Clinical Validation of the Lexie Lumen Hearing Aid
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

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).
    

Intervention name(s): Lexie Self Test and Fit Group; Lexie Professional Test and Fit Group
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): Lexie STF); Lexie PFT
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hearing loss; hearing aid; hearing rehabilitation; self-fitting hearing aid