Hearing LossLexieNCT06942325
Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid
A study testing OTC self-fitting hearing aid and Prescription hearing aid in people with Hearing Loss and Hearing Impairment, run by HearX SA.
Trial summary
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption, even in high-income countries with developed audiological services . Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hearing Loss, Hearing Impairment
- What is being tested?
- OTC self-fitting hearing aid and Prescription hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 years or older.
- The outer ear must be free from excessive cerumen, outer or middle ear disease (determined through otoscopic examination of the ear)
- The participant must have bilateral self-perceived mild-moderate hearing loss.
- Baseline pure tone evaluations should fall within a 4-frequency PTA (0.5, 1.0, 2.0, 4.0 kHz) of 65 dB HL or less.
- The participant must have an adequate level of English proficiency as measured objectively using an English proficiency test (EF SET).
- The participant must have Type A or As or Ad tympanogram as measured by tympanometry.
- Must be in possession of a smartphone compatible with the Lexie App (minimum iOS 13 or Android OS 10), preferably within equal distributio
Who cannot join
- Younger than 18 years
- Presents with severe or greater hearing loss in either ear
- Presents with an outer or middle ear abnormality
- Have any of the following as per FDA (21 CFR 801.420) reg-flag conditions as contraindications to OTC hearing aid use :
- Visible congenital or traumatic deformity of the ear preventing insertion of the receiver wire and dome into the ear.
- History of sudden active drainage (i.e. blood or pus) from the ear within the previous 6 months.
Show all 11Show fewer
- Painful or uncomfortable feeling in your ear (iv) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
- History of sudden or rapidly progressive hearing loss within the previous 6 months.
- Acute or chronic dizziness. (vii) Unilateral hearing loss. (viii) Fluctuating hearing loss (ix) Unilateral tinnitus
- Low English proficiency - <51% of EF-SET
- No access or in possession of a smartphone, compatible with the Lexie App (minimum iOS 13 or Android OS 10)
About this study
Official title: Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid in Adults With Perceived Mild-Moderate Hearing Loss: A Three Phased Approach
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption, even in high-income countries with developed audiological services . Traditionally, hearing aids required professional consultations, restricting access. However, in 2022, the U.S. FDA approved over-the-counter (OTC) hearing aids, including self-fitting devices, to improve accessibility. Recent clinical trials suggest that OTC hearing aids can deliver similar benefits to professionally fitted ones in speech recognition and self-reported outcomes.
Critiques of these studies have focused on using the same device model for both groups rather than comparing it to established prescription hearing aids. To address this, the current study employs a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer, Phase 2 assesses user experience, and Phase 3 involves a randomized control trial comparing a self-fitting OTC hearing aid with a professionally fitted prescription device. The hypothesis is that both devices offer equivalent benefits.
This research is novel as no previous studies have directly compared self-fitting OTC and commercially available prescription hearing aids. This study will compare the effectiveness of an OTC self-fitting hearing aid against a prescription device using a crossover randomized control trial.
Read the detailed description
Hearing loss is a prevalent condition affecting a significant portion of the global population, leading to challenges in communication, social interactions, and overall quality of life. Recent data indicates that over 1.5 billion individuals worldwide experience some degree of hearing loss, with 430 million facing disabling hearing impairments. For adults with sensorineural hearing loss, hearing aids are the primary intervention to enhance auditory function. Conventionally, obtaining hearing aids involves comprehensive diagnostic assessments, device selection, and personalized fitting conducted by hearing care professionals. While this method ensures tailored care, it can also pose accessibility challenges, including financial constraints, limited availability of trained professionals, and social stigma associated with hearing aid use. These barriers contribute to the limited adoption and underutilization of hearing aids, even in regions with adequate audiological services.
To address these accessibility issues, over-the-counter (OTC) hearing aids have been introduced as a viable alternative. This model empowers individuals with perceived mild to moderate hearing loss to independently select and fit hearing aids without the necessity of professional evaluations. The U.S. Food and Drug Administration (FDA) established regulations for OTC hearing aids, which took effect on October 17, 2022. These regulations aim to increase accessibility and affordability of hearing care solutions. The introduction of OTC hearing aids represents a shift towards consumer hearing care. By allowing individuals to manage their hearing needs independently, OTC hearing aids have the potential to reduce barriers associated with traditional hearing aid procurement, such as high costs and limited access to audiologists. This newer model of care aligns with a broader public health goal to enhance the availability of hearing aids.
Recent clinical trials have indicated that over-the-counter (OTC) hearing aids can provide benefits comparable to those of professionally fitted devices, particularly in the areas of user-reported satisfaction. For instance, a randomized clinical trial compared the effectiveness of a self-fitting OTC hearing aid with remote support to that of an audiologist-fitted device. The study found that self-reported outcomes and speech recognition in noise benefits were noninferior in the self-fitting group compared to the audiologist-fitted group. Despite these promising findings, critiques have emerged regarding the methodologies of this and other similar studies. A primary concern is that many studies utilize the same device model for both the OTC and professionally fitted groups, rather than comparing OTC devices to established prescription hearing aids. This approach may limit the generalizability of the results, as it does not account for the variability in performance across different hearing aid models. Therefore, there is a need for studies that compare self-fitting OTC hearing aids directly with prescription devices to provide a more comprehensive understanding of their relative effectiveness. The aim of this randomized controlled trial is to compare the effectiveness of a self-fitting OTC hearing aid to a prescription hearing aid. This trial forms a part of a larger validation study, that includes two other phases (validating an in-situ hearing test and usability assessment of the self-fitting OTC hearing aid). However, we describe here only the effectiveness trial (Phase 3). The hypothesis is that the self-fitting OTC hearing aid will provide non-inferior benefits compared to the professionally fitted prescription hearing aid in terms of user-reported outcomes and speech recognition in noise. Several other exploratory measures will also be evaluated through the course of the trial.
- Conditions
- Hearing Loss, Hearing Impairment
- Being tested
- OTC self-fitting hearing aid, Prescription hearing aid
- Keywords
- hearing loss, over-the-counter hearing aid, self-fitting hearing aid, prescription hearing aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTC self-fitting hearing aidDevice
Also called OTC hearing aid
OTC hearing aid to be compared to prescription hearing aid
Prescription hearing aidDevice
Prescription hearing aid used as active comparator to the OTC self-fitting hearing aid
| Study group | Role | What they receive |
|---|---|---|
| OTC SF Group | Experimental | Participants in this group will field trial a self-fitting over-the-counter (OTC SF) hearing aid. Each participant will independently set up and adjust their device without any professional assistance, following standard self-fitting procedures. They will receive only the manufacturer-provided instructional materials, including the user manual and quick start guide, as would be typical for real-world OTC hearing aid use. This process reflects the intended consumer-directed experience for OTC hearing aids. Receives: Device: OTC self-fitting hearing aid |
| Prescription Group | Active comparator | Participants in this group will use a professionally fitted prescription hearing aid. A licensed audiologist will conduct a comprehensive hearing evaluation, followed by device selection (receiver wires and domes), programming, and individualized fitting based on best practice protocols. The fitting will be fine-tuned using real-ear measurements (REM) to ensure optimal amplification settings tailored to each participant's hearing profile. Additionally, participants will receive professional counseling on device use, care, and expectations, reflecting the standard clinical hearing aid fitting process. Receives: Device: Prescription hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB will be the primary effectiveness endpoint measure for the trial. It is a standardised questionnaire used to assess the effectiveness of hearing aids. It measures the user's perceived hearing difficulties in various everyday situations both with and without their hearing aids, across four subscales: ease of communication, reverberation, background noise, and aversiveness of sounds. The results help to quantify the benefits and limitations of hearing aid use from the user's perspective. The APHAB global score is calculated by averaging the scores across three specific subscales of the APHAB: Ease of Communication, Reverberation, and Background Noise and will serve as the primary effectiveness outcome variable for the study phase. Patients report the percentage of time they experience difficulty in each situation (1% - 99%), with and without hearing aids. Benefit is calculated by comparing the unaided and aided scores, with higher benefit scores indicating better outcomes.
Measured: Baseline, three weeks and six weeks
Secondary outcomes (3)
International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA is a standardised questionnaire designed to evaluate the overall effectiveness and user satisfaction with hearing aids. It consists of seven items that assess key aspects such as daily use, benefit, residual activity limitations, satisfaction, residual participation restrictions, impact on others, and quality of life. The scale is ordinal in nature, but a total score can be calculated as the sum of all seven items. Each item is rated on a 5-point scale, with higher scores indicating more favorable outcomes. The total score ranges from 7 to 35, with higher scores reflecting greater benefit and satisfaction from hearing aid use.
Measured: Three weeks and six weeks
Quick Speech in Noise Test (QuickSIN)
The QuickSIN is a clinically used assessment tool designed to evaluate an individual's ability to understand speech in noisy environments by presenting speech in multi-talker babble noise. During the test, six sentences-each containing five key words-are presented with four-talker babble noise. The speech level decreases in 5 dB steps from a signal-to-noise ratio (SNR) of 25 dB to 0 dB. Patients repeat each sentence, and clinicians score one point for each correctly repeated key word, totaling up to 30 points per list. The SNR loss is calculated by subtracting the total correct words from 25.5. Lower SNR loss values indicate better speech understanding in noisy environments. Three lists will be completed at each assessment point, and the average SNR of the three lists will be used for the final calculation.
Measured: Baseline, three weeks and six weeks
Real ear aided response (REAR)
REAR is a measure used to evaluate the sound level at the eardrum when a hearing aid is worn and active. It captures how the hearing aid amplifies sound across different frequencies directly in the user's ear canal.
In relation to NAL-NL2 targets, REAR is used to verify that the hearing aid's amplification matches the prescribed targets set by the NAL-NL2 fitting formula. NAL-NL2 is a widely used prescriptive method for fitting hearing aids, aiming to optimise speech intelligibility while maintaining comfort. During a fitting, the audiologist measures the REAR and compares it to the NAL-NL2 targets to ensure that the hearing aid is providing the appropriate gain for the user's specific hearing loss, ensuring optimal hearing aid performance and user satisfaction. We will determine how far the REAR is from NAL-NL2 prescriptive target in decibel sound pressure level [dB SPL] at 0.5, 1,2 and 4 kHz. A lower number in dB SPL (NAL-NL2 target - REAR) suggests closer alignment to target.
Measured: Three weeks and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The study was withdrawn before enrollment for administrative reasons.
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HearX SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karina C De Sousa, PhD, Principal investigator, hearX Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942325
- Sponsor's protocol ID
- Lexie
- Acronym
- Lexie
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is conducted under the South African Health Products Regulatory Authority (SAHPRA) and US Food and Drug Administration (FDA) Institutional regulations, which impose strict guidelines on the handling and sharing of medical device trial data. Furthermore, the data may contain proprietary or commercially sensitive information related to the device's performance. Sharing IPD could compromise intellectual property or competitive interests of the device manufacturer. While the raw IPD will not be shared, aggregate-level data, summary statistics, and study findings may be published and made available in peer-reviewed journals and reports.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Effectiveness of a Self-fitting Over-the-counter Hearing Aid in Adults With Perceived Mild-Moderate Hearing Loss: A Three Phased Approach
- ClinicalTrials.gov ID
- NCT06942325
- Acronym / sponsor ID
- Lexie / Lexie
- Conditions
- Hearing Loss, Hearing Impairment
- Keywords
- hearing loss, over-the-counter hearing aid, self-fitting hearing aid, prescription hearing aid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn before enrollment for administrative reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HearX SAIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 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.
Hearing loss significantly affects quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a proven intervention, yet barriers like access and affordability limit their adoption, even in high-income countries with developed audiological services . Traditionally, hearing aids required professional consultations, restricting access. However, in 2022, the U.S. FDA approved over-the-counter (OTC) hearing aids, including self-fitting devices, to improve accessibility. Recent clinical trials suggest that OTC hearing aids can deliver similar benefits to professionally fitted ones in speech recognition and self-reported outcomes.
Critiques of these studies have focused on using the same device model for both groups rather than comparing it to established prescription hearing aids. To address this, the current study employs a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer, Phase 2 assesses user experience, and Phase 3 involves a randomized control trial comparing a self-fitting OTC hearing aid with a professionally fitted prescription device. The hypothesis is that both devices offer equivalent benefits.
This research is novel as no previous studies have directly compared self-fitting OTC and commercially available prescription hearing aids. This study will compare the effectiveness of an OTC self-fitting hearing aid against a prescription device using a crossover randomized control trial.
Detailed description
Hearing loss is a prevalent condition affecting a significant portion of the global population, leading to challenges in communication, social interactions, and overall quality of life. Recent data indicates that over 1.5 billion individuals worldwide experience some degree of hearing loss, with 430 million facing disabling hearing impairments. For adults with sensorineural hearing loss, hearing aids are the primary intervention to enhance auditory function. Conventionally, obtaining hearing aids involves comprehensive diagnostic assessments, device selection, and personalized fitting conducted by hearing care professionals. While this method ensures tailored care, it can also pose accessibility challenges, including financial constraints, limited availability of trained professionals, and social stigma associated with hearing aid use. These barriers contribute to the limited adoption and underutilization of hearing aids, even in regions with adequate audiological services.
To address these accessibility issues, over-the-counter (OTC) hearing aids have been introduced as a viable alternative. This model empowers individuals with perceived mild to moderate hearing loss to independently select and fit hearing aids without the necessity of professional evaluations. The U.S. Food and Drug Administration (FDA) established regulations for OTC hearing aids, which took effect on October 17, 2022. These regulations aim to increase accessibility and affordability of hearing care solutions. The introduction of OTC hearing aids represents a shift towards consumer hearing care. By allowing individuals to manage their hearing needs independently, OTC hearing aids have the potential to reduce barriers associated with traditional hearing aid procurement, such as high costs and limited access to audiologists. This newer model of care aligns with a broader public health goal to enhance the availability of hearing aids.
Recent clinical trials have indicated that over-the-counter (OTC) hearing aids can provide benefits comparable to those of professionally fitted devices, particularly in the areas of user-reported satisfaction. For instance, a randomized clinical trial compared the effectiveness of a self-fitting OTC hearing aid with remote support to that of an audiologist-fitted device. The study found that self-reported outcomes and speech recognition in noise benefits were noninferior in the self-fitting group compared to the audiologist-fitted group. Despite these promising findings, critiques have emerged regarding the methodologies of this and other similar studies. A primary concern is that many studies utilize the same device model for both the OTC and professionally fitted groups, rather than comparing OTC devices to established prescription hearing aids. This approach may limit the generalizability of the results, as it does not account for the variability in performance across different hearing aid models. Therefore, there is a need for studies that compare self-fitting OTC hearing aids directly with prescription devices to provide a more comprehensive understanding of their relative effectiveness. The aim of this randomized controlled trial is to compare the effectiveness of a self-fitting OTC hearing aid to a prescription hearing aid. This trial forms a part of a larger validation study, that includes two other phases (validating an in-situ hearing test and usability assessment of the self-fitting OTC hearing aid). However, we describe here only the effectiveness trial (Phase 3). The hypothesis is that the self-fitting OTC hearing aid will provide non-inferior benefits compared to the professionally fitted prescription hearing aid in terms of user-reported outcomes and speech recognition in noise. Several other exploratory measures will also be evaluated through the course of the trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTC SF Group | Experimental | Device: OTC self-fitting hearing aidParticipants in this group will field trial a self-fitting over-the-counter (OTC SF) hearing aid. Each participant will independently set up and adjust their device without any professional assistance, following standard self-fitting procedures. They will receive only the manufacturer-provided instructional materials, including the user manual and quick start guide, as would be typical for real-world OTC hearing aid use. This process reflects the intended consumer-directed experience for OTC hearing aids. |
| Prescription Group | Active comparator | Device: Prescription hearing aidParticipants in this group will use a professionally fitted prescription hearing aid. A licensed audiologist will conduct a comprehensive hearing evaluation, followed by device selection (receiver wires and domes), programming, and individualized fitting based on best practice protocols. The fitting will be fine-tuned using real-ear measurements (REM) to ensure optimal amplification settings tailored to each participant's hearing profile. Additionally, participants will receive professional counseling on device use, care, and expectations, reflecting the standard clinical hearing aid fitting process. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be 18 years or older.
- The outer ear must be free from excessive cerumen, outer or middle ear disease (determined through otoscopic examination of the ear)
- The participant must have bilateral self-perceived mild-moderate hearing loss.
- Baseline pure tone evaluations should fall within a 4-frequency PTA (0.5, 1.0, 2.0, 4.0 kHz) of 65 dB HL or less.
- The participant must have an adequate level of English proficiency as measured objectively using an English proficiency test (EF SET).
Key exclusion criteria (11 listed)
- Younger than 18 years
- Presents with severe or greater hearing loss in either ear
- Presents with an outer or middle ear abnormality
- Have any of the following as per FDA (21 CFR 801.420) reg-flag conditions as contraindications to OTC hearing aid use :
- Visible congenital or traumatic deformity of the ear preventing insertion of the receiver wire and dome into the ear.
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 |
|---|---|---|
| OTC self-fitting hearing aidAlso: OTC hearing aidOTC hearing aid to be compared to prescription hearing aid | Device | OTC SF Group |
| Prescription hearing aidPrescription hearing aid used as active comparator to the OTC self-fitting hearing aid | Device | Prescription Group |
Primary outcome
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Baseline, three weeks and six weeks
The APHAB will be the primary effectiveness endpoint measure for the trial. It is a standardised questionnaire used to assess the effectiveness of hearing aids. It measures the user's perceived hearing difficulties in various everyday situations both with and without their hearing aids, across four subscales: ease of communication, reverberation, background noise, and aversiveness of sounds. The results help to quantify the benefits and limitations of hearing aid use from the user's perspective. The APHAB global score is calculated by averaging the scores across three specific subscales of the APHAB: Ease of Communication, Reverberation, and Background Noise and will serve as the primary effectiveness outcome variable for the study phase. Patients report the percentage of time they experience difficulty in each situation (1% - 99%), with and without hearing aids. Benefit is calculated by comparing the unaided and aided scores, with higher benefit scores indicating better outcomes.
3 secondary outcomes
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: Three weeks and six weeks
Quick Speech in Noise Test (QuickSIN)
Time frame: Baseline, three weeks and six weeks
Real ear aided response (REAR)
Time frame: Three weeks and six weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. The study is conducted under the South African Health Products Regulatory Authority (SAHPRA) and US Food and Drug Administration (FDA) Institutional regulations, which impose strict guidelines on the handling and sharing of medical device trial data. Furthermore, the data may contain proprietary or commercially sensitive information related to the device's performance. Sharing IPD could compromise intellectual property or competitive interests of the device manufacturer. While the raw IPD will not be shared, aggregate-level data, summary statistics, and study findings may be published and made available in peer-reviewed journals and reports.
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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.
Karina C De Sousa, PhD principal investigator
hearX Group
Questions about this trial
What is this clinical trial studying?
A study testing OTC self-fitting hearing aid and Prescription hearing aid in people with Hearing Loss and Hearing Impairment, run by HearX SA.
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 11 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: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: Baseline, three weeks and six weeks). 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 20 Nov 2025.