Adults 18 to 99, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Abbreviated Profile of Hearing Aid Benefit (APHAB)Primary· Change from baseline assessment to final assessment after 30 day field trial use.
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 un
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
30.1
± 21.9
Control: Lexie Professional Test and Fit Group (Lexie PTF)
21.4
± 21.5
International Outcome Inventory for Hearing Aids (IOI-HA)Secondary· Final assessment after 30 day field use
IOI HA is a seven item questionnaire designed to evaluate effectiveness of hearing aid treatment. The responses of the items are assigned a value of 1 to 5, with higher scores indicating a more favorable outcome. The total score is calculated as the sum of all the subscales. Minimum score for the total score is 7 and maximum score 35.
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
31
30 – 33
Control: Lexie Professional Test and Fit Group (Lexie PTF)
31
28 – 34
QuickSIN Speech in Noise TestSecondary· Baseline and benefit at the end of 30 day field use
The QuickSIN measures a persons ability to accurately hear speech in noise by determining a signal-to-noise ratio loss. A list of six sentences with five key words per sentence is presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult). To score, the number of correctly repeated words from each of the six sentences are counted. The SNR loss is calculated by subtracting the total number of correct words from 25.5. Three lists are averaged to obtain an average SNR score.
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
1.6
± 4.4
Control: Lexie Professional Test and Fit Group (Lexie PTF)
3.5
± 4.5
Digits-in-noise Test (DIN)Secondary· Baseline unaided test and aided fitting final assessment after 30 day field use
The DIN measure primarily the auditory, or bottom-up, speech recognition abilities in noise. The test determines a speech reception threshold by presenting spoken digit triplets (e.g., 3-4-7) in speech weighted background masking noise. Twenty three digits are presented adaptively at different signal to noise ratios, based on correct or incorrect recognition of the digits. The speech reception threshold is determined by averaging the signal to noise ratios of the last 19 digit triplets. Benefit scores are calculated as unaided baseline- aided at 30 days after field trial use. Benefit scores ar
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
.50
± 2.6
Control: Lexie Professional Test and Fit Group (Lexie PTF)
0.13
± 4.7
Live Speech Mapping Using Real Ear Measurements (REM)Secondary· Final assessment after 30 day field use
Real Ear Measurements (REM) involves placing a fine probe microphone into the ear canal to measure the sound at the eardrum. The hearing aid will be inserted in the ear alongside the probe microphone to measure the amplification effect within the patients ear taking into account the patient ear acoustics. Adjustments to the hearing aid can be made and measurement to best match the prescription target. The specific REM measure used will be Live Speech Mapping, which assesses the hearing aid output using realistic speech presented via a loudspeaker with the hearing aid in its normal mode of oper
250Hz
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
0.6
± 2.5
Control: Lexie Professional Test and Fit Group (Lexie PTF)
3.0
± 4.1
500Hz
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
1.3
± 3.1
Control: Lexie Professional Test and Fit Group (Lexie PTF)
2.7
± 4.0
1000 Hz
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
4.7
± 6.2
Control: Lexie Professional Test and Fit Group (Lexie PTF)
4.3
± 6.4
2000 Hz
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
-2.7
± 6.8
Control: Lexie Professional Test and Fit Group (Lexie PTF)
0.6
± 6.5
4000 Hz
Group
Value
95% CI
Experimental : Lexie Self Test and Fit Group (Lexie STF)
6.9
± 7.6
Control: Lexie Professional Test and Fit Group (Lexie PTF)
4.4
± 6.4
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation
· NA
· recruiting
NCT07506408 — Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Gene
· NA
· recruiting
NCT07218913 — Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III
· Phase 1
· recruiting
NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
· NA
· recruiting
NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
· NA
· recruiting
Other hearX Group trials
Trials by the same sponsor.
NCT05782153 — Comparing Self-Fitting Strategies in the Lexie Powered by Bose Hearing Aids
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by hearX Group
Last refreshed: 20 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05337748.