Clinical Validation of the Lexie Lumen Hearing Aid

NCT ID: NCT05337748

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2022-10-01

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.

Detailed Description

Objective: To examine the difference in outcomes (satisfaction and objective benefit) of the Lexie self-test and self-fitting (Lexie- STF) hearing aid versus a Lexie hearing aid fitted professionally with a clinically obtained audiogram (Lexie-PTF) (n = 60).

Hypothesis: It is hypothesized that the Lexie-STF (experimental group) will be non-inferior to the Lexie-PFT (control group) in terms of perceived satisfaction, speech perception in noise and real-ear measurements.

Design: A randomized control trial (RCT) will be conducted cross-sectionally (45 days) to evaluate the efficacy of Lexie-STF compared to Lexie-PTF.

Setting: This study will involve clinical, audiometric testing as well as a user field-trial of the fitted hearing aids.

Participants: Eligible participants will include 60 adults (18 to 99 years) with a self-perceived level of hearing loss, free from symptoms of ear disease or excessive cerumen and who own a smartphone (Android or iOS). Participants will be recruited for each group and will randomly be assigned using a computer-generated randomization by an independent research assistant, after being stratified for sex and degree of hearing loss.

Intervention: The experimental group (Lexie-STF) will be provided with Lexie Lumen hearing aids and accompanying smartphone application, that will be automatically fitted according to the participants in-situ audiogram. Participants will then be able to self-adjust their hearing aid settings (prescriptive gain) after a period of two weeks. The control group (Lexie PTF) will be professionally fitted by a certified audiologist with the Lexie Lumen hearing aids, according to gold-standard NAL-NL2 prescriptive gain targets using a standard clinically obtained audiogram.

Outcome measures: The main outcome measure is the Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary outcome measures will be the International Outcome Inventory for Hearing Aids (IOI-HA), the QuickSIN speech-in-noise test and real-ear-measurements (REMs).

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental : Lexie Self Test and Fit Group (Lexie STF)

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.

Group Type: EXPERIMENTAL

Lexie Self Test and Fit Group

Intervention Type: DEVICE

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.

Control: Lexie Professional Test and Fit Group (Lexie PTF)

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.

Group Type: ACTIVE_COMPARATOR

Lexie Professional Test and Fit Group

Intervention Type: DEVICE

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.

Interventions

Lexie Self Test and Fit Group

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.

Intervention Type: DEVICE

Lexie Professional Test and Fit Group

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.

Intervention Type: DEVICE

Other Intervention Names

Lexie STF); Lexie PFT

Eligibility Criteria

Inclusion Criteria

1. Adults aged between the ages of 18 to 99 years, living in South Africa.

2. Good English proficiency (measured using an online English proficiency test as well as self-report of English speaking competence)

3. Must have a self-perceived hearing loss

4. Mild to severe sensorineural hearing loss (thresholds <= 80 dB HL across frequencies bilaterally)

5. Possession of a smartphone compatible with the Lexie app (iOS or Android)

6. Access to mobile data to operate the Lexie app.

7. Willingness and availability to participate in the study over a period of 45 days

Exclusion Criteria

1. Normal hearing or profound hearing loss

2. Active outer or middle ear disease

3. Poor English proficiency

4. Diagnosed cognitive impairment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

hearX Group

INDUSTRY

Sponsor Role: lead

University of Pretoria

OTHER

Sponsor Role: collaborator

Responsible Party

De Wet Swanepoel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

De Wet Swanepoel, PhD

Role: PRINCIPAL_INVESTIGATOR

hearX Group

Locations

University of Pretoria

Pretoria, Gauteng, South Africa

Countries

South Africa

References

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.

Reference Type: BACKGROUND

PMID: 33953438 (View on PubMed)

Keidser G, Convery E. Self-Fitting Hearing Aids: Status Quo and Future Predictions. Trends Hear. 2016 Apr 12;20:2331216516643284. doi: 10.1177/2331216516643284.

Reference Type: BACKGROUND

PMID: 27072929 (View on PubMed)

De 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.

Reference Type: DERIVED

PMID: 37052929 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LexieLumen

Identifier Type: -

Identifier Source: org_study_id