Clinical trial NCT05337748: Clinical Validation of the Lexie Lumen Hearing Aid
Official title: Clinical Validation of the Lexie Lumen Over the Counter Hearing Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss
hearing aid
hearing rehabilitation
self-fitting hearing aid
Lead sponsor: hearX Group
Sponsor class: INDUSTRY
Collaborators: name: University of Pretoria
First posted: 2022-04-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will undergo the self-test and fitting (Lexie STF) intervention and the experimental group will undergo the professional test and fit (Lexie PTF) intervention.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Change from baseline assessment to final assessment after 30 day field trial use.
Secondary outcomes:
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: Final assessment after 30 day field use
measure: QuickSIN Speech in Noise Test
timeFrame: Baseline and benefit at the end of 30 day field use
measure: Digits-in-noise Test (DIN)
timeFrame: Baseline unaided test and aided fitting final assessment after 30 day field use
measure: Live Speech Mapping Using Real Ear Measurements (REM)
timeFrame: Final assessment after 30 day field use
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: University of Pretoria
state: Gauteng
Study officials:
affiliation: hearX Group
name: De Wet Swanepoel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Keidser G, Convery E. Self-Fitting Hearing Aids: Status Quo and Future Predictions. Trends Hear. 2016 Apr 12;20:2331216516643284. doi: 10.1177/2331216516643284.