Hearing LossNCT06878300
Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid
A study testing Over the counter hearing aid (Lexie) and Comparator over the counter hearing aid in people with Hearing Loss and Self Perceived Hearing Loss, run by HearX SA.
Trial summary
Hearing loss significantly impacts quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a well-established intervention, yet barriers such as access and affordability limit their adoption, even in countries with developed audiological services . Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Self Perceived Hearing Loss, Hearing Impairment
- What is being tested?
- Over the counter hearing aid (Lexie) and Comparator over the counter 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 Jul 2025to 31 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 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant must be 18 years or older.
- The outer ear must be free from excessive cerumen, outer or middle ear disease.
- 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 present with Type A or As or Ad tympanogram as measured by tympanometry.
- Must be in possession of a smartphone compatible with the Lexie App (Android OS 8)
Who cannot join
- Younger than 18 years
- Severe or greater hearing loss
- 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.
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- 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 an Android smartphone, compatible with the Lexie App (minimum Android OS 8)
About this study
Official title: Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid in Adults With Perceived Mild-Moderate Hearing Loss: A Three Phased Approach
Hearing loss significantly impacts quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a well-established intervention, yet barriers such as access and affordability limit their adoption, even in countries with developed audiological services . Despite their proven benefits, many individuals who could benefit from hearing aids do not obtain them. Traditionally, hearing aids required professional consultations, which created access challenges. 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 provide similar benefits to professionally fitted ones in speech recognition and self-reported outcomes.
One critique of past studies is that they often compare OTC hearing aids to audiologist-fitted devices using the same hardware, with differences primarily in programming methods. While much research has focused on fitting methods, this study aims to evaluate a new OTC hearing aid with its proprietary fitting algorithm against a marketed competitor. This randomized controlled trial (RCT) forms part of a larger validation study that follows a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer and Phase 2 assesses user experience. This RCT (Phase 3) will compare two OTC devices-the Lexie B3 Pro and a competitor already on the market-to evaluate self-reported benefit, user experience, and satisfaction. The hypothesis is that both devices provide comparable outcomes.
Read the detailed description
Hearing loss is a prevalent global health concern with significant social, emotional, and economic consequences. Sensorineural hearing loss (SNHL) is the most common type among adults, often resulting from aging, noise exposure, or ototoxic medication. Left untreated, hearing loss can lead to communication difficulties, social isolation, depression, cognitive decline, and reduced quality of life. Hearing aids are the most widely used intervention for addressing hearing impairment, offering substantial benefits in speech perception, communication, and overall well-being. However, despite the well-documented advantages of hearing aids, adoption rates remain low across various populations.
Barriers to hearing aid adoption include cost, accessibility, stigma, and the traditional requirement for professional fitting. In many countries, hearing aids are expensive, and access to hearing healthcare professionals is limited, particularly in rural or underserved areas. Even in regions with well-established audiological services, individuals may face challenges such as lengthy appointment wait times, insurance limitations, or the perception that hearing aids are not necessary until hearing loss is severe.
To address accessibility challenges, the U.S. Food and Drug Administration (FDA) introduced regulations in 2022 allowing the sale of over-the-counter (OTC) hearing aids. These devices are designed for adults with perceived mild-to-moderate hearing loss and can be purchased without the need for a professional hearing assessment or fitting. OTC hearing aids aim to lower barriers by providing a more affordable, convenient, and consumer-driven option. Among OTC hearing aids, self-fitting models offer additional benefits, as users can fine-tune their settings using built-in hearing tests or app-based adjustments, potentially achieving outcomes comparable to those of audiologist-fitted hearing aids.
Emerging research suggests that OTC hearing aids can be effective in improving speech recognition and self-reported hearing outcomes, with some studies indicating that self-fitting devices perform similarly to traditional, professionally fitted hearing aids. However, there is ongoing debate regarding the best methods for fitting and personalizing these devices. Previous research has often compared OTC hearing aid fitting methods to audiologist fittings using the same hardware, with the primary difference being the programming approach rather than the device itself. This approach has drawn criticism because it does not fully reflect real-world consumer decisions, where individuals must choose between different OTC models with varying features, fitting algorithms, and user interfaces.
This study aims to address this gap by directly comparing two distinct OTC hearing aids: the Lexie B3 Pro, which features a proprietary self-fitting algorithm, and a competing marketed device. The goal is to assess whether both devices offer comparable outcomes in terms of self-reported benefit, user experience, and satisfaction.
- Being tested
- Over the counter hearing aid (Lexie), Comparator over the counter hearing aid
- Keywords
- over the counter hearing aids, self-fitting hearing aids, hearing aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over the counter hearing aid (Lexie)Device
The study will compare user perceptions of two over-the-counter (OTC) hearing aids, with the Lexie B3 Pro serving as the reference device. Participants will be fitted with each device for a predetermined period in a randomized order to ensure balanced exposure.
Comparator over the counter hearing aidDevice
The comparator OTC hearing aid will undergo the same evaluation process as the Lexie B3 Pro, ensuring an equivalent and unbiased comparison. Participants will be provided with the comparator device along with its standard user instructions, including any mobile applications or self-fitting guidance designed for independent setup.
| Study group | Role | What they receive |
|---|---|---|
| OTC SF (Lexie) | Experimental | Participants in this group will be provided with a Lexie self-fitting OTC hearing aid that features a proprietary fitting algorithm designed to optimize amplification settings based on user input. Participants will independently set up and adjust the device without professional assistance, following the manufacturer's instructions, as would be the standard use case for self-fitting hearing aids. They will use the device for a two-week take-home field trial before crossing over to the alternative study arm. Receives: Device: Over the counter hearing aid (Lexie) |
| OTC SF Competitor | Experimental | Participants in this group will receive a different self-fitting OTC hearing aid that utilizes its own manufacturer-specific fitting approach. As in the experimental arm, participants will complete the setup independently without professional guidance, adjusting the device based on the available self-fitting process. They will use this device for a two-week take-home field trial before switching to the experimental arm. Receives: Device: Comparator over the counter hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing aid perception questionnaire
To achieve the study's primary objective of comparing the self-fitting Lexie B3 Pro OTC hearing aid device with the comparable market-available OTC self-fitting device, the primary outcome will be measured using a self-developed questionnaire with Likert scale questions. This questionnaire is designed to gather detailed insights into participants' perceptions of the devices' features and their experiences using both the self-fitting Lexie B3 Pro device and the market-available model after completing each field trial. No specific scoring is used as the study aims to obtain descriptive insights between the two devices.
Measured: At the end of the two week field trial (with each device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Jul 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
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
- Treatment
- 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
- NCT06878300
- Sponsor's protocol ID
- LexieB3Pro
- 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
- Assessing Functional Outcomes and User Experience of the Lexie B3 Pro Powered by Bose Over-the-counter Self-Fitting Hearing Aid in Adults With Perceived Mild-Moderate Hearing Loss: A Three Phased Approach
- ClinicalTrials.gov ID
- NCT06878300
- Acronym / sponsor ID
- LexieB3Pro
- Keywords
- over the counter hearing aids, self-fitting hearing aids, hearing aids
- 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 Jul 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 14 Mar 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 impacts quality of life, with sensorineural hearing loss being the most common type among adults. Hearing aids are a well-established intervention, yet barriers such as access and affordability limit their adoption, even in countries with developed audiological services . Despite their proven benefits, many individuals who could benefit from hearing aids do not obtain them. Traditionally, hearing aids required professional consultations, which created access challenges. 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 provide similar benefits to professionally fitted ones in speech recognition and self-reported outcomes.
One critique of past studies is that they often compare OTC hearing aids to audiologist-fitted devices using the same hardware, with differences primarily in programming methods. While much research has focused on fitting methods, this study aims to evaluate a new OTC hearing aid with its proprietary fitting algorithm against a marketed competitor. This randomized controlled trial (RCT) forms part of a larger validation study that follows a phased approach. Phase 1 validates an in-situ hearing test against a standard audiometer and Phase 2 assesses user experience. This RCT (Phase 3) will compare two OTC devices-the Lexie B3 Pro and a competitor already on the market-to evaluate self-reported benefit, user experience, and satisfaction. The hypothesis is that both devices provide comparable outcomes.
Detailed description
Hearing loss is a prevalent global health concern with significant social, emotional, and economic consequences. Sensorineural hearing loss (SNHL) is the most common type among adults, often resulting from aging, noise exposure, or ototoxic medication. Left untreated, hearing loss can lead to communication difficulties, social isolation, depression, cognitive decline, and reduced quality of life. Hearing aids are the most widely used intervention for addressing hearing impairment, offering substantial benefits in speech perception, communication, and overall well-being. However, despite the well-documented advantages of hearing aids, adoption rates remain low across various populations.
Barriers to hearing aid adoption include cost, accessibility, stigma, and the traditional requirement for professional fitting. In many countries, hearing aids are expensive, and access to hearing healthcare professionals is limited, particularly in rural or underserved areas. Even in regions with well-established audiological services, individuals may face challenges such as lengthy appointment wait times, insurance limitations, or the perception that hearing aids are not necessary until hearing loss is severe.
To address accessibility challenges, the U.S. Food and Drug Administration (FDA) introduced regulations in 2022 allowing the sale of over-the-counter (OTC) hearing aids. These devices are designed for adults with perceived mild-to-moderate hearing loss and can be purchased without the need for a professional hearing assessment or fitting. OTC hearing aids aim to lower barriers by providing a more affordable, convenient, and consumer-driven option. Among OTC hearing aids, self-fitting models offer additional benefits, as users can fine-tune their settings using built-in hearing tests or app-based adjustments, potentially achieving outcomes comparable to those of audiologist-fitted hearing aids.
Emerging research suggests that OTC hearing aids can be effective in improving speech recognition and self-reported hearing outcomes, with some studies indicating that self-fitting devices perform similarly to traditional, professionally fitted hearing aids. However, there is ongoing debate regarding the best methods for fitting and personalizing these devices. Previous research has often compared OTC hearing aid fitting methods to audiologist fittings using the same hardware, with the primary difference being the programming approach rather than the device itself. This approach has drawn criticism because it does not fully reflect real-world consumer decisions, where individuals must choose between different OTC models with varying features, fitting algorithms, and user interfaces.
This study aims to address this gap by directly comparing two distinct OTC hearing aids: the Lexie B3 Pro, which features a proprietary self-fitting algorithm, and a competing marketed device. The goal is to assess whether both devices offer comparable outcomes in terms of self-reported benefit, user experience, and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTC SF (Lexie) | Experimental | Device: Over the counter hearing aid (Lexie)Participants in this group will be provided with a Lexie self-fitting OTC hearing aid that features a proprietary fitting algorithm designed to optimize amplification settings based on user input. Participants will independently set up and adjust the device without professional assistance, following the manufacturer's instructions, as would be the standard use case for self-fitting hearing aids. They will use the device for a two-week take-home field trial before crossing over to the alternative study arm. |
| OTC SF Competitor | Experimental | Device: Comparator over the counter hearing aidParticipants in this group will receive a different self-fitting OTC hearing aid that utilizes its own manufacturer-specific fitting approach. As in the experimental arm, participants will complete the setup independently without professional guidance, adjusting the device based on the available self-fitting process. They will use this device for a two-week take-home field trial before switching to the experimental arm. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant must be 18 years or older.
- The outer ear must be free from excessive cerumen, outer or middle ear disease.
- 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
- Severe or greater hearing loss
- 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 :
- History of sudden active drainage (i.e. blood or pus) from the ear within the previous 6 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 |
|---|---|---|
| Over the counter hearing aid (Lexie)The study will compare user perceptions of two over-the-counter (OTC) hearing aids, with the Lexie B3 Pro serving as the reference device. Participants will be fitted with each device for a predetermined period in a randomized order to ensure balanced exposure. | Device | OTC SF (Lexie) |
| Comparator over the counter hearing aidThe comparator OTC hearing aid will undergo the same evaluation process as the Lexie B3 Pro, ensuring an equivalent and unbiased comparison. Participants will be provided with the comparator device along with its standard user instructions, including any mobile applications or self-fitting guidance designed for independent setup. | Device | OTC SF Competitor |
Primary outcome
Hearing aid perception questionnaire
Time frame: At the end of the two week field trial (with each device)
To achieve the study's primary objective of comparing the self-fitting Lexie B3 Pro OTC hearing aid device with the comparable market-available OTC self-fitting device, the primary outcome will be measured using a self-developed questionnaire with Likert scale questions. This questionnaire is designed to gather detailed insights into participants' perceptions of the devices' features and their experiences using both the self-fitting Lexie B3 Pro device and the market-available model after completing each field trial. No specific scoring is used as the study aims to obtain descriptive insights between the two devices.
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 Over the counter hearing aid (Lexie) and Comparator over the counter hearing aid in people with Hearing Loss and Self Perceived Hearing Loss, 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?
Hearing aid perception questionnaire (time frame: At the end of the two week field trial (with each device)). 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.