Hearing LossNCT07074769
Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss
A study testing Evaluation of speech-in-noise intelligibility and listening effort in people with Hearing Loss, run by Luxottica Group S.p.A. at 1 site in Canada.
Trial summary
Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Evaluation of speech-in-noise intelligibility and listening effort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 23 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
- Adults aged 18 years and older
- symmetrical bilateral mild to moderate sensorineural hearing loss
- native speakers of English.
Who cannot join
- Children
- those without hearing loss
- those without symmetrical bilateral mild to moderate sensorineural hearing loss
- those who do not wish to wear the test device instead of their own spectacles during the in-lab procedure
- those who are not native speakers of English
- those who have pacemakers, other implantable devices, or insulin pumps
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-Lab Evaluation of A Hearing Aid Housed in Ophthalmic Spectacles for Mild to Moderate Hearing Loss
Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.
Read the detailed description
This primary objective is to evaluate whether the device improves speech recognition in noise compared to the clinically relevant comparison condition of no treatment (unaided) for adults with mild to moderate hearing loss. The primary outcome will be measured using a clinically available test of speech recognition in noise that uses adaptive bracketing of signal to noise ratio (the Matrix test). The secondary outcome will also assess speech recognition in babble at ecologically valid fixed signal to babble ratios (The Connected Speech Test). Tertiary outcomes will examine device users' ratings of listening effort in noise with and without the device.
- Conditions
- Hearing Loss
- Being tested
- Evaluation of speech-in-noise intelligibility and listening effort
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of speech-in-noise intelligibility and listening effortDevice
The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire
| Study group | Role | What they receive |
|---|---|---|
| A prospective in-lab within-subjects design with repeated measures | Experimental | Test of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device. Receives: Device: Evaluation of speech-in-noise intelligibility and listening effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaided and Aided speech in noise Matrix test
Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR
Measured: 1 hour
Unaided and Aided Connected speech-in-noise tests
Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated
Measured: 1 hour
Secondary outcomes (1)
Unaided vs Aided Ratings of Listening Effort
Evaluation of the listening effort with and without device trough questionnaire
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start23 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 LossStudies 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
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxottica Group S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074769
- Sponsor's protocol ID
- Protocol version 4 9.6.2025
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- In-Lab Evaluation of A Hearing Aid Housed in Ophthalmic Spectacles for Mild to Moderate Hearing Loss
- ClinicalTrials.gov ID
- NCT07074769
- Acronym / sponsor ID
- Protocol version 4 9.6.2025
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Luxottica Group S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- University of Western Ontario, Canada
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 20 Jul 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.
Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.
Detailed description
This primary objective is to evaluate whether the device improves speech recognition in noise compared to the clinically relevant comparison condition of no treatment (unaided) for adults with mild to moderate hearing loss. The primary outcome will be measured using a clinically available test of speech recognition in noise that uses adaptive bracketing of signal to noise ratio (the Matrix test). The secondary outcome will also assess speech recognition in babble at ecologically valid fixed signal to babble ratios (The Connected Speech Test). Tertiary outcomes will examine device users' ratings of listening effort in noise with and without the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A prospective in-lab within-subjects design with repeated measures | Experimental | Device: Evaluation of speech-in-noise intelligibility and listening effortTest of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- symmetrical bilateral mild to moderate sensorineural hearing loss
- native speakers of English.
Key exclusion criteria (6 listed)
- Children
- those without hearing loss
- those without symmetrical bilateral mild to moderate sensorineural hearing loss
- those who do not wish to wear the test device instead of their own spectacles during the in-lab procedure
- those who are not native speakers of English
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 |
|---|---|---|
| Evaluation of speech-in-noise intelligibility and listening effortThe speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire | Device | A prospective in-lab within-subjects design with repeated measures |
Primary outcome
Unaided and Aided speech in noise Matrix test
Time frame: 1 hour
Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR
Unaided and Aided Connected speech-in-noise tests
Time frame: 1 hour
Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated
1 secondary outcome
Unaided vs Aided Ratings of Listening Effort
Time frame: 30 minutes
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.
- Individual participant dataSharing planned: No
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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 Evaluation of speech-in-noise intelligibility and listening effort in people with Hearing Loss, run by Luxottica Group S.p.A. at 1 site in Canada.
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 3 inclusion and 6 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 Canada. 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?
Unaided and Aided speech in noise Matrix test (time frame: 1 hour). The study lists 2 primary outcomes in all. 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.