hearing Difficulties
- ClinicalTrials.gov ID
- NCT07100522
- Acronym / sponsor ID
- C24.08
- Conditions
- Hearing Impairment
- Keywords
- Nuance Audio hearing device, speech in noise, hearing difficulties, mild to moderate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Luxottica Group S.p.A.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- post-market interventional, usability
| Arm | Type | Receives |
|---|---|---|
| Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor | Other | Device: Hearing aid in spectacle frame form factor, Device: hearing aidThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aid in spectacle frame form factoreyewear 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 | Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor |
| hearing aidHearing aid in spectacle frame form factor | Device | Clinical performance speech intelligibility with Hearing aid in spectacle frame form factor |
Primary outcome
Speech intellegibility testing (Matrix test) with and without device
Time frame: Day 1
Conducted in both quiet and noise using validated Australian English BKB sentence materials.
1 secondary outcome
Real-world assessments
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid in spectacle frame form factor and hearing aid in people with Hearing Impairment, run by Luxottica Group S.p.A. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech intellegibility testing (Matrix test) with and without device (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.