Clinical Validation of the Lexie Lumen Hearing Aid
1 other identifier
interventional
68
1 country
1
Brief Summary
More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation. The majority of people with hearing loss have mild to moderate degrees, for which the most effective treatment options are hearing aids. Over the past few years, there have been many developments in hearing technology and the service delivery models in which they are supplied. Traditional hearing care models include several visits to a qualified hearing professional who must both perform diagnostics and prescribe hearing aids, which in the past has been the only way to obtain hearing aids. However, newer developments include forms of self-fitting hearing aids that enable a user to perform threshold measurements to determine the degree of hearing loss and automatically program and fine-tune hearing aids. These devices are now becoming available as direct-to-consumer (DTC) or over-the-counter (OTC) hearing aids. Furthermore, alternative care models have been suggested to bolster access and uptake of assistive technology for hearing loss. Regulations on DTC and OTC hearing aids are starting to come into effect. In 2017, the FDA Reauthorization Act of 2016 directed the FDA to create a category for OTC hearing aids for adults with perceived mild-to-moderate hearing loss. In October 2021, the FDA formally proposed a rule to establish the OTC hearing aid category as part of this process. These changes in regulations would mean that soon, many of these self-fitting devices will become available. In response to these changes in service delivery models, the hearX group recently developed the Lexie Lumen hearing aids that can perform in-situ hearing threshold estimations and automatically prescribe hearing aid gain settings that closely approximate the gold-standard NAL-NL2 fitting prescription. This study aims to evaluate whether the performance of the novel Lexie self-test and self-fitting hearing aid is equivalent to the same hearing aid programmed professionally by an audiologist using a professionally obtained audiogram.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2022
CompletedStudy Start
First participant enrolled
April 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedResults Posted
Study results publicly available
March 20, 2025
CompletedMarch 20, 2025
March 1, 2025
6 months
April 7, 2022
February 28, 2024
March 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abbreviated Profile of Hearing Aid Benefit (APHAB)
The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24 item self-assessment inventory in which patients report the amount of trouble they experience hearing and communicating in noise in different everyday listening environments. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).The final score is determined by subtracting the aided average from the unaided average, keeping in mind that the score indicates how frequently the individual experiences communication difficulty. Therefore a higher score indicates a poorer outcome. (Minimum score 1% to a maximum score of 99%).
Change from baseline assessment to final assessment after 30 day field trial use.
Secondary Outcomes (4)
International Outcome Inventory for Hearing Aids (IOI-HA)
Final assessment after 30 day field use
QuickSIN Speech in Noise Test
Baseline and benefit at the end of 30 day field use
Digits-in-noise Test (DIN)
Baseline unaided test and aided fitting final assessment after 30 day field use
Live Speech Mapping Using Real Ear Measurements (REM)
Final assessment after 30 day field use
Study Arms (2)
Experimental : Lexie Self Test and Fit Group (Lexie STF)
EXPERIMENTALThe intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.
Control: Lexie Professional Test and Fit Group (Lexie PTF)
ACTIVE COMPARATORThe intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Interventions
The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.
The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Eligibility Criteria
You may qualify if:
- Adults aged between the ages of 18 to 99 years, living in South Africa.
- Good English proficiency (measured using an online English proficiency test as well as self-report of English speaking competence)
- Must have a self-perceived hearing loss
- Mild to severe sensorineural hearing loss (thresholds \<= 80 dB HL across frequencies bilaterally)
- Possession of a smartphone compatible with the Lexie app (iOS or Android)
- Access to mobile data to operate the Lexie app.
- Willingness and availability to participate in the study over a period of 45 days
You may not qualify if:
- Normal hearing or profound hearing loss
- Active outer or middle ear disease
- Poor English proficiency
- Diagnosed cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- hearX Grouplead
- University of Pretoriacollaborator
Study Sites (1)
University of Pretoria
Pretoria, Gauteng, 0001, South Africa
Related Publications (3)
Chadha S, Kamenov K, Cieza A. The world report on hearing, 2021. Bull World Health Organ. 2021 Apr 1;99(4):242-242A. doi: 10.2471/BLT.21.285643. No abstract available.
PMID: 33953438BACKGROUNDKeidser G, Convery E. Self-Fitting Hearing Aids: Status Quo and Future Predictions. Trends Hear. 2016 Apr 12;20:2331216516643284. doi: 10.1177/2331216516643284.
PMID: 27072929BACKGROUNDDe Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376.
PMID: 37052929DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor De Wet Swanepoel
- Organization
- University of Pretoria
Study Officials
- PRINCIPAL INVESTIGATOR
De Wet Swanepoel, PhD
hearX Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 20, 2022
Study Start
April 11, 2022
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
March 20, 2025
Results First Posted
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share