Hearing Loss MixedPhase 2/3NCT07282028
A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
A Phase 2/3 study testing Spectacle Hearing Aid in people with Hearing Loss Mixed, run by Nuance Hearing at 1 site in Israel.
Trial summary
Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss Mixed
- What is being tested?
- Spectacle Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Jul 2025to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Perceived mild to moderate hearing loss as indicated by at least 1 positive answer to any of the signs specified by FDA: a) You have trouble hearing speech in noisy places, b) You find it hard to follow speech in groups, c) You have trouble hearing on the phone. d) Listening makes youtired, e) You need to turn up the volume on the TV or radio, and other people complain it's too loud
- Wearing corrective glasses for daily use
- Cognitive ability to understand and follow study instructions.
- The main language used in social interactions is Hebrew
- Participants must be willing to use the investigational device according to the instructions for use during the study period
- Participants must be able to use a smartphone
Who cannot join
- Hearing loss >55 dB HL
- Prior hearing aid usages for the last 12 months
- Medical history of cognitive or neurological impairment.
- Active inflammatory conditions affecting the ear
- Asymmetric or unilateral hearing loss - more than 15dB between ears in PTA4- based on screening or hearing test from the last 18 months.
- participation in stage 1 study
Show all 12Show fewer
- Congenital ear defect or a deformed or injured ear
- In the past 6 months discharge of blood, pus or fluid
- Wax that might disturb REM test
- Sudden hearing loss in the past 6 months
- Wearer of electromagnetic medical device
- Other medical conditions/medications that would interfere with subject safety or data collection in the opinion of the PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Asssuta ramat hachayal
Tel Aviv
Weesam Watad, MD, 972-502775099, wwatad@gmail.com
About this study
Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy
Read the detailed description
Screening Written informed consent must be obtained for each study subject prior to the commencement of the study. Upon verification of eligibility and execution of informed consent, subjects will be assigned a study code.
The study comprises two groups, stage 1 will include up to 30 participants. Stage 2 will include up to 29 participants. Stage 1 will be conducted before Stage 2, and individuals enrolled in Stage 1 will not be eligible to participate in Stage 2. The eligibility criteria for each group are outlined below.
Screening procedures include:
- ICF signature and process
- Eligibility Assessment
- Data collection: such as Age, Gender, demographic, ENT medical History
- Otoscopy performed by ENT physician
- Audiometry (Air conduction and bone conduction thresholds) might be performed as part of any other test day.
- Spectacle Hearing Aid calibration and Fitting (this activity is subjected to test with Spectacle Hearing Aid ).
- REM, aided only (optional) might be performed as part of any other test day.
- Optometrist- for glasses prescription (stage 2 only) Stage 1 :This stage involves hearing evaluation tests , which will be conducted over up to four visits, depending on participant cooperation. Each visit will be scheduled on consecutive days or up to 3 weeks apart, based on the participant's and study staff availability.
Stage 2 : After completing the screening visit, each participant will attend two additional visits. At the enrollment visit, participants will receive their Spectacle Hearing Aid along with the prescribed lenses. They will undergo training using the device and will be asked to fill out questionnaires and performed hearing tests. Additionally, the device application and Electronic Patient-Reported Outcome (ePRO) will be installed on the participants' smartphones, and a demonstration will be provided. Participants will then be required to complete the ePRO daily until the study concludes. Functional auditory test battery will be conducted. Few weeks later, participants will return to complete questionnaires.
- Conditions
- Hearing Loss Mixed
- Being tested
- Spectacle Hearing Aid
- Keywords
- hearing aid, hearing disability
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle Hearing AidDevice
wearing hearing aid for effectiveness assessment by hearing tests and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Spectacle Hearing Aid Receives: Device: Spectacle Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectacle Hearing Aid effectiveness
Difference in SNR-50 when performed unaided versus aided using Spectacle Hearing Aid
Measured: 2 weeks
Spectacle Hearing Aid safety
Incidence of device or procedure related adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start27 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss MixedStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuance Hearing
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assuta Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282028
- Sponsor's protocol ID
- 82CLD
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for confidentiality reasons
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy
- ClinicalTrials.gov ID
- NCT07282028
- Acronym / sponsor ID
- 82CLD
- Conditions
- Hearing Loss Mixed
- Keywords
- hearing aid, hearing disability
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Nuance HearingIndustry (pharma, biotech, devices)
- Collaborators
- Assuta Medical Center
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Dec 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.
Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy
Detailed description
Screening Written informed consent must be obtained for each study subject prior to the commencement of the study. Upon verification of eligibility and execution of informed consent, subjects will be assigned a study code.
The study comprises two groups, stage 1 will include up to 30 participants. Stage 2 will include up to 29 participants. Stage 1 will be conducted before Stage 2, and individuals enrolled in Stage 1 will not be eligible to participate in Stage 2. The eligibility criteria for each group are outlined below.
Screening procedures include:
- ICF signature and process
- Eligibility Assessment
- Data collection: such as Age, Gender, demographic, ENT medical History
- Otoscopy performed by ENT physician
- Audiometry (Air conduction and bone conduction thresholds) might be performed as part of any other test day.
- Spectacle Hearing Aid calibration and Fitting (this activity is subjected to test with Spectacle Hearing Aid ).
- REM, aided only (optional) might be performed as part of any other test day.
- Optometrist- for glasses prescription (stage 2 only) Stage 1 :This stage involves hearing evaluation tests , which will be conducted over up to four visits, depending on participant cooperation. Each visit will be scheduled on consecutive days or up to 3 weeks apart, based on the participant's and study staff availability.
Stage 2 : After completing the screening visit, each participant will attend two additional visits. At the enrollment visit, participants will receive their Spectacle Hearing Aid along with the prescribed lenses. They will undergo training using the device and will be asked to fill out questionnaires and performed hearing tests. Additionally, the device application and Electronic Patient-Reported Outcome (ePRO) will be installed on the participants' smartphones, and a demonstration will be provided. Participants will then be required to complete the ePRO daily until the study concludes. Functional auditory test battery will be conducted. Few weeks later, participants will return to complete questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Spectacle Hearing AidSpectacle Hearing Aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years and older
- Perceived mild to moderate hearing loss as indicated by at least 1 positive answer to any of the signs specified by FDA: a) You have trouble hearing speech in noisy places, b) You find it hard to follow speech in groups, c) You have trouble hearing on the phone. d) Listening makes youtired, e) You need to turn up the volume on the TV or radio, and other people complain it's too loud
- Wearing corrective glasses for daily use
- Cognitive ability to understand and follow study instructions.
- The main language used in social interactions is Hebrew
Key exclusion criteria (12 listed)
- Hearing loss >55 dB HL
- Prior hearing aid usages for the last 12 months
- Medical history of cognitive or neurological impairment.
- Active inflammatory conditions affecting the ear
- Asymmetric or unilateral hearing loss - more than 15dB between ears in PTA4- based on screening or hearing test from the last 18 months.
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 |
|---|---|---|
| Spectacle Hearing Aidwearing hearing aid for effectiveness assessment by hearing tests and questionnaires | Device | Active |
Primary outcome
Spectacle Hearing Aid effectiveness
Time frame: 2 weeks
Difference in SNR-50 when performed unaided versus aided using Spectacle Hearing Aid
Spectacle Hearing Aid safety
Time frame: 2 weeks
Incidence of device or procedure related adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No. for confidentiality reasons
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Spectacle Hearing Aid in people with Hearing Loss Mixed, run by Nuance Hearing at 1 site in Israel.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Dec 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 Israel. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yael Corcos, MPH (972-54-8106010, yael@ay-impact.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectacle Hearing Aid effectiveness (time frame: 2 weeks). 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 15 Dec 2025.