HearingNCT07922187
Speech Recognition With Hearing Enhancement
A study testing Hearing Enhancement in people with Hearing, run by Meta Platforms Technologies LLC at 1 site in United States.
Trial summary
Speech Recognition with Hearing Enhancement in Background Noise Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing
- What is being tested?
- Hearing Enhancement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2026to 28 Oct 2026
- 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
- Have a fully completed and signed informed consent form
- Aged 18 years or older
- Proficient in written and spoken English, defined by self-report
- Mild-to-moderate hearing loss as measured by pure tone audiometry reference test
- Have the ability to read and follow the Health \& Safety Information for the proper wearing and use of the smart glasses, defined by self-report.
Who cannot join
- Normal hearing thresholds, defined as better-ear PTA < 25 dB HL, or better-ear PTA ≥ 60 dB HL
- Conductive hearing loss, defined as an air-bone gap greater than 10 dB at any octave frequency from 500 to 4000 Hz.
- Abnormal Tympanogram (type B, type C, or other) consistent with conductive and/or mixed hearing loss
- Use of a cochlear implant or bone-anchored hearing system
- Ear deformity (either congenital or acquired) not conducive to comfortable wear of glasses
- Obstruction or active drainage from the ear(s), pain or discomfort in the ear(s), or tympanic membrane abnormalities
- Use of prescription glasses that could interfere with study procedures, or current regular use of hearing aids or assistive devices
- In the investigator's opinion, unable to adhere to study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Speech Recognition in Noise With Hearing Enhancement
Speech Recognition with Hearing Enhancement in Background Noise
Read the detailed description
The goal of this clinical study is to assess whether Hearing Enhancement, an over-the-counter, self-fitting hearing aid software that runs on Meta smart glasses, improves the ability to understand speech in background noise in adults with mild to moderate hearing loss.
- Conditions
- Hearing
- Being tested
- Hearing Enhancement
- Keywords
- hearing loss
- 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 EnhancementDevice
Hearing Enhancement is an FDA-cleared (K254044), over-the-counter, self-fitting, air-conduction hearing aid software (SaMD) that runs on Meta smart glasses with a companion smartphone app. Participants complete the in-app self-fitting procedure, and the app programs personalized amplification settings to the glasses. Hearing Enhancement is enabled with the participant's self-fit settings (aided) and is compared with the same glasses worn with Hearing Enhancement turned off (unaided).
| Study group | Role | What they receive |
|---|---|---|
| Hearing Enhancement (aided vs. unaided) | Experimental | Device: Hearing Enhancement Receives: Device: Hearing Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit
Unaided SRT-50 minus aided SRT-50 in dB SNR
Measured: Visit 2, a single test session, within 2 weeks of the screening visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start20 Oct 2026
- Primary completion28 Oct 2026
- Study completion28 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HearingStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meta Platforms Technologies LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Exponent, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922187
- Sponsor's protocol ID
- Pro04233289
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study was conducted by a commercial sponsor to support product development. Aggregate results will be reported on ClinicalTrials.gov at a later date.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Speech Recognition in Noise With Hearing Enhancement
- ClinicalTrials.gov ID
- NCT07922187
- Acronym / sponsor ID
- Pro04233289
- Conditions
- Hearing
- Keywords
- hearing loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Meta Platforms Technologies LLCIndustry (pharma, biotech, devices)
- Collaborators
- Exponent, Inc.
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 28 Oct 2026 (actual)
- Study completion
- 28 Oct 2026 (actual)
- First posted
- 6 Nov 2026 (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.
Speech Recognition with Hearing Enhancement in Background Noise
Detailed description
The goal of this clinical study is to assess whether Hearing Enhancement, an over-the-counter, self-fitting hearing aid software that runs on Meta smart glasses, improves the ability to understand speech in background noise in adults with mild to moderate hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Enhancement (aided vs. unaided) | Experimental | Device: Hearing EnhancementDevice: Hearing Enhancement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a fully completed and signed informed consent form
- Aged 18 years or older
- Proficient in written and spoken English, defined by self-report
- Mild-to-moderate hearing loss as measured by pure tone audiometry reference test
- Have the ability to read and follow the Health \& Safety Information for the proper wearing and use of the smart glasses, defined by self-report.
Key exclusion criteria (8 listed)
- Normal hearing thresholds, defined as better-ear PTA < 25 dB HL, or better-ear PTA ≥ 60 dB HL
- Conductive hearing loss, defined as an air-bone gap greater than 10 dB at any octave frequency from 500 to 4000 Hz.
- Abnormal Tympanogram (type B, type C, or other) consistent with conductive and/or mixed hearing loss
- Use of a cochlear implant or bone-anchored hearing system
- Ear deformity (either congenital or acquired) not conducive to comfortable wear of glasses
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 EnhancementHearing Enhancement is an FDA-cleared (K254044), over-the-counter, self-fitting, air-conduction hearing aid software (SaMD) that runs on Meta smart glasses with a companion smartphone app. Participants complete the in-app self-fitting procedure, and the app programs personalized amplification settings to the glasses. Hearing Enhancement is enabled with the participant's self-fit settings (aided) and is compared with the same glasses worn with Hearing Enhancement turned off (unaided). | Device | Hearing Enhancement (aided vs. unaided) |
Primary outcome
Benefit
Time frame: Visit 2, a single test session, within 2 weeks of the screening visit)
Unaided SRT-50 minus aided SRT-50 in dB SNR
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 6 Nov 2026.
- Individual participant dataSharing planned: No. The study was conducted by a commercial sponsor to support product development. Aggregate results will be reported on ClinicalTrials.gov at a later date.
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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 Enhancement in people with Hearing, run by Meta Platforms Technologies LLC at 1 site in United States.
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 8 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 6 Nov 2026. 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 United States. 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?
Benefit (time frame: Visit 2, a single test session, within 2 weeks of the screening visit)). 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 6 Nov 2026.